A Study to Evaluate Efficacy and Safety of LCI699 in Participants With Essential Hypertension

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00758524

Collaborator

(none)

628

Enrollment

Location

Arms

9.7

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study was a proof-of-efficacy, dose finding study of LCI699 in participants with mild-to-moderate uncomplicated essential hypertension in order to assess the blood pressure (BP) lowering effect, safety and tolerability of LCI699 as compared to placebo and eplerenone.

Condition or Disease	Intervention/Treatment	Phase
Essential Hypertension	Drug: LCI699 Drug: Eplerenone Drug: LCI699-matching Placebo Drug: Eplerenone-matching Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

628 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Multi-center, Randomized, Double-blind, Placebo and Active Controlled, Parallel Group, Dose Finding Study to Evaluate the Efficacy and Safety of LCI699 Compared to Placebo After 8 Weeks Treatment in Patients With Essential Hypertension

Actual Study Start Date :

Sep 11, 2008

Actual Primary Completion Date :

Jul 2, 2009

Actual Study Completion Date :

Jul 2, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Core Period: LCI699 0.25 mg QD Participants received LCI699 0.25 mg capsules, orally, once daily (QD), with or without food for up to 8 weeks.	Drug: LCI699 LCI699 oral capsules
Experimental: Core Period: LCI699 0.5 mg QD Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.	Drug: LCI699 LCI699 oral capsules
Experimental: Core Period: LCI699 1.0 mg QD Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.	Drug: LCI699 LCI699 oral capsules
Experimental: Core Period: LCI699 0.5 mg BID Participants received LCI699 0.5 mg capsules, orally, twice daily (BID), with or without food for up to 8 weeks.	Drug: LCI699 LCI699 oral capsules
Active Comparator: Core Period: Eplerenone 50 mg BID Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.	Drug: Eplerenone Eplerenone oral capsules
Placebo Comparator: Core Period: Placebo Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.	Drug: LCI699-matching Placebo LCI699-matching placebo oral capsules Drug: Eplerenone-matching Placebo Eplerenone-matching placebo oral capsules
Experimental: Withdrawal Period: LCI699 0.25 mg QD Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).	Drug: LCI699 LCI699 oral capsules
Placebo Comparator: Withdrawal Period: LCI699 0.25 mg QD Placebo Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).	Drug: LCI699-matching Placebo LCI699-matching placebo oral capsules
Experimental: Withdrawal Period: LCI699 0.5 mg QD Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).	Drug: LCI699 LCI699 oral capsules
Placebo Comparator: Withdrawal Period: LCI699 0.5 mg QD Placebo Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).	Drug: LCI699-matching Placebo LCI699-matching placebo oral capsules
Experimental: Withdrawal Period: LCI699 1.0 mg QD Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).	Drug: LCI699 LCI699 oral capsules
Placebo Comparator: Withdrawal Period: LCI699 1.0 mg QD Placebo Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).	Drug: LCI699-matching Placebo LCI699-matching placebo oral capsules
Experimental: Withdrawal Period: LCI699 0.5 mg BID Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Drug: LCI699 LCI699 oral capsules
Placebo Comparator: Withdrawal Period: LCI699 0.5 mg BID Placebo Participants received LCI699 matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Drug: LCI699-matching Placebo LCI699-matching placebo oral capsules
Active Comparator: Withdrawal Period: Eplerenone 50 mg BID Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Drug: Eplerenone Eplerenone oral capsules
Placebo Comparator: Withdrawal Period: Eplerenone 50 mg BID Placebo Participants received eplerenone matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Drug: Eplerenone-matching Placebo Eplerenone-matching placebo oral capsules
Placebo Comparator: Withdrawal Period: Placebo Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 1 week (Week 8 to Week 9).	Drug: LCI699-matching Placebo LCI699-matching placebo oral capsules Drug: Eplerenone-matching Placebo Eplerenone-matching placebo oral capsules

Outcome Measures

Primary Outcome Measures

Core Period: Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8 Last Observation Carried Forward (LOCF), as Measured by Office Blood Pressure (OBP) [Baseline, Week 8]
Automated arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the Guidelines for management of hypertension: report of the 4th working party of the British Hypertension Society, 2004-BHS IV, using an automated BP device (such as the Omron BP monitor). The change in the MSDBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSDBP was analyzed using an analysis of covariance model (ANCOVA) with treatment and region as factors and baseline MSDBP level as a covariate.

Secondary Outcome Measures

Core Period: Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8 LOCF, as Measured by OBP [Baseline, Week 8]
Automated arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the Guidelines for management of hypertension: report of the 4th working party of the British Hypertension Society, 2004-BHS IV, using an automated BP device (such as the Omron BP monitor). The change in the MSSBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSSBP was analyzed using an ANCOVA with treatment and region as factors and baseline MSSBP levels as a covariate.
Core Period: Number of Participants With Adverse Event (AEs), Serious Adverse Events (SAEs), and Deaths [AEs: From start of the study drug treatment up to 8 weeks; SAE: From signing of the informed consent up to 8 weeks]
An AE was an adverse medical event which occurs in a participant of the study and which is not necessarily in a causal relationship with the treatment the participant receives. SAEs were AEs leading to death, are life-threatening, require hospitalizations or prolongation of hospitalizations, represent an innate malformation or a congenital abnormality.
Core Period: Dose Response Relationship of LCI699 as Measured by Change From Baseline in MSDBP at Week 8 [Baseline, Week 8]
Automated arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the Guidelines for management of hypertension: report of the 4th working party of the British Hypertension Society, 2004-BHS IV, using an automated BP device (such as the Omron BP monitor). The change in the MSDBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSDBP was analyzed using an analysis of covariance model (ANCOVA) with treatment and region as factors and baseline MSDBP level as a covariate.
Core Period: Dose Response Relationship of LCI699 as Measured by Change From Baseline in MSSBP at Week 8 [Baseline, Week 8]
Automated arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the Guidelines for management of hypertension: report of the 4th working party of the British Hypertension Society, 2004-BHS IV, using an automated BP device (such as the Omron BP monitor). The change in the MSSBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSSBP was analyzed using an ANCOVA with treatment and region as factors and baseline MSSBP levels as a covariate.
Core Period: Change From Baseline in Mean 24 Hour Ambulatory SBP at Week 8 as Measured by Ambulatory Blood Pressure Monitoring (ABPM) [Baseline, Week 8]
An ABPM measured a participant's BP over a 24-hour period readings using an automated validated monitoring device from Baseline to Week 8. The 24-hour SBP was calculated by taking the mean of all ambulatory SBP readings for the 24-hour period.
Core Period: Change From Baseline in Mean 24 Hour Ambulatory DBP at Week 8, as Measured by ABPM [Baseline, Week 8]
An ABPM measured a participant's BP over a 24-hour period readings using an automated validated monitoring device from Baseline to Week 8. The 24-hour DBP was calculated by taking the mean of all ambulatory DBP readings for the 24-hour period.
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8 [Baseline, every hour up to 24 hours post-dose at Week 8]
Trough to peak ratios were derived from an ANCOVA model containing treatment, region, hour, treatment by hour interaction as factors with Baseline as a covariate.
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8 [Baseline, every hour up to 24 hours post-dose at Week 8]
Trough to peak ratios were derived from an ANCOVA model containing treatment, region, hour, treatment by hour interaction as factors with Baseline as a covariate.
Core Period: Change From Baseline in Plasma Aldosterone Levels at Week 8 [Baseline, Week 8]
Change from baseline was analyzed using plasma aldosterone values measured at Baseline and Week 8.
Core Period: Percentage of Participants With a MSDBP Response and MSDBP Control at Week 8 LOCF [Baseline, Week 8]
MSDBP response was defined as the percentage of participants with a MSDBP <90 mmHg or a >=10 mmHg reduction from Baseline. MSDBP control was defined as the percentage of participants with a MSDBP <90 mmHg.
Core Period: Percentage of Participants With a MSSBP Response and MSSBP Control at Week 8 LOCF [Baseline, Week 8]
MSSBP response was defined as the percentage of participants with a MSSBP <140 mmHg or a >=20 mmHg reduction from baseline reduction from baseline. MSSBP control was defined as the percentage of participants with a MSSBP <140 mmHg.
Core Period: Change From Baseline in Plasma Cortisol Levels by Adrenocorticotropic Hormone (ACTH) Stimulation Test [Baseline, 1 hour post-dose at Week 8]
The ACTH stimulation cortisol test was a standard procedure to measure the ability of adrenal cortex to respond to exogenous ACTH and directly assess the adrenal reserve. Serum cortisol concentrations at 1 hour after injection were measured to assess the maximum stimulated cortisol level achieved. Potential adrenal suppression was indicated if the serum cortisol concentration was <500 nanomoles per liter (nmol/L) at 1 hour after the injection.
Withdrawal Period: Change From Week 8 to Week 9 in MSDBP at Week 9, as Measured by OBP [From Week 8 to Week 9]
Automated arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the Guidelines for management of hypertension: report of the 4th working party of the British Hypertension Society, 2004-BHS IV, using an automated BP device (such as the Omron BP monitor). The change in the MSDBP was calculated comparing the Week 9 readings to the readings taken at Week 8 (Baseline). The change from Week 8 to week 9 in MSDBP was analyzed using an ANCOVA with treatment and region as factors and Week 8 MSDBP level as a covariate.
Withdrawal Period: Change From Week 8 to Week 9 in MSSBP at Week 9 as Measured by OBP [From Week 8 to Week 9]
Automated arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the Guidelines for management of hypertension: report of the 4th working party of the British Hypertension Society, 2004-BHS IV, using an automated BP device (such as the Omron BP monitor). The change in the MSSBP was calculated comparing the Week 9 readings to the readings taken at Week 8 (Baseline). The change from Week 8 to week 9 in MSSBP was analyzed using an ANCOVA with treatment and region as factors and Week 8 MSSBP level as a covariate.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Males and non-fertile females.
18-75 years inclusive.
Participants with mild-to-moderate uncomplicated essential hypertension.

Exclusion Criteria:

All women of child bearing potential.
Female participants on hormone replacement therapy.
Severe hypertension.
History or evidence of a secondary form of hypertension.
Known moderate or malignant retinopathy.
History of angina pectoris, myocardial infarction, coronary bypass surgery,ischemic heart disease, surgical or percutaneous arterial intervention of any kind (coronary, carotid or peripheral vessels), stroke, transient ischemic attack (TIA), carotid artery stenosis, aortic aneurysm or peripheral arterial disease.
Type 1 or type 2 diabetes mellitus.
Clinically significant valvular heart disease.
Congestive heart failure (New York Heart Association [NYHA] class II-IV).
Cardiac electrical abnormalities indicating significant risk of safety for participant taking part in the study.
History of malignancy of any organ system, treated or untreated, within the past 5 years.
Liver disease such as cirrhosis or chronic active hepatitis.
Any surgical or medical conditions that may significantly alter the absorption, distribution, metabolism or excretion of any drug substance
Any surgical or medical conditions, not identified in the protocol that in the opinion of the investigator or the monitor, place the participant at higher risk from his/her participation in the study, or is likely to prevent the participant from complying with the requirements of the study or completing the trial period.
Participant unwilling or not able to discontinue safely the use of current antihypertensive medications during the study period
Any contraindication or history of hypersensitivity to any of the study drugs or to drugs with similar chemical structures.
Chronic oral or parenteral corticosteroid treatment.
Treatment with potassium supplement or potassium sparing diuretics.
Treatment with potent cytochrome P450 3A4 (CYP3A4) inhibitors during the study period.
Use of other investigational drugs at Visit 1, or within 30 days or 5 half-lives of Visit 1, whichever is longer, unless local health authority guidelines mandate a longer period.
Serum potassium > 5.2 milliequivalents per liter (mEq/L) or < 3.5 mEq/L at Visit 1.
Serum sodium < 132 mEq/L at Visit 1.
Aspartate aminotransferase (ALT) or alanine aminotransferase (AST) > 2 times the upper limit of the normal range (ULN) at Visit 1.
Bilirubin (total) > 1.5 x ULN at Visit 1.
Modification of diet in renal disease estimated glomerular filtration rate (MDRD eGFR) < 60 milliliters per minute (ml/min)/1.73 m^2 at Visit 1.
Other clinically significant laboratory abnormalities, confirmed by repeat measurements, at Visit 1.
History of active substance abuse (including alcohol).
Participants with night-shift employment.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Pharmaceuticals	East Hanover	New Jersey	United States

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Novartis Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00758524

Other Study ID Numbers:

CLCI699A2201

First Posted:

Sep 25, 2008

Last Update Posted:

Jul 6, 2021

Last Verified:

Jun 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Novartis Pharmaceuticals

Essential hypertension

Phase 2 study

Antihypertensive agent

Additional relevant MeSH terms:

Hypertension

Essential Hypertension

Eplerenone

Study Results

Participant Flow

Recruitment Details	Participants took part at 84 investigative sites in Argentina, Australia, France, Germany, Netherlands, Romania, Spain, Sweden, and the United States from 11 September 2008 to 02 July 2009.
Pre-assignment Detail	A total of 628 participants were enrolled in the study. Out of 628, only 524 participants with essential hypertension were randomized to receive LCI699 or eplerenone in comparison with placebo for 8 weeks, followed by a randomized withdrawal period to either continue the treatment arm they were randomized to or to take placebo for one additional week (Week 9).

Arm/Group Title	Core Period: LCI699 0.25 mg QD	Core Period: LCI699 0.5 mg QD	Core Period: LCI699 1.0 mg QD	Core Period: LCI699 0.5 mg BID	Core Period: Eplerenone 50 mg BID	Core Period: Placebo	Withdrawal Period: LCI699 0.25 mg QD	Withdrawal Period: LCI699 0.25 mg QD Placebo	Withdrawal Period: LCI699 0.5 mg QD	Withdrawal Period: LCI699 0.5 mg QD Placebo	Withdrawal Period: LCI699 1.0 mg QD	Withdrawal Period: LCI699 1.0 mg QD Placebo	Withdrawal Period: LCI699 0.5 mg BID	Withdrawal Period: LCI699 0.5 mg BID Placebo	Withdrawal Period: Eplerenone 50 mg BID	Withdrawal Period: Eplerenone 50 mg BID Placebo	Withdrawal Period: Placebo
Arm/Group Description	Participants received LCI699 0.25 mg capsules, orally, once daily (QD), with or without food for up to 8 weeks.	Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.	Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.	Participants received LCI699 0.5 mg capsules, orally, twice daily (BID), with or without food for up to 8 weeks.	Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.	Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.	Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).	Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).	Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).	Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).	Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).	Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).	Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Participants received LCI699 matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Participants received eplerenone matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 1 week (Week 8 to Week 9).
Period Title: Core Period (Week 0 to Week 8)
STARTED	92	88	86	97	84	77	0	0	0	0	0	0	0	0	0	0	0
Treated	92	87	87	97	84	76	0	0	0	0	0	0	0	0	0	0	0
COMPLETED	84	81	77	90	75	67	0	0	0	0	0	0	0	0	0	0	0
NOT COMPLETED	8	7	9	7	9	10	0	0	0	0	0	0	0	0	0	0	0
Period Title: Core Period (Week 0 to Week 8)
STARTED	0	0	0	0	0	0	46	38	44	37	41	37	45	45	39	36	66
Randomized Withdrawal Set	0	0	0	0	0	0	45	38	43	37	41	36	45	44	39	36	67
COMPLETED	0	0	0	0	0	0	45	38	42	37	41	37	45	45	39	36	66
NOT COMPLETED	0	0	0	0	0	0	1	0	2	0	0	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Core Period: LCI699 0.25 mg QD	Core Period: LCI699 0.5 mg QD	Core Period: LCI699 1.0 mg QD	Core Period: LCI699 0.5 mg BID	Core Period: Eplerenone 50 mg BID	Core Period: Placebo	Total
Arm/Group Description	Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.	Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.	Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.	Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.	Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.	Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.	Total of all reporting groups
Overall Participants	92	87	86	96	84	77	522
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.9 (10.5)	54.8 (7.8)	54.5 (9.7)	54.4 (10.8)	55.3 (9.1)	53.9 (8.7)	54.5 (9.50)
Sex: Female, Male (Count of Participants)
Female	29 31.5%	29 33.3%	31 36%	33 34.4%	28 33.3%	31 40.3%	181 34.7%
Male	63 68.5%	58 66.7%	55 64%	63 65.6%	56 66.7%	46 59.7%	341 65.3%
Blood Pressure (millimeters of mercury (mm Hg)) [Mean (Standard Deviation) ]
Clinic Systolic Blood Pressure (SBP)	157.72 (12.163)	157.04 (11.580)	159.24 (10.415)	158.50 (11.028)	158.20 (10.954)	156.69 (10.121)	157.93 (11.074)
Clinic Diastolic Blood pressure (DBP)	100.43 (3.884)	99.94 (3.314)	100.03 (3.580)	100.21 (3.450)	100.39 (3.607)	100.54 (3.814)	100.25 (3.599)
24-hour Ambulatory SBP	141.97 (11.167)	140.08 (13.502)	143.85 (11.613)	142.20 (11.079)	143.30 (13.989)	142.07 (13.150)	142.25 (12.405)
24-hour Ambulatory DBP	90.13 (8.893)	89.33 (8.208)	91.38 (7.998)	90.81 (8.260)	91.14 (8.861)	90.11 (10.439)	90.49 (8.744)

Outcome Measures

1. Primary Outcome

Title	Core Period: Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8 Last Observation Carried Forward (LOCF), as Measured by Office Blood Pressure (OBP)
Description	Automated arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the Guidelines for management of hypertension: report of the 4th working party of the British Hypertension Society, 2004-BHS IV, using an automated BP device (such as the Omron BP monitor). The change in the MSDBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSDBP was analyzed using an analysis of covariance model (ANCOVA) with treatment and region as factors and baseline MSDBP level as a covariate.
Time Frame	Baseline, Week 8

Outcome Measure Data

Analysis Population Description
FAS population included all randomized participants or participants that met the inclusion criteria as described in study documentation protocol excluding misrandomized participants or participants with protocol violations. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.

Arm/Group Title	Core Period: LCI699 0.25 mg QD	Core Period: LCI699 0.5 mg QD	Core Period: LCI699 1.0 mg QD	Core Period: LCI699 0.5 mg BID	Core Period: Eplerenone 50 mg BID	Core Period: Placebo
Arm/Group Description	Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.	Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.	Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.	Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.	Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.	Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.
Measure Participants	92	85	86	96	84	76
Mean (Standard Error) [mm Hg]	-4.47 (0.60)	-5.50 (0.57)	-7.11 (0.88)	-4.25 (0.95)	-7.49 (0.97)	-3.22 (0.87)

2. Secondary Outcome

Title	Core Period: Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8 LOCF, as Measured by OBP
Description	Automated arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the Guidelines for management of hypertension: report of the 4th working party of the British Hypertension Society, 2004-BHS IV, using an automated BP device (such as the Omron BP monitor). The change in the MSSBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSSBP was analyzed using an ANCOVA with treatment and region as factors and baseline MSSBP levels as a covariate.
Time Frame	Baseline, Week 8

Outcome Measure Data

Analysis Population Description
FAS population included all randomized participants or participants that met the inclusion criteria as described in study documentation protocol excluding misrandomized participants or participants with protocol violations. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.

Arm/Group Title	Core Period: LCI699 0.25 mg QD	Core Period: LCI699 0.5 mg QD	Core Period: LCI699 1.0 mg QD	Core Period: LCI699 0.5 mg BID	Core Period: Eplerenone 50 mg BID	Core Period: Placebo
Arm/Group Description	Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.	Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.	Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.	Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.	Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.	Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.
Measure Participants	92	85	86	96	84	76
Mean (Standard Error) [mm Hg]	-9.00 (1.40)	-10.69 (0.98)	-11.93 (1.44)	-9.10 (1.45)	-13.31 (1.48)	-2.93 (1.68)

3. Secondary Outcome

Title	Core Period: Number of Participants With Adverse Event (AEs), Serious Adverse Events (SAEs), and Deaths
Description	An AE was an adverse medical event which occurs in a participant of the study and which is not necessarily in a causal relationship with the treatment the participant receives. SAEs were AEs leading to death, are life-threatening, require hospitalizations or prolongation of hospitalizations, represent an innate malformation or a congenital abnormality.
Time Frame	AEs: From start of the study drug treatment up to 8 weeks; SAE: From signing of the informed consent up to 8 weeks

Outcome Measure Data

Analysis Population Description
Safety Set included all the participants who received at least 1 dose of study drug.

Arm/Group Title	Core Period: LCI699 0.25 mg QD	Core Period: LCI699 0.5 mg QD	Core Period: LCI699 1.0 mg QD	Core Period: LCI699 0.5 mg BID	Core Period: Eplerenone 50 mg BID	Core Period: Placebo
Arm/Group Description	Participants received LCI699 0.25 mg capsules, orally, once daily (QD), with or without food for up to 8 weeks.	Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.	Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.	Participants received LCI699 0.5 mg capsules, orally, twice daily (BID), with or without food for up to 8 weeks.	Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.	Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.
Measure Participants	92	87	87	97	84	76
AEs	23 25%	22 25.3%	24 27.9%	27 28.1%	26 31%	23 29.9%
SAEs	1 1.1%	0 0%	0 0%	0 0%	0 0%	1 1.3%
Deaths	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

4. Secondary Outcome

Title	Core Period: Dose Response Relationship of LCI699 as Measured by Change From Baseline in MSDBP at Week 8
Description	Automated arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the Guidelines for management of hypertension: report of the 4th working party of the British Hypertension Society, 2004-BHS IV, using an automated BP device (such as the Omron BP monitor). The change in the MSDBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSDBP was analyzed using an analysis of covariance model (ANCOVA) with treatment and region as factors and baseline MSDBP level as a covariate.
Time Frame	Baseline, Week 8

Outcome Measure Data

Analysis Population Description
FAS population included all randomized participants or participants that met the inclusion criteria as described in study documentation protocol excluding misrandomized participants or participants with protocol violations. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.

Arm/Group Title	Core Period: LCI699 0.25 mg QD	Core Period: LCI699 0.5 mg QD	Core Period: LCI699 1.0 mg QD	Core Period: LCI699 0.5 mg BID
Arm/Group Description	Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.	Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.	Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.	Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.
Measure Participants	92	85	86	96
Mean (Standard Error) [mm Hg]	-4.47 (0.60)	-5.50 (0.57)	-7.11 (0.88)	-4.25 (0.95)

5. Secondary Outcome

Title	Core Period: Dose Response Relationship of LCI699 as Measured by Change From Baseline in MSSBP at Week 8
Description	Automated arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the Guidelines for management of hypertension: report of the 4th working party of the British Hypertension Society, 2004-BHS IV, using an automated BP device (such as the Omron BP monitor). The change in the MSSBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSSBP was analyzed using an ANCOVA with treatment and region as factors and baseline MSSBP levels as a covariate.
Time Frame	Baseline, Week 8

Outcome Measure Data

Analysis Population Description
FAS population included all randomized participants or participants that met the inclusion criteria as described in study documentation protocol excluding misrandomized participants or participants with protocol violations. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.

Arm/Group Title	Core Period: LCI699 0.25 mg QD	Core Period: LCI699 0.5 mg QD	Core Period: LCI699 1.0 mg QD	Core Period: LCI699 0.5 mg BID
Arm/Group Description	Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.	Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.	Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.	Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.
Measure Participants	92	85	86	96
Mean (Standard Error) [mm Hg]	-9.00 (1.40)	-10.69 (0.98)	-11.93 (1.44)	-9.10 (1.45)

6. Secondary Outcome

Title	Core Period: Change From Baseline in Mean 24 Hour Ambulatory SBP at Week 8 as Measured by Ambulatory Blood Pressure Monitoring (ABPM)
Description	An ABPM measured a participant's BP over a 24-hour period readings using an automated validated monitoring device from Baseline to Week 8. The 24-hour SBP was calculated by taking the mean of all ambulatory SBP readings for the 24-hour period.
Time Frame	Baseline, Week 8

Outcome Measure Data

Analysis Population Description
FAS population included all randomized participants or participants that met the inclusion criteria as described in study documentation protocol excluding misrandomized participants or participants with protocol violations. Overall number of participants signifies the number of participants in the FAS who have a Baseline and a Week 8 mean 24-hour ABPM sitting SBP assessment.

Arm/Group Title	Core Period: LCI699 0.25 mg QD	Core Period: LCI699 0.5 mg QD	Core Period: LCI699 1.0 mg QD	Core Period: LCI699 0.5 mg BID	Core Period: Eplerenone 50 mg BID	Core Period: Placebo
Arm/Group Description	Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.	Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.	Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.	Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.	Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.	Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.
Measure Participants	62	59	68	70	57	52
Least Squares Mean (Standard Error) [mm Hg]	-7.15 (1.20)	-4.90 (1.22)	-7.73 (1.13)	-6.18 (1.14)	-10.52 (1.25)	1.11 (1.30)

7. Secondary Outcome

Title	Core Period: Change From Baseline in Mean 24 Hour Ambulatory DBP at Week 8, as Measured by ABPM
Description	An ABPM measured a participant's BP over a 24-hour period readings using an automated validated monitoring device from Baseline to Week 8. The 24-hour DBP was calculated by taking the mean of all ambulatory DBP readings for the 24-hour period.
Time Frame	Baseline, Week 8

Outcome Measure Data

Analysis Population Description
FAS population included all randomized participants or participants that met the inclusion criteria as described in study documentation protocol excluding misrandomized participants or participants with protocol violations. Overall number of participants signifies the number of participants in the FAS who have a Baseline and a Week 8 mean 24-hour ABPM sitting DBP assessment.

Arm/Group Title	Core Period: LCI699 0.25 mg QD	Core Period: LCI699 0.5 mg QD	Core Period: LCI699 1.0 mg QD	Core Period: LCI699 0.5 mg BID	Core Period: Eplerenone 50 mg BID	Core Period: Placebo
Arm/Group Description	Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.	Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.	Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.	Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.	Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.	Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.
Measure Participants	62	59	68	70	57	52
Least Squares Mean (Standard Error) [mm Hg]	-4.03 (0.91)	-2.44 (0.92)	-4.96 (0.86)	-2.75 (0.86)	-6.03 (0.94)	1.03 (0.99)

8. Secondary Outcome

Title	Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8
Description	Trough to peak ratios were derived from an ANCOVA model containing treatment, region, hour, treatment by hour interaction as factors with Baseline as a covariate.
Time Frame	Baseline, every hour up to 24 hours post-dose at Week 8

Outcome Measure Data

Analysis Population Description
FAS population included all randomized participants or participants that met the inclusion criteria as described in study documentation protocol excluding misrandomized participants or participants with protocol violations.

Arm/Group Title	Core Period: LCI699 0.25 mg QD	Core Period: LCI699 0.5 mg QD	Core Period: LCI699 1.0 mg QD	Core Period: LCI699 0.5 mg BID	Core Period: Eplerenone 50 mg BID	Core Period: Placebo
Arm/Group Description	Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.	Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.	Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.	Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.	Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.	Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.
Measure Participants	92	87	86	96	84	77
Week 8, Hour 1	3.91 (1.466)	2.95 (1.541)	0.27 (1.389)	3.87 (1.404)	0.17 (1.544)	7.11 (1.588)
Week 8, Hour 2	1.44 (1.452)	1.85 (1.488)	0.17 (1.397)	3.44 (1.381)	-1.65 (1.529)	6.28 (1.586)
Week 8, Hour 3	1.16 (1.477)	1.13 (1.502)	-0.36 (1.387)	4.01 (1.369)	-2.42 (1.528)	4.99 (1.585)
Week 8, Hour 4	0.51 (1.452)	2.91 (1.488)	0.35 (1.386)	2.64 (1.378)	-1.39 (1.541)	7.02 (1.584)
Week 8, Hour 5	1.11 (1.463)	-0.02 (1.513)	-1.69 (1.385)	1.45 (1.377)	-2.91 (1.514)	4.31 (1.584)
Week 8, Hour 6	-1.18 (1.451)	-2.36 (1.487)	-3.01 (1.386)	1.20 (1.367)	-4.86 (1.513)	1.82 (1.585)
Week 8, Hour 7	-1.85 (1.463)	-0.95 (1.487)	-2.63 (1.406)	1.21 (1.366)	-3.70 (1.513)	3.62 (1.599)
Week 8, Hour 8	-3.01 (1.464)	-1.38 (1.487)	-2.43 (1.396)	2.09 (1.366)	-2.30 (1.514)	2.65 (1.616)
Week 8, Hour 9	-1.24 (1.464)	-0.07 (1.487)	-2.25 (1.386)	3.27 (1.366)	-2.81 (1.515)	3.30 (1.600)
Week 8, Hour 10	-0.59 (1.452)	2.60 (1.487)	-1.65 (1.385)	0.49 (1.378)	-2.43 (1.515)	3.86 (1.585)
Week 8, Hour 11	-1.02 (1.451)	1.72 (1.487)	-1.54 (1.386)	1.54 (1.367)	-1.93 (1.514)	2.38 (1.585)
Week 8, Hour 12	-1.60 (1.451)	2.53 (1.487)	-3.10 (1.385)	-1.06 (1.367)	-3.20 (1.527)	3.24 (1.584)
Week 8, Hour 13	-4.32 (1.451)	-1.20 (1.487)	-5.31 (1.385)	-1.45 (1.366)	-5.35 (1.513)	1.52 (1.584)
Week 8, Hour 14	-6.47 (1.451)	-3.29 (1.487)	-7.38 (1.385)	-2.96 (1.376)	-7.64 (1.513)	-0.90 (1.584)
Week 8, Hour 15	-8.34 (1.452)	-5.82 (1.488)	-8.89 (1.386)	-6.10 (1.377)	-9.03 (1.527)	-1.01 (1.586)
Week 8, Hour 16	-8.92 (1.465)	-8.37 (1.491)	-10.50 (1.387)	-9.54 (1.369)	-12.55 (1.528)	-1.61 (1.587)
Week 8, Hour 17	-10.26 (1.454)	-10.99 (1.492)	-12.71 (1.398)	-10.38 (1.380)	-12.88 (1.516)	-4.20 (1.604)
Week 8, Hour 18	-10.68 (1.456)	-11.73 (1.492)	-11.88 (1.389)	-11.85 (1.379)	-13.49 (1.529)	-6.89 (1.587)
Week 8, Hour 19	-10.13 (1.456)	-10.12 (1.493)	-9.74 (1.388)	-10.78 (1.369)	-10.13 (1.517)	-5.84 (1.587)
Week 8, Hour 20	-10.73 (1.454)	-8.06 (1.504)	-10.43 (1.408)	-10.49 (1.369)	-10.47 (1.516)	-5.21 (1.602)
Week 8, Hour 21	-9.31 (1.453)	-7.68 (1.489)	-9.66 (1.386)	-8.22 (1.377)	-10.51 (1.514)	-4.12 (1.586)
Week 8, Hour 22	-7.90 (1.452)	-4.93 (1.487)	-5.37 (1.385)	-6.35 (1.386)	-7.60 (1.513)	-1.09 (1.585)
Week 8, Hour 23	-4.94 (1.475)	-1.93 (1.487)	-1.18 (1.385)	-2.67 (1.377)	-5.54 (1.513)	1.82 (1.599)
Week 8, Hour 24	-0.21 (1.477)	1.45 (1.501)	0.29 (1.397)	1.36 (1.370)	-2.78 (1.529)	1.98 (1.617)

9. Secondary Outcome

Title	Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8
Description	Trough to peak ratios were derived from an ANCOVA model containing treatment, region, hour, treatment by hour interaction as factors with Baseline as a covariate.
Time Frame	Baseline, every hour up to 24 hours post-dose at Week 8

Outcome Measure Data

Analysis Population Description
FAS population included all randomized participants or participants that met the inclusion criteria as described in study documentation protocol excluding misrandomized participants or participants with protocol violations.

Arm/Group Title	Core Period: LCI699 0.25 mg QD	Core Period: LCI699 0.5 mg QD	Core Period: LCI699 1.0 mg QD	Core Period: LCI699 0.5 mg BID	Core Period: Eplerenone 50 mg BID	Core Period: Placebo
Arm/Group Description	Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.	Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.	Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.	Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.	Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.	Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.
Measure Participants	92	87	86	96	84	77
Week 8, Hour 1	-0.54 (1.767)	0.09 (1.859)	-4.51 (1.674)	-1.42 (1.690)	-5.33 (1.863)	8.23 (1.915)
Week 8, Hour 2	-1.59 (1.752)	0.15 (1.795)	-3.56 (1.685)	-0.57 (1.663)	-5.90 (1.844)	6.48 (1.913)
Week 8, Hour 3	-2.11 (1.781)	-1.53 (1.811)	-4.86 (1.672)	0.91 (1.649)	-5.89 (1.843)	4.60 (1.912)
Week 8, Hour 4	-2.06 (1.752)	-1.18 (1.794)	-4.15 (1.672)	1.50 (1.661)	-5.12 (1.859)	4.68 (1.912)
Week 8, Hour 5	-4.29 (1.766)	-3.09 (1.825)	-3.47 (1.671)	-1.70 (1.660)	-7.22 (1.826)	2.78 (1.912)
Week 8, Hour 6	-4.21 (1.751)	-3.12 (1.794)	-5.88 (1.672)	-1.02 (1.648)	-7.91 (1.826)	1.42 (1.912)
Week 8, Hour 7	-4.95 (1.766)	-2.10 (1.794)	-5.40 (1.697)	-0.76 (1.649)	-8.70 (1.826)	2.25 (1.930)
Week 8, Hour 8	-5.28 (1.766)	-4.69 (1.794)	-5.30 (1.684)	-3.02 (1.649)	-8.06 (1.827)	3.76 (1.950)
Week 8, Hour 9	-3.98 (1.766)	-1.59 (1.795)	-4.78 (1.672)	-1.87 (1.649)	-7.46 (1.828)	2.39 (1.931)
Week 8, Hour 10	-3.69 (1.752)	-0.30 (1.794)	-3.40 (1.672)	-1.73 (1.662)	-7.35 (1.828)	2.54 (1.913)
Week 8, Hour 11	-2.47 (1.751)	-0.43 (1.795)	-4.22 (1.672)	-1.74 (1.649)	-5.75 (1.827)	3.51 (1.913)
Week 8, Hour 12	-5.19 (1.752)	0.73 (1.794)	-4.35 (1.671)	-3.92 (1.650)	-6.25 (1.843)	4.69 (1.912)
Week 8, Hour 13	-6.45 (1.751)	-2.30 (1.794)	-7.25 (1.671)	-4.05 (1.649)	-8.81 (1.826)	3.20 (1.912)
Week 8, Hour 14	-7.37 (1.751)	-5.68 (1.794)	-9.33 (1.671)	-6.12 (1.660)	-10.91 (1.826)	0.75 (1.912)
Week 8, Hour 15	-10.61 (1.752)	-8.28 (1.795)	-11.26 (1.672)	-9.78 (1.661)	-12.04 (1.842)	0.02 (1.912)
Week 8, Hour 16	-11.71 (1.767)	-10.01 (1.797)	-12.63 (1.672)	-13.03 (1.651)	-16.68 (1.843)	-0.33 (1.914)
Week 8, Hour 17	-13.71 (1.754)	-11.96 (1.799)	-15.46 (1.685)	-13.72 (1.664)	-19.59 (1.828)	-3.03 (1.933)
Week 8, Hour 18	-14.49 (1.756)	-14.37 (1.800)	-14.54 (1.675)	-15.60 (1.664)	-18.55 (1.844)	-6.35 (1.915)
Week 8, Hour 19	-13.78 (1.756)	-13.08 (1.801)	-12.85 (1.674)	-15.93 (1.652)	-15.49 (1.830)	-6.98 (1.914)
Week 8, Hour 20	-13.92 (1.756)	-13.22 (1.814)	-12.54 (1.699)	-15.47 (1.652)	-16.09 (1.829)	-6.53 (1.934)
Week 8, Hour 21	-14.33 (1.754)	-10.06 (1.797)	-12.78 (1.672)	-13.63 (1.662)	-15.34 (1.827)	-3.89 (1.914)
Week 8, Hour 22	-13.46 (1.752)	-8.35 (1.794)	-7.52 (1.671)	-10.55 (1.673)	-12.47 (1.826)	-0.94 (1.912)
Week 8, Hour 23	-7.88 (1.780)	-6.23 (1.794)	-5.77 (1.671)	-6.73 (1.661)	-9.02 (1.826)	2.18 (1.930)
Week 8, Hour 24	-3.16 (1.781)	-0.64 (1.810)	-3.45 (1.685)	-3.76 (1.651)	-8.90 (1.844)	0.70 (1.951)

10. Secondary Outcome

Title	Core Period: Change From Baseline in Plasma Aldosterone Levels at Week 8
Description	Change from baseline was analyzed using plasma aldosterone values measured at Baseline and Week 8.
Time Frame	Baseline, Week 8

Outcome Measure Data

Analysis Population Description
Safety Set included all the participants who received at least 1 dose of study drug. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.

Arm/Group Title	Core Period: LCI699 0.25 mg QD	Core Period: LCI699 0.5 mg QD	Core Period: LCI699 1.0 mg QD	Core Period: LCI699 0.5 mg BID	Core Period: Eplerenone 50 mg BID	Core Period: Placebo
Arm/Group Description	Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.	Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.	Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.	Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.	Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.	Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.
Measure Participants	71	69	70	76	64	54
Mean (Standard Deviation) [picomoles per liter (pmol/L)]	-21.5 (122)	-20.0 (156)	-9.9 (266)	-47.5 (170)	277.1 (429)	-28.8 (163)

11. Secondary Outcome

Title	Core Period: Percentage of Participants With a MSDBP Response and MSDBP Control at Week 8 LOCF
Description	MSDBP response was defined as the percentage of participants with a MSDBP <90 mmHg or a >=10 mmHg reduction from Baseline. MSDBP control was defined as the percentage of participants with a MSDBP <90 mmHg.
Time Frame	Baseline, Week 8

Outcome Measure Data

Analysis Population Description
FAS population included all randomized participants or participants that met the inclusion criteria as described in study documentation protocol excluding misrandomized participants or participants with protocol violations. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.

Arm/Group Title	Core Period: LCI699 0.25 mg QD	Core Period: LCI699 0.5 mg QD	Core Period: LCI699 1.0 mg QD	Core Period: LCI699 0.5 mg BID	Core Period: Eplerenone 50 mg BID	Core Period: Placebo
Arm/Group Description	Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.	Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.	Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.	Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.	Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.	Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.
Measure Participants	92	85	86	96	84	76
MSDBP Response	39.1 42.5%	34.1 39.2%	50.0 58.1%	34.4 35.8%	48.8 58.1%	27.6 35.8%
MSDBP Control	32.6 35.4%	29.4 33.8%	41.9 48.7%	29.2 30.4%	45.2 53.8%	18.4 23.9%

12. Secondary Outcome

Title	Core Period: Percentage of Participants With a MSSBP Response and MSSBP Control at Week 8 LOCF
Description	MSSBP response was defined as the percentage of participants with a MSSBP <140 mmHg or a >=20 mmHg reduction from baseline reduction from baseline. MSSBP control was defined as the percentage of participants with a MSSBP <140 mmHg.
Time Frame	Baseline, Week 8

Outcome Measure Data

Analysis Population Description
FAS population included all randomized participants or participants that met the inclusion criteria as described in study documentation protocol excluding misrandomized participants or participants with protocol violations. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.

Arm/Group Title	Core Period: LCI699 0.25 mg QD	Core Period: LCI699 0.5 mg QD	Core Period: LCI699 1.0 mg QD	Core Period: LCI699 0.5 mg BID	Core Period: Eplerenone 50 mg BID	Core Period: Placebo
Arm/Group Description	Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.	Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.	Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.	Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.	Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.	Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.
Measure Participants	92	85	86	96	84	76
MSSBP Response	39.1 42.5%	37.6 43.2%	48.8 56.7%	34.4 35.8%	52.4 62.4%	17.1 22.2%
MSSBP Control	31.5 34.2%	27.1 31.1%	40.7 47.3%	25.0 26%	44.0 52.4%	15.8 20.5%

13. Secondary Outcome

Title	Core Period: Change From Baseline in Plasma Cortisol Levels by Adrenocorticotropic Hormone (ACTH) Stimulation Test
Description	The ACTH stimulation cortisol test was a standard procedure to measure the ability of adrenal cortex to respond to exogenous ACTH and directly assess the adrenal reserve. Serum cortisol concentrations at 1 hour after injection were measured to assess the maximum stimulated cortisol level achieved. Potential adrenal suppression was indicated if the serum cortisol concentration was <500 nanomoles per liter (nmol/L) at 1 hour after the injection.
Time Frame	Baseline, 1 hour post-dose at Week 8

Outcome Measure Data

Analysis Population Description
ACTH subset population included all participants prior to treatment with LCI699 and at the end of the treatment interval (Week 8). Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure at the given timepoint

Arm/Group Title	Core Period: LCI699 0.25 mg QD	Core Period: LCI699 0.5 mg QD	Core Period: LCI699 1.0 mg QD	Core Period: LCI699 0.5 mg BID	Core Period: Eplerenone 50 mg BID	Core Period: Placebo
Arm/Group Description	Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.	Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.	Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.	Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.	Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.	Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.
Measure Participants	20	23	28	24	22	17
Mean (Standard Deviation) [nanomoles per liter (nmol/L)]	729.20 (123.753)	692.74 (117.645)	604.46 (125.017)	609.21 (107.923)	802.32 (134.497)	822.65 (116.041)

14. Secondary Outcome

Title	Withdrawal Period: Change From Week 8 to Week 9 in MSDBP at Week 9, as Measured by OBP
Description	Automated arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the Guidelines for management of hypertension: report of the 4th working party of the British Hypertension Society, 2004-BHS IV, using an automated BP device (such as the Omron BP monitor). The change in the MSDBP was calculated comparing the Week 9 readings to the readings taken at Week 8 (Baseline). The change from Week 8 to week 9 in MSDBP was analyzed using an ANCOVA with treatment and region as factors and Week 8 MSDBP level as a covariate.
Time Frame	From Week 8 to Week 9

Outcome Measure Data

Analysis Population Description
Randomized Withdrawal Set included all participants with post-baseline blood pressure measurements from Week 8 to Week 9 only. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.

Arm/Group Title	Withdrawal Period: LCI699 0.25 mg QD	Withdrawal Period: LCI699 0.25 mg QD Placebo	Withdrawal Period: LCI699 0.5 mg QD	Withdrawal Period: LCI699 0.5 mg QD Placebo	Withdrawal Period: LCI699 1.0 mg QD	Withdrawal Period: LCI699 1.0 mg QD Placebo	Withdrawal Period: LCI699 0.5 mg BID	Withdrawal Period: LCI699 0.5 mg BID Placebo	Withdrawal Period: Eplerenone 50 mg BID	Withdrawal Period: Eplerenone 50 mg BID Placebo	Withdrawal Period: Placebo
Arm/Group Description	Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).	Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).	Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).	Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).	Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).	Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).	Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Participants received LCI699 matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Participants received eplerenone matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 1 week (Week 8 to Week 9).
Measure Participants	45	38	43	37	41	36	45	44	39	36	67
Least Squares Mean (Standard Error) [mm Hg]	0.5 (0.99)	0.5 (1.08)	1.6 (1.01)	-0.2 (1.09)	-0.5 (1.03)	2.5 (1.11)	1.3 (1.00)	1.3 (1.02)	-1.2 (1.06)	0.4 (1.11)	1.6 (0.83)

15. Secondary Outcome

Title	Withdrawal Period: Change From Week 8 to Week 9 in MSSBP at Week 9 as Measured by OBP
Description	Automated arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the Guidelines for management of hypertension: report of the 4th working party of the British Hypertension Society, 2004-BHS IV, using an automated BP device (such as the Omron BP monitor). The change in the MSSBP was calculated comparing the Week 9 readings to the readings taken at Week 8 (Baseline). The change from Week 8 to week 9 in MSSBP was analyzed using an ANCOVA with treatment and region as factors and Week 8 MSSBP level as a covariate.
Time Frame	From Week 8 to Week 9

Outcome Measure Data

Analysis Population Description
Randomized Withdrawal Set included all participants with post-baseline blood pressure measurements from Week 8 to Week 9 only. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.

Arm/Group Title	Withdrawal Period: LCI699 0.25 mg QD	Withdrawal Period: LCI699 0.25 mg QD Placebo	Withdrawal Period: LCI699 0.5 mg QD	Withdrawal Period: LCI699 0.5 mg QD Placebo	Withdrawal Period: LCI699 1.0 mg QD	Withdrawal Period: LCI699 1.0 mg QD Placebo	Withdrawal Period: LCI699 0.5 mg BID	Withdrawal Period: LCI699 0.5 mg BID Placebo	Withdrawal Period: Eplerenone 50 mg BID	Withdrawal Period: Eplerenone 50 mg BID Placebo	Withdrawal Period: Placebo
Arm/Group Description	Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).	Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).	Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).	Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).	Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).	Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).	Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Participants received LCI699 matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Participants received eplerenone matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).	Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 1 week (Week 8 to Week 9).
Measure Participants	45	38	43	37	41	36	45	44	39	36	67
Least Squares Mean (Standard Error) [mm Hg]	0.3 (1.66)	3.3 (1.80)	0.5 (1.69)	2.5 (1.82)	0.4 (1.72)	5.3 (1.85)	1.6 (1.68)	4.4 (1.69)	-1.5 (1.79)	2.7 (1.86)	1.8 (1.39)

Adverse Events

	Core Period: LCI699 0.25 mg QD		Core Period: LCI699 0.5 mg QD		Core Period: LCI699 1.0 mg QD		Core Period: LCI699 0.5 mg BID		Core Period: Eplerenone 50 mg BID		Core Period: Placebo		Withdrawal Period: LCI699 0.25 mg QD		Withdrawal Period: LCI699 0.25 mg QD Placebo		Withdrawal Period: LCI699 0.5 mg QD		Withdrawal Period: LCI699 0.5 mg QD Placebo		Withdrawal Period: LCI699 1.0 mg QD		Withdrawal Period: LCI699 1.0 mg QD Placebo		Withdrawal Period: LCI699 0.5 mg BID		Withdrawal Period: LCI699 0.5 mg BID Placebo		Withdrawal Period: Eplerenone 50 mg BID		Withdrawal Period: Eplerenone 50 mg BID Placebo		Withdrawal Period: Placebo
Time Frame	AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks
Adverse Event Reporting Description	Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.

Arm/Group Title	Core Period: LCI699 0.25 mg QD		Core Period: LCI699 0.5 mg QD		Core Period: LCI699 1.0 mg QD		Core Period: LCI699 0.5 mg BID		Core Period: Eplerenone 50 mg BID		Core Period: Placebo		Withdrawal Period: LCI699 0.25 mg QD		Withdrawal Period: LCI699 0.25 mg QD Placebo		Withdrawal Period: LCI699 0.5 mg QD		Withdrawal Period: LCI699 0.5 mg QD Placebo		Withdrawal Period: LCI699 1.0 mg QD		Withdrawal Period: LCI699 1.0 mg QD Placebo		Withdrawal Period: LCI699 0.5 mg BID		Withdrawal Period: LCI699 0.5 mg BID Placebo		Withdrawal Period: Eplerenone 50 mg BID		Withdrawal Period: Eplerenone 50 mg BID Placebo		Withdrawal Period: Placebo
Arm/Group Description	Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.		Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.		Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.		Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.		Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.		Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.		Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).		Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).		Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).		Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).		Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).		Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).		Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).		Participants received LCI699 matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).		Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).		Participants received eplerenone-matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).		Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 1 week (Week 8 to Week 9).
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/92 (0%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Serious Adverse Events
	Core Period: LCI699 0.25 mg QD		Core Period: LCI699 0.5 mg QD		Core Period: LCI699 1.0 mg QD		Core Period: LCI699 0.5 mg BID		Core Period: Eplerenone 50 mg BID		Core Period: Placebo		Withdrawal Period: LCI699 0.25 mg QD		Withdrawal Period: LCI699 0.25 mg QD Placebo		Withdrawal Period: LCI699 0.5 mg QD		Withdrawal Period: LCI699 0.5 mg QD Placebo		Withdrawal Period: LCI699 1.0 mg QD		Withdrawal Period: LCI699 1.0 mg QD Placebo		Withdrawal Period: LCI699 0.5 mg BID		Withdrawal Period: LCI699 0.5 mg BID Placebo		Withdrawal Period: Eplerenone 50 mg BID		Withdrawal Period: Eplerenone 50 mg BID Placebo		Withdrawal Period: Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/92 (1.1%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		1/76 (1.3%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Eye disorders
Retinal vein occlusion	1/92 (1.1%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Gastrointestinal disorders
Abdominal pain	0/92 (0%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		1/76 (1.3%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Other (Not Including Serious) Adverse Events
	Core Period: LCI699 0.25 mg QD		Core Period: LCI699 0.5 mg QD		Core Period: LCI699 1.0 mg QD		Core Period: LCI699 0.5 mg BID		Core Period: Eplerenone 50 mg BID		Core Period: Placebo		Withdrawal Period: LCI699 0.25 mg QD		Withdrawal Period: LCI699 0.25 mg QD Placebo		Withdrawal Period: LCI699 0.5 mg QD		Withdrawal Period: LCI699 0.5 mg QD Placebo		Withdrawal Period: LCI699 1.0 mg QD		Withdrawal Period: LCI699 1.0 mg QD Placebo		Withdrawal Period: LCI699 0.5 mg BID		Withdrawal Period: LCI699 0.5 mg BID Placebo		Withdrawal Period: Eplerenone 50 mg BID		Withdrawal Period: Eplerenone 50 mg BID Placebo		Withdrawal Period: Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	22/92 (23.9%)		22/87 (25.3%)		24/87 (27.6%)		27/97 (27.8%)		26/84 (31%)		23/76 (30.3%)		2/46 (4.3%)		1/38 (2.6%)		1/44 (2.3%)		0/37 (0%)		3/41 (7.3%)		5/37 (13.5%)		4/45 (8.9%)		3/45 (6.7%)		2/39 (5.1%)		0/36 (0%)		3/66 (4.5%)
Cardiac disorders
Angina pectoris	0/92 (0%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		1/84 (1.2%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		1/45 (2.2%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Bradycardia	1/92 (1.1%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Palpitations	1/92 (1.1%)		1/87 (1.1%)		0/87 (0%)		0/97 (0%)		1/84 (1.2%)		2/76 (2.6%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Sinus bradycardia	0/92 (0%)		0/87 (0%)		1/87 (1.1%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Tachycardia	1/92 (1.1%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		1/45 (2.2%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Tachycardia paroxysmal	0/92 (0%)		0/87 (0%)		1/87 (1.1%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Congenital, familial and genetic disorders
Talipes	0/92 (0%)		0/87 (0%)		1/87 (1.1%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Ear and labyrinth disorders
Tinnitus	0/92 (0%)		0/87 (0%)		0/87 (0%)		1/97 (1%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Vestibular disorder	0/92 (0%)		0/87 (0%)		0/87 (0%)		1/97 (1%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Eye disorders
Conjunctivitis	0/92 (0%)		0/87 (0%)		0/87 (0%)		1/97 (1%)		0/84 (0%)		1/76 (1.3%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Glaucoma	1/92 (1.1%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Vision blurred	0/92 (0%)		1/87 (1.1%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Visual impairment	0/92 (0%)		0/87 (0%)		1/87 (1.1%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Gastrointestinal disorders
Abdominal pain	1/92 (1.1%)		0/87 (0%)		0/87 (0%)		1/97 (1%)		1/84 (1.2%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Abdominal pain lower	0/92 (0%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		1/37 (2.7%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Abdominal pain upper	0/92 (0%)		2/87 (2.3%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Constipation	0/92 (0%)		0/87 (0%)		0/87 (0%)		1/97 (1%)		1/84 (1.2%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Diarrhoea	2/92 (2.2%)		1/87 (1.1%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		2/76 (2.6%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Dry mouth	0/92 (0%)		0/87 (0%)		1/87 (1.1%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Dyspepsia	0/92 (0%)		0/87 (0%)		0/87 (0%)		1/97 (1%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Enterocolitis	0/92 (0%)		0/87 (0%)		1/87 (1.1%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Flatulence	0/92 (0%)		0/87 (0%)		1/87 (1.1%)		0/97 (0%)		1/84 (1.2%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Gastrointestinal haemorrhage	0/92 (0%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		1/76 (1.3%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Gingivitis	0/92 (0%)		0/87 (0%)		1/87 (1.1%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Hyperchlorhydria	0/92 (0%)		1/87 (1.1%)		0/87 (0%)		1/97 (1%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Nausea	1/92 (1.1%)		0/87 (0%)		1/87 (1.1%)		1/97 (1%)		0/84 (0%)		2/76 (2.6%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Oral pain	0/92 (0%)		0/87 (0%)		0/87 (0%)		1/97 (1%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Rectal haemorrhage	0/92 (0%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		1/84 (1.2%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Toothache	0/92 (0%)		0/87 (0%)		0/87 (0%)		1/97 (1%)		1/84 (1.2%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Vomiting	1/92 (1.1%)		0/87 (0%)		0/87 (0%)		1/97 (1%)		0/84 (0%)		2/76 (2.6%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
General disorders
Asthenia	0/92 (0%)		0/87 (0%)		0/87 (0%)		2/97 (2.1%)		1/84 (1.2%)		1/76 (1.3%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Chest discomfort	0/92 (0%)		0/87 (0%)		0/87 (0%)		1/97 (1%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Fatigue	1/92 (1.1%)		0/87 (0%)		1/87 (1.1%)		2/97 (2.1%)		0/84 (0%)		1/76 (1.3%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Irritability	1/92 (1.1%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Malaise	0/92 (0%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		1/76 (1.3%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Non-cardiac chest pain	2/92 (2.2%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Oedema peripheral	0/92 (0%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		1/76 (1.3%)		0/46 (0%)		1/38 (2.6%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Pyrexia	0/92 (0%)		1/87 (1.1%)		1/87 (1.1%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Hepatobiliary disorders
Biliary colic	0/92 (0%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		1/76 (1.3%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Hepatic function abnormal	0/92 (0%)		0/87 (0%)		0/87 (0%)		1/97 (1%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Hepatic steatosis	0/92 (0%)		0/87 (0%)		0/87 (0%)		1/97 (1%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Immune system disorders
Seasonal allergy	0/92 (0%)		0/87 (0%)		1/87 (1.1%)		0/97 (0%)		1/84 (1.2%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Infections and infestations
Acarodermatitis	0/92 (0%)		0/87 (0%)		0/87 (0%)		1/97 (1%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Acute tonsillitis	0/92 (0%)		1/87 (1.1%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Bronchitis	0/92 (0%)		1/87 (1.1%)		1/87 (1.1%)		0/97 (0%)		0/84 (0%)		1/76 (1.3%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Bronchitis bacterial	0/92 (0%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		1/84 (1.2%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Influenza	0/92 (0%)		2/87 (2.3%)		1/87 (1.1%)		1/97 (1%)		1/84 (1.2%)		1/76 (1.3%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Nasopharyngitis	1/92 (1.1%)		2/87 (2.3%)		3/87 (3.4%)		1/97 (1%)		4/84 (4.8%)		3/76 (3.9%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		1/45 (2.2%)		1/45 (2.2%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Pharyngitis	0/92 (0%)		1/87 (1.1%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Pneumonia	0/92 (0%)		1/87 (1.1%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Respiratory tract infection viral	0/92 (0%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		1/84 (1.2%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Rhinitis	1/92 (1.1%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Sialoadenitis	0/92 (0%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		1/66 (1.5%)
Sinusitis	0/92 (0%)		1/87 (1.1%)		2/87 (2.3%)		0/97 (0%)		1/84 (1.2%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Tooth abscess	0/92 (0%)		0/87 (0%)		0/87 (0%)		1/97 (1%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Tracheitis	0/92 (0%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		1/76 (1.3%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Tracheobronchitis	0/92 (0%)		1/87 (1.1%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Upper respiratory tract infection	1/92 (1.1%)		1/87 (1.1%)		1/87 (1.1%)		1/97 (1%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Urinary tract infection	2/92 (2.2%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		1/84 (1.2%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Viral infection	0/92 (0%)		0/87 (0%)		1/87 (1.1%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Injury, poisoning and procedural complications
Arthropod bite	0/92 (0%)		0/87 (0%)		1/87 (1.1%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Contusion	1/92 (1.1%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		1/76 (1.3%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		1/41 (2.4%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Joint sprain	2/92 (2.2%)		0/87 (0%)		1/87 (1.1%)		0/97 (0%)		0/84 (0%)		1/76 (1.3%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		1/37 (2.7%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Post procedural haematoma	0/92 (0%)		0/87 (0%)		1/87 (1.1%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Investigations
Weight decreased	0/92 (0%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		1/84 (1.2%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Metabolism and nutrition disorders
Anorexia	1/92 (1.1%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Gout	0/92 (0%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		1/76 (1.3%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Hypercholesterolaemia	0/92 (0%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		1/84 (1.2%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Hyperkalaemia	1/92 (1.1%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		1/84 (1.2%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Hypertriglyceridaemia	0/92 (0%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		1/45 (2.2%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Increased appetite	0/92 (0%)		1/87 (1.1%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/92 (0%)		0/87 (0%)		0/87 (0%)		1/97 (1%)		1/84 (1.2%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		1/39 (2.6%)		0/36 (0%)		0/66 (0%)
Arthritis	0/92 (0%)		0/87 (0%)		1/87 (1.1%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Back pain	1/92 (1.1%)		0/87 (0%)		1/87 (1.1%)		1/97 (1%)		1/84 (1.2%)		2/76 (2.6%)		1/46 (2.2%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		1/39 (2.6%)		0/36 (0%)		0/66 (0%)
Bursitis	1/92 (1.1%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		1/84 (1.2%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Foot deformity	0/92 (0%)		0/87 (0%)		1/87 (1.1%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Muscle spasms	0/92 (0%)		0/87 (0%)		1/87 (1.1%)		1/97 (1%)		1/84 (1.2%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Myalgia	0/92 (0%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		1/84 (1.2%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		1/37 (2.7%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Neck pain	0/92 (0%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		1/66 (1.5%)
Osteoarthritis	0/92 (0%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		1/84 (1.2%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Pain in extremity	0/92 (0%)		0/87 (0%)		0/87 (0%)		1/97 (1%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Periarthritis	0/92 (0%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		1/76 (1.3%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Polyarthritis	1/92 (1.1%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Spinal disorder	0/92 (0%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		1/45 (2.2%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Systemic lupus erythematosus	0/92 (0%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		1/84 (1.2%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Tenosynovitis	0/92 (0%)		0/87 (0%)		0/87 (0%)		1/97 (1%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm	0/92 (0%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		1/84 (1.2%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Nervous system disorders
Carotid arteriosclerosis	0/92 (0%)		0/87 (0%)		1/87 (1.1%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Carpal tunnel syndrome	1/92 (1.1%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Cervicobrachial syndrome	0/92 (0%)		0/87 (0%)		0/87 (0%)		1/97 (1%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		1/45 (2.2%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Complex regional pain syndrome	0/92 (0%)		1/87 (1.1%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Dizziness	0/92 (0%)		0/87 (0%)		2/87 (2.3%)		5/97 (5.2%)		1/84 (1.2%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Dizziness postural	0/92 (0%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		1/76 (1.3%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Headache	1/92 (1.1%)		4/87 (4.6%)		1/87 (1.1%)		2/97 (2.1%)		3/84 (3.6%)		10/76 (13.2%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		1/37 (2.7%)		0/45 (0%)		1/45 (2.2%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Migraine	1/92 (1.1%)		0/87 (0%)		0/87 (0%)		1/97 (1%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Paraesthesia	0/92 (0%)		1/87 (1.1%)		0/87 (0%)		0/97 (0%)		1/84 (1.2%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Somnolence	0/92 (0%)		1/87 (1.1%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Syncope	0/92 (0%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		1/37 (2.7%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Trigeminal neuralgia	0/92 (0%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		1/66 (1.5%)
Psychiatric disorders
Anxiety	1/92 (1.1%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Depression	0/92 (0%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		1/84 (1.2%)		1/76 (1.3%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Insomnia	0/92 (0%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		2/76 (2.6%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Stress	0/92 (0%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		1/84 (1.2%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Renal and urinary disorders
Nocturia	0/92 (0%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		1/84 (1.2%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Urinary incontinence	0/92 (0%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		1/46 (2.2%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Reproductive system and breast disorders
Ejaculation disorder	0/92 (0%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		1/84 (1.2%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Menopausal symptoms	0/92 (0%)		0/87 (0%)		1/87 (1.1%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	0/92 (0%)		1/87 (1.1%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		1/41 (2.4%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Epistaxis	0/92 (0%)		1/87 (1.1%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		1/38 (2.6%)		0/44 (0%)		0/37 (0%)		1/41 (2.4%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Haemoptysis	0/92 (0%)		1/87 (1.1%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Nasal congestion	0/92 (0%)		0/87 (0%)		0/87 (0%)		1/97 (1%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Oropharyngeal pain	1/92 (1.1%)		0/87 (0%)		1/87 (1.1%)		0/97 (0%)		2/84 (2.4%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		1/45 (2.2%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Paranasal sinus hypersecretion	0/92 (0%)		1/87 (1.1%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Rhinitis allergic	0/92 (0%)		0/87 (0%)		1/87 (1.1%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Rhinorrhoea	0/92 (0%)		1/87 (1.1%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		1/76 (1.3%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Wheezing	0/92 (0%)		0/87 (0%)		0/87 (0%)		1/97 (1%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Skin and subcutaneous tissue disorders
Angioedema	0/92 (0%)		1/87 (1.1%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Dermatitis	0/92 (0%)		0/87 (0%)		1/87 (1.1%)		0/97 (0%)		0/84 (0%)		1/76 (1.3%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Eczema	0/92 (0%)		1/87 (1.1%)		1/87 (1.1%)		0/97 (0%)		1/84 (1.2%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Erythema	1/92 (1.1%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		1/84 (1.2%)		1/76 (1.3%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Hyperhidrosis	0/92 (0%)		0/87 (0%)		1/87 (1.1%)		1/97 (1%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Rash	0/92 (0%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		1/44 (2.3%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Skin odour abnormal	0/92 (0%)		1/87 (1.1%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Skin striae	1/92 (1.1%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Urticaria	0/92 (0%)		1/87 (1.1%)		0/87 (0%)		1/97 (1%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Vascular disorders
Hypertensive crisis	1/92 (1.1%)		0/87 (0%)		0/87 (0%)		0/97 (0%)		0/84 (0%)		1/76 (1.3%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)
Raynaud's phenomenon	0/92 (0%)		0/87 (0%)		0/87 (0%)		1/97 (1%)		0/84 (0%)		0/76 (0%)		0/46 (0%)		0/38 (0%)		0/44 (0%)		0/37 (0%)		0/41 (0%)		0/37 (0%)		0/45 (0%)		0/45 (0%)		0/39 (0%)		0/36 (0%)		0/66 (0%)

Limitations/Caveats

[Not Specified]

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Principal Investigators are NOT employed by the organization sponsoring the study.

Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.

Results Point of Contact

Name/Title	Study Director
Organization	Novartis Pharmaceuticals
Phone	8627788300
Email	Novartis.email@novartis.com

Responsible Party:

Novartis Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00758524

Other Study ID Numbers:

CLCI699A2201

First Posted:

Sep 25, 2008

Last Update Posted:

Jul 6, 2021

Last Verified:

Jun 1, 2021

A Study to Evaluate Efficacy and Safety of LCI699 in Participants With Essential Hypertension

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Outcome Measure Data

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