Multiple Dose Pharmacokinetics of LCZ696 and Its Metabolites in Subjects With Severe Renal Impairment vs. Matched Healthy Subjects With Normal Renal Function
Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01569828
Collaborator
(none)
12
3
2
6
4
0.7
Study Details
Study Description
Brief Summary
An open label, parallel-group study to determine multiple dose pharmacokinetics of LCZ696 and its metabolites in subjects with severe renal impairment compared to matched healthy subjects with normal renal function
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
12 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open Label, Parallel-group Study to Determine Multiple Dose Pharmacokinetics of LCZ696 and Its Metabolites in Subjects With Severe Renal Impairment Compared to Matched Healthy Subjects With Normal Renal Function
Study Start Date
:
Mar 1, 2009
Actual Primary Completion Date
:
Sep 1, 2009
Actual Study Completion Date
:
Sep 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Renal Impaired Subjects once daily administration of 400 mg LCZ696 for 5 days |
Drug: LCZ696A
|
| Experimental: Healthy Volunteers once daily administration of 400 mg LCZ696 for 5 days |
Drug: LCZ696A
once daily administration of 400 mg LCZ696 for 5 days
|
Outcome Measures
Primary Outcome Measures
- Time to Reach Maximum Peak Plasma Concentration (Tmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5) [1 and 5 days]
- (Cmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5) [1 and 5 days]
- AUC 0-24h After Single Dose (Day 1), and After Multiple Dose Administration (Day 5) [1 and 5 days]
- T1/2 After Multiple Dose Administration (Day 5) [5 days]
Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696
- CL/F After Multiple Dose Administration (Day 5) [5 days]
Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696
- CLr After Multiple Dose Administration (Day 5) [5 days]
Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696
Secondary Outcome Measures
- 24 hr Sodium Urinary Excretion in Subjects With Severe Renal Impairment and Their Matched Healthy Volunteers [5 days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novartis Investigative Site | Neuss | Germany | 41460 | |
| 2 | Novartis Investigative Site | Moscow | Russian Federation | 117292 | |
| 3 | Novartis Investigative Site | Belgrade | Serbia |
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:
NCT01569828
Other Study ID Numbers:
- CLCZ696A2205
- 2007-005482-36
First Posted:
Apr 3, 2012
Last Update Posted:
Sep 29, 2015
Last Verified:
Aug 1, 2015
Keywords provided by Novartis Pharmaceuticals
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Severe Renal Impaired Subjects | Matched Healthy Volunteers |
|---|---|---|
| Arm/Group Description | Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days | All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min.Once daily administration of 400 mg LCZ696 p.o. for 5 days |
| Period Title: Overall Study | ||
| STARTED | 6 | 6 |
| COMPLETED | 6 | 6 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Severe Renal Impaired Subjects | Matched Healthy Volunteers | Total |
|---|---|---|---|
| Arm/Group Description | Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days | All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days | Total of all reporting groups |
| Overall Participants | 6 | 6 | 12 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
53.8
(7.76)
|
52.5
(6.98)
|
53.2
(7.07)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
3
50%
|
3
50%
|
6
50%
|
| Male |
3
50%
|
3
50%
|
6
50%
|
Outcome Measures
| Title | Time to Reach Maximum Peak Plasma Concentration (Tmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5) |
|---|---|
| Description | |
| Time Frame | 1 and 5 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic analysis set |
| Arm/Group Title | Renal Impaired Subjects | Healthy Volunteers |
|---|---|---|
| Arm/Group Description | Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days | All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days |
| Measure Participants | 6 | 6 |
| AHU377 (Sacubitril) on day 1 |
0.5
|
0.5
|
| AHU377 (Sacubitril) on day 5 |
0.5
|
0.5
|
| LBQ657(Sacubitril pro-drug) on day 1 |
3
|
3
|
| LBQ657(Sacubitril pro-drug) on day 5 |
2
|
2.5
|
| VAL489 (valsartan) on day 1 |
2
|
2
|
| VAL489 (valsartan) on day 5 |
2
|
2
|
| Title | 24 hr Sodium Urinary Excretion in Subjects With Severe Renal Impairment and Their Matched Healthy Volunteers |
|---|---|
| Description | |
| Time Frame | 5 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Renal Impaired Subjects | Healthy Volunteers |
|---|---|---|
| Arm/Group Description | Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days | All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days |
| Measure Participants | 6 | 6 |
| baseline |
172.658
(79.9239)
|
177.833
(39.5533)
|
| Day 1 |
133.000
(35.5564)
|
187.000
(42.8392)
|
| Day 2 |
89.333
(34.5714)
|
156.833
(26.4607)
|
| Day 3 |
106.050
(39.6424)
|
145.500
(31.5325)
|
| Day 4 |
94.683
(21.3792)
|
140.500
(30.9629)
|
| Day 5 |
93.500
(36.2171)
|
156.667
(32.1165)
|
| Day 6 |
88.400
(23.1383)
|
96.167
(28.6316)
|
| Day 7 |
107.150
(36.1899)
|
107.667
(57.4514)
|
| Title | (Cmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5) |
|---|---|
| Description | |
| Time Frame | 1 and 5 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic analysis set |
| Arm/Group Title | Renal Impaired Subjects | Healthy Volunteers |
|---|---|---|
| Arm/Group Description | Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days | All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days |
| Measure Participants | 6 | 6 |
| AHU377 (Sacubitril)on day 1 |
5215
(3220)
|
2810
(862)
|
| AHU377(Sacubitril) on day 5 |
4960
(3430)
|
2407
(1780)
|
| LBQ657 (Sacubitril prodrug)on day 1 |
15967
(3380)
|
14633
(2233)
|
| LBQ657 ( Sacubitril prodrug) on day 5 |
30650
(11462)
|
18233
(1975)
|
| VAL489 (valsartan) on day 1 |
5935
(2191)
|
4988
(1093)
|
| VAL489 (valsartan) on day 5 |
5852
(3306)
|
5672
(1314)
|
| Title | AUC 0-24h After Single Dose (Day 1), and After Multiple Dose Administration (Day 5) |
|---|---|
| Description | |
| Time Frame | 1 and 5 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic analysis set |
| Arm/Group Title | Renal Impaired Subjects | Healthy Volunteers |
|---|---|---|
| Arm/Group Description | Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days | All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days |
| Measure Participants | 6 | 6 |
| AHU377 (Sacubitril) on day 1 |
5918
(3430.4)
|
4101
(815.36)
|
| AHU377(Sacubitril) on day 5 |
5495
(2890.2)
|
4336
(745.88)
|
| LBQ657(Sacubitril prodrug) on day 1 |
254000
(72562)
|
146100
(17346)
|
| LBQ657 (Sacubitril prodrug) on day 5 |
538300
(268650)
|
185500
(29759)
|
| VAL489 (valsartan) on day 1 |
40560
(11344)
|
29870
(8756.9)
|
| VAL489 (valsartan) on day 5 |
51080
(33780)
|
32470
(8687.1)
|
| Title | T1/2 After Multiple Dose Administration (Day 5) |
|---|---|
| Description | Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696 |
| Time Frame | 5 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic analysis set |
| Arm/Group Title | Renal Impaired Subjects | Healthy Volunteers |
|---|---|---|
| Arm/Group Description | Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days | All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days |
| Measure Participants | 6 | 6 |
| AHU377 (Sacubitril)on day 5 |
2.030
(1.2793)
|
1.916
(0.69234)
|
| LBQ657(Sacubitril prodrug) on day 5 |
38.55
(17.301)
|
13.16
(2.6829)
|
| VAL489 (valsartan) on day 5 |
26.40
(9.1992)
|
12.98
(2.9882)
|
| Title | CL/F After Multiple Dose Administration (Day 5) |
|---|---|
| Description | Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696 |
| Time Frame | 5 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic analysis set |
| Arm/Group Title | Renal Impaired Subjects | Healthy Volunteers |
|---|---|---|
| Arm/Group Description | Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days | All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days |
| Measure Participants | 6 | 6 |
| AHU377(Sacubitril) on day 5 |
45100
(24523)
|
45900
(8168.0)
|
| LBQ657( Sacubitril prodrug) on day 5 |
NA
(NA)
|
NA
(NA)
|
| VAL489 (valsartan) on day 5 |
7370
(8063.0)
|
6792
(2051.1)
|
| Title | CLr After Multiple Dose Administration (Day 5) |
|---|---|
| Description | Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696 |
| Time Frame | 5 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic analysis set |
| Arm/Group Title | Renal Impaired Subjects | Healthy Volunteers |
|---|---|---|
| Arm/Group Description | Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement.Once daily administration of 400 mg LCZ696 p.o. for 5 days | All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days |
| Measure Participants | 6 | 6 |
| AHU377 (Sacubitril) on day 5 |
24.18
(28.781)
|
111.8
(82.310)
|
| LBQ657 (Sacubitril prodrug) on day 5 |
47.39
(38.392)
|
436.9
(72.388)
|
| VAL489 (valsartan) on day 5 |
28.89
(20.781)
|
299.4
(97.887)
|
Adverse Events
| Time Frame | Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment (FSFT) until Last Subject Last Visit (LSLV). | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Severe Renal Impaired Patients | Matched Healthy Volunteers | ||
| Arm/Group Description | ||||
All Cause Mortality |
||||
| Severe Renal Impaired Patients | Matched Healthy Volunteers | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Severe Renal Impaired Patients | Matched Healthy Volunteers | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/6 (0%) | 0/6 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Severe Renal Impaired Patients | Matched Healthy Volunteers | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/6 (100%) | 5/6 (83.3%) | ||
| Cardiac disorders | ||||
| Postural orthostatic tachycardia syndrome | 3/6 (50%) | 0/6 (0%) | ||
| Sinus bradycardia | 1/6 (16.7%) | 0/6 (0%) | ||
| Ear and labyrinth disorders | ||||
| Vertigo | 0/6 (0%) | 1/6 (16.7%) | ||
| Gastrointestinal disorders | ||||
| Diarrhoea | 0/6 (0%) | 1/6 (16.7%) | ||
| Flatulence | 0/6 (0%) | 1/6 (16.7%) | ||
| General disorders | ||||
| Fatigue | 0/6 (0%) | 1/6 (16.7%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Myalgia | 0/6 (0%) | 2/6 (33.3%) | ||
| Nervous system disorders | ||||
| Somnolence | 0/6 (0%) | 1/6 (16.7%) | ||
| Vascular disorders | ||||
| Diastolic hypertension | 1/6 (16.7%) | 0/6 (0%) | ||
| Orthostatic hypertension | 3/6 (50%) | 0/6 (0%) | ||
| Orthostatic hypotension | 3/6 (50%) | 0/6 (0%) | ||
| Systolic hypertension | 1/6 (16.7%) | 0/6 (0%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The terms and conditions of Novartis' agreements with its investigators may vary. However, 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 | 862-778-8300 |
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01569828
Other Study ID Numbers:
- CLCZ696A2205
- 2007-005482-36
First Posted:
Apr 3, 2012
Last Update Posted:
Sep 29, 2015
Last Verified:
Aug 1, 2015