Clincosm LogoSign in Get a demo

A Study of LY2623091 in Participants With High Blood Pressure

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT02194465
Collaborator
(none)
304
Enrollment
43
Locations
7
Arms
7
Duration (Months)
7.1
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of this study is to evaluate the safety and effectiveness of the study drug known as LY2623091 in participants with high blood pressure.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
304 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Placebo-Controlled, Double-Blinded, Parallel, Phase 2a Study to Evaluate the Safety and Efficacy of LY2623091 in Patients With Primary Hypertension
Study Start Date :
Aug 1, 2014
Actual Primary Completion Date :
Mar 1, 2015
Actual Study Completion Date :
Mar 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: 6 milligrams (mg) LY2623091

6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.

Drug: LY2623091
Administered orally
Other Names:
  • Mineralocorticoid Receptor Antagonist

    • Drug: Placebo
    Administered orally
    Experimental: 13 mg LY2623091

    13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.

    Drug: LY2623091
    Administered orally
    Other Names:
  • Mineralocorticoid Receptor Antagonist

    • Drug: Placebo
    Administered orally
    Experimental: 24.5 mg LY2623091

    24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.

    Drug: LY2623091
    Administered orally
    Other Names:
  • Mineralocorticoid Receptor Antagonist

    • Drug: Placebo
    Administered orally
    Experimental: 13 mg LY2623091 + 20 mg tadalafil

    13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks.

    Drug: LY2623091
    Administered orally
    Other Names:
  • Mineralocorticoid Receptor Antagonist

    • Drug: Tadalafil
    Administered orally
    Other Names:
  • LY450190

    • Drug: Placebo
    Administered orally
    Experimental: 20 mg tadalafil

    20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks.

    Drug: Tadalafil
    Administered orally
    Other Names:
  • LY450190

    • Drug: Placebo
    Administered orally
    Active Comparator: Spironolactone

    25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.

    Drug: Spironolactone
    Administered orally
    Placebo Comparator: Placebo

    Placebo for blinding administered orally once daily for 4 weeks.

    Drug: Placebo
    Administered orally

    Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline to 4 Weeks in Seated Systolic Blood Pressure (SBP) [Baseline, 4 Weeks]

      Change from baseline in SBP as measured by a cuff. Least squares (LS) mean change from baseline was calculated using a mixed model repeating measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.

    Secondary Outcome Measures

    1. Change From Baseline to 4 Weeks in Seated Diastolic Blood Pressure (DBP) [Baseline, 4 Weeks]

      Change from baseline in DBP as measured by a cuff. LS mean change from baseline was calculated using a MMRM with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.

    2. Change From Baseline to 4 Weeks in 24 Hour Ambulatory Blood Pressure Monitoring (ABPM) [Baseline, 4 Weeks]

      The LS mean change in blood pressure is calculated after adjusting for baseline, treatment and race using an analysis of covariance (ANCOVA).

    3. Change From Baseline to 4 Weeks in Serum Potassium [Baseline, 4 Weeks]

      Potassium measurement as measured by standard laboratory tests. The LS mean change in potassium is calculated using MMRM with adjustment for baseline, treatment, visit, treatment*visit and race.

    4. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2623091 [2 hours post-dose at 4 Weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Have a history of hypertension.

    • If participants are naïve to treatment of hypertension, or have not been treated with any antihypertensive medications within the 30 days immediately prior to screening:

    • Have seated systolic (SBP) of ≥140 and <170 millimeters of mercury (mmHg) at screening and at the end of the lead-in period.

    • If participants are currently being treated for hypertension:

    • Are taking a stable dose of 1 or 2 antihypertensive medications for at least the previous 30 days. A combination antihypertensive medication from 2 classes is considered as 2 antihypertensive medications.

    • Are willing to discontinue the antihypertensive medications during the study.

    • Have seated SBP of ≥140 and <170 mmHg at the end of the lead-in period.

    • Have a body mass index (BMI) ≥18.5 and <40 kilograms/m^2.

    Exclusion Criteria:

    • Have a history of severe hypertension (defined as SBP ≥180 mmHg and/or diastolic (DBP) ≥120 mmHg), secondary hypertension, symptomatic postural hypotension, or hospitalization due to hypertension.

    • Have SBP ≥180 mmHg and/or DBP ≥110 mmHg at screening, lead-in period, or randomization.

    • Have a history of hospitalization due to hyperkalemia, or history of drug discontinuation due to elevated serum potassium levels.

    • Have a serum potassium ≤3.5 or >5.0 millimoles per liter (mmol/L).

    • Have an estimated glomerular filtration rate (eGFR) <50 milliliters/minute/1.73 m^2.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical Research Advantage Glendale Arizona United States 85306
    2 John Muir Health Network - The Osteoporosis Center Concord California United States 94520
    3 Encompass Clinical Research Encinitas California United States 92024
    4 Avail Clinical Research LLC DeLand Florida United States 32720
    5 Alan Graff, MD, PA Fort Lauderdale Florida United States 33308
    6 Jacksonville Center for Clinical Research Jacksonville Florida United States 32216
    7 Cardiovascular Center of Sarasota Sarasota Florida United States 34239
    8 East West Medical Institute Honolulu Hawaii United States 96814
    9 Rocky Mountain Diabetes and Osteoporosis Center Idaho Falls Idaho United States 83404
    10 Northwest Heart Clinical Research, LLC Arlington Heights Illinois United States 60005
    11 Cedar-Crosse Research Center Chicago Illinois United States 60607
    12 Midwest Institute for Clinical Research Indianapolis Indiana United States 46260
    13 Community Clinical Research Center Muncie Indiana United States 47304
    14 Heartland Research Associates Wichita Kansas United States 67207
    15 Grace Research Bossier City Louisiana United States 71111
    16 Maine Research Associates Auburn Maine United States 04210
    17 AB Clinical Trials Las Vegas Nevada United States 89119
    18 Rochester Clinical Research, Inc. Rochester New York United States 14609
    19 Metrolina Internal Medicine, P.A. Charlotte North Carolina United States 28204
    20 PharmQuest Greensboro North Carolina United States 27408
    21 Lillestol Research LLC Fargo North Dakota United States 58103
    22 Sterling Research Group, LTD Cincinnati Ohio United States 45219
    23 Rapid Medical Research Inc Cleveland Ohio United States 44122
    24 Columbus Clinical Research Columbus Ohio United States 43213
    25 Dayton Clinical Research Dayton Ohio United States 45406
    26 Cor Clinical Research LLC Oklahoma City Oklahoma United States 4052728481
    27 Oklahoma Foundation For Cardiovascular Research Oklahoma City Oklahoma United States 73120
    28 Mountain View Clinical Research, Inc Greer South Carolina United States 29651
    29 Texas Diabetes and Endocrinology Austin Texas United States 78731-4309
    30 Tekton Research, Inc Austin Texas United States 78745
    31 Texas Diabetes and Endocrinology, P.A. Round Rock Texas United States 78681
    32 Northwest Clinical Research Center Bellevue Washington United States 98007-4209
    33 Universal Research Group, LLC Tacoma Washington United States 98405
    34 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Brampton Canada L6T 0G1
    35 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kelowna Canada V1Y3G8
    36 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Peterborough Canada K9J 0B2
    37 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Pointe Claire Canada H9R 4S3
    38 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Quebec City Canada G1N 4V3
    39 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Red Deer Canada T4N 6V7
    40 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Sherbrooke Canada J1J 2G2
    41 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Toronto Canada M9W 4L6
    42 Research and Cardiovascular Corp. Ponce Puerto Rico 00717-1322
    43 Clinical Research Puerto Rico, Inc. San Juan Puerto Rico 00909

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT02194465
    Other Study ID Numbers:
    • 15525
    • I7T-MC-RMAH
    First Posted:
    Jul 18, 2014
    Last Update Posted:
    Jun 26, 2020
    Last Verified:
    Jun 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Hypertension
    Essential Hypertension
    Spironolactone
    Tadalafil
    Mineralocorticoid Receptor Antagonists
    Mineralocorticoids

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail Participants entered at lead-in for wash out and a placebo run-in period prior to randomization.
    Arm/Group Title Placebo 6 Milligrams (mg) LY2623091 13 mg LY2623091 24.5 mg LY2623091 13 mg LY2623091 + 20 mg Tadalafil 20 mg Tadalafil Spironolactone
    Arm/Group Description Placebo for blinding administered orally once daily for 4 weeks. 6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks. 13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks. 24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks. 13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks. 20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks. 25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.
    Period Title: Overall Study
    STARTED 51 50 52 49 51 25 26
    Received at Least 1 Dose of Study Drug 51 50 51 49 51 25 26
    COMPLETED 42 43 44 41 42 21 24
    NOT COMPLETED 9 7 8 8 9 4 2

    Baseline Characteristics

    Arm/Group Title Placebo 6 mg LY2623091 13 mg LY2623091 24.5 mg LY2623091 13 mg LY2623091 + 20 mg Tadalafil 20 mg Tadalafil Spironolactone Total
    Arm/Group Description Placebo for blinding administered orally once daily for 4 weeks. 6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks. 13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks. 24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks. 13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks. 20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks. 25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks. Total of all reporting groups
    Overall Participants 51 50 51 49 51 25 26 303
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    58.6
    (9.4)
    56.6
    (11.4)
    58.0
    (8.8)
    58.7
    (8.8)
    57.9
    (9.5)
    54.0
    (8.9)
    59.0
    (11.0)
    57.7
    (9.7)
    Sex: Female, Male (Count of Participants)
    Female
    16
    31.4%
    17
    34%
    24
    47.1%
    20
    40.8%
    21
    41.2%
    8
    32%
    7
    26.9%
    113
    37.3%
    Male
    35
    68.6%
    33
    66%
    27
    52.9%
    29
    59.2%
    30
    58.8%
    17
    68%
    19
    73.1%
    190
    62.7%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    2
    3.9%
    5
    10%
    2
    3.9%
    2
    4.1%
    4
    7.8%
    4
    16%
    1
    3.8%
    20
    6.6%
    Not Hispanic or Latino
    42
    82.4%
    39
    78%
    45
    88.2%
    39
    79.6%
    43
    84.3%
    19
    76%
    23
    88.5%
    250
    82.5%
    Unknown or Not Reported
    7
    13.7%
    6
    12%
    4
    7.8%
    8
    16.3%
    4
    7.8%
    2
    8%
    2
    7.7%
    33
    10.9%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    1
    2%
    0
    0%
    1
    2%
    2
    4.1%
    1
    2%
    0
    0%
    0
    0%
    5
    1.7%
    Asian
    7
    13.7%
    4
    8%
    2
    3.9%
    6
    12.2%
    2
    3.9%
    2
    8%
    3
    11.5%
    26
    8.6%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    13
    25.5%
    15
    30%
    14
    27.5%
    12
    24.5%
    13
    25.5%
    7
    28%
    6
    23.1%
    80
    26.4%
    White
    28
    54.9%
    30
    60%
    34
    66.7%
    29
    59.2%
    35
    68.6%
    15
    60%
    16
    61.5%
    187
    61.7%
    More than one race
    2
    3.9%
    1
    2%
    0
    0%
    0
    0%
    0
    0%
    1
    4%
    1
    3.8%
    5
    1.7%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (Count of Participants)
    Canada
    18
    35.3%
    12
    24%
    9
    17.6%
    13
    26.5%
    13
    25.5%
    5
    20%
    4
    15.4%
    74
    24.4%
    United States
    32
    62.7%
    36
    72%
    41
    80.4%
    35
    71.4%
    38
    74.5%
    19
    76%
    21
    80.8%
    222
    73.3%
    Puerto Rico
    1
    2%
    2
    4%
    1
    2%
    1
    2%
    0
    0%
    1
    4%
    1
    3.8%
    7
    2.3%
    BMI (kilogram/square meter (kg/m2)) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kilogram/square meter (kg/m2)]
    30.5
    (4.5)
    30.2
    (5.2)
    30.2
    (4.9)
    32.7
    (4.5)
    29.5
    (4.7)
    29.6
    (4.2)
    31.4
    (4.5)
    30.6
    (4.8)
    Chronic Kidney Disease (CKD) (Count of Participants)
    Y
    0
    0%
    3
    6%
    2
    3.9%
    0
    0%
    0
    0%
    2
    8%
    2
    7.7%
    9
    3%
    N
    51
    100%
    47
    94%
    49
    96.1%
    49
    100%
    51
    100%
    23
    92%
    24
    92.3%
    294
    97%
    Anti-Hypertensive Medication (Count of Participants)
    0
    8
    15.7%
    10
    20%
    5
    9.8%
    7
    14.3%
    13
    25.5%
    6
    24%
    3
    11.5%
    52
    17.2%
    1
    24
    47.1%
    22
    44%
    25
    49%
    22
    44.9%
    17
    33.3%
    10
    40%
    10
    38.5%
    130
    42.9%
    2
    19
    37.3%
    17
    34%
    20
    39.2%
    19
    38.8%
    20
    39.2%
    8
    32%
    13
    50%
    116
    38.3%
    3
    0
    0%
    1
    2%
    1
    2%
    0
    0%
    1
    2%
    1
    4%
    0
    0%
    4
    1.3%
    4
    0
    0%
    0
    0%
    0
    0%
    1
    2%
    0
    0%
    0
    0%
    0
    0%
    1
    0.3%
    Diabetes (Count of Participants)
    Y
    10
    19.6%
    6
    12%
    11
    21.6%
    9
    18.4%
    5
    9.8%
    6
    24%
    4
    15.4%
    51
    16.8%
    N
    41
    80.4%
    44
    88%
    40
    78.4%
    40
    81.6%
    46
    90.2%
    19
    76%
    22
    84.6%
    252
    83.2%
    Baseline in Seated Systolic Blood Pressure (SBP) (millimeter of mercury (mmHg)) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [millimeter of mercury (mmHg)]
    151.2
    (8.8)
    150.8
    (8.6)
    153.7
    (8.3)
    150.7
    (10.2)
    152.1
    (9.6)
    151.7
    (9.6)
    153.4
    (9.0)
    151.9
    (9.1)
    Baseline in Seated Diastolic Blood Pressure (DBP) (millimeter of mercury (mmHg)) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [millimeter of mercury (mmHg)]
    89.8
    (8.8)
    88.2
    (9.7)
    90.5
    (9.5)
    88.5
    (8.5)
    90.6
    (8.9)
    91.5
    (8.8)
    88.6
    (11.6)
    89.6
    (9.3)

    Outcome Measures

    1. Primary Outcome
    Title Change From Baseline to 4 Weeks in Seated Systolic Blood Pressure (SBP)
    Description Change from baseline in SBP as measured by a cuff. Least squares (LS) mean change from baseline was calculated using a mixed model repeating measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
    Time Frame Baseline, 4 Weeks

    Outcome Measure Data

    Analysis Population Description
    All randomized participants receiving at least 1 dose of the study drug and had baseline and post baseline evaluable data for SBP.
    Arm/Group Title Placebo 6 mg LY2623091 13 mg LY2623091 24.5 mg LY2623091 13 mg LY2623091 + 20 mg Tadalafil 20 mg Tadalafil Spironolactone
    Arm/Group Description Placebo for blinding administered orally once daily for 4 weeks. 6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks. 13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks. 24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks. 13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks. 20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks. 25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.
    Measure Participants 41 45 43 41 43 21 23
    Least Squares Mean (Standard Error) [millimeter of mercury (mmHg)]
    -0.5
    (11.6)
    -13.1
    (11.2)
    -14.6
    (12.3)
    -14.3
    (13.6)
    -11.8
    (12.5)
    -7.1
    (13.3)
    -15.4
    (11.7)
    2. Secondary Outcome
    Title Change From Baseline to 4 Weeks in Seated Diastolic Blood Pressure (DBP)
    Description Change from baseline in DBP as measured by a cuff. LS mean change from baseline was calculated using a MMRM with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
    Time Frame Baseline, 4 Weeks

    Outcome Measure Data

    Analysis Population Description
    All randomized participants receiving at least 1 dose of the study drug and had baseline and post baseline evaluable data for DBP.
    Arm/Group Title Placebo 6 mg LY2623091 13 mg LY2623091 24.5 mg LY2623091 13 mg LY2623091 + 20 mg Tadalafil 20 mg Tadalafil Spironolactone
    Arm/Group Description Placebo for blinding administered orally once daily for 4 weeks. 6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks. 13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks. 24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks. 13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks. 20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks. 25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.
    Measure Participants 41 45 43 41 43 21 23
    Least Squares Mean (Standard Error) [mmHg]
    0.5
    (7.9)
    -5.6
    (9.2)
    -4.8
    (7.2)
    -7.1
    (7.6)
    -6.8
    (8.7)
    -6.6
    (8.7)
    -1.2
    (6.1)
    3. Secondary Outcome
    Title Change From Baseline to 4 Weeks in 24 Hour Ambulatory Blood Pressure Monitoring (ABPM)
    Description The LS mean change in blood pressure is calculated after adjusting for baseline, treatment and race using an analysis of covariance (ANCOVA).
    Time Frame Baseline, 4 Weeks

    Outcome Measure Data

    Analysis Population Description
    All randomized participants receiving at least 1 dose of the study drug and had evaluable data for 24 hour ABPM.
    Arm/Group Title Placebo 6 mg LY2623091 13 mg LY2623091 24.5 mg LY2623091 13 mg LY2623091 + 20 mg Tadalafil 20 mg Tadalafil Spironolactone
    Arm/Group Description Placebo for blinding administered orally once daily for 4 weeks. 6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks. 13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks. 24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks. 13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks. 20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks. 25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.
    Measure Participants 37 37 39 33 36 19 22
    SBP
    0.3
    (11.3)
    -4.9
    (8.7)
    -11.1
    (8.9)
    -10.4
    (11.4)
    -10.4
    (11.6)
    -6.3
    (8.9)
    -6.4
    (6.8)
    DBP
    1.0
    (7.7)
    -1.7
    (6.3)
    -4.7
    (6.1)
    -3.4
    (4.8)
    -6.2
    (8.0)
    -5.6
    (4.9)
    -2.0
    (4.6)
    4. Secondary Outcome
    Title Change From Baseline to 4 Weeks in Serum Potassium
    Description Potassium measurement as measured by standard laboratory tests. The LS mean change in potassium is calculated using MMRM with adjustment for baseline, treatment, visit, treatment*visit and race.
    Time Frame Baseline, 4 Weeks

    Outcome Measure Data

    Analysis Population Description
    All randomized participants receiving at least 1 dose of the study drug and had evaluable data for serum potassium.
    Arm/Group Title Placebo 6 mg LY2623091 13 mg LY2623091 24.5 mg LY2623091 13 mg LY2623091 + 20 mg Tadalafil 20 mg Tadalafil Spironolactone
    Arm/Group Description Placebo for blinding administered orally once daily for 4 weeks. 6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks. 13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks. 24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks. 13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks. 20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks. 25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.
    Measure Participants 42 45 43 41 44 21 24
    Least Squares Mean (Standard Error) [millimoles/L (mmol/L)]
    -0.04
    (0.06)
    0.10
    (0.06)
    0.11
    (0.06)
    0.25
    (0.06)
    0.10
    (0.06)
    -0.06
    (0.08)
    0.30
    (0.08)
    5. Secondary Outcome
    Title Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2623091
    Description
    Time Frame 2 hours post-dose at 4 Weeks

    Outcome Measure Data

    Analysis Population Description
    All participants who had evaluable PK data of LY2623091.
    Arm/Group Title 6 mg LY2623091 13 mg LY2623091 24.5 mg LY2623091 13 mg LY2623091 + 20 mg Tadalafil
    Arm/Group Description 6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks. 13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks. 24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks. 13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks.
    Measure Participants 41 40 36 39
    Geometric Mean (Geometric Coefficient of Variation) [nanogram/milliliter (ng/ml)]
    122
    (32)
    228
    (37)
    379
    (51)
    206
    (53)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
    Arm/Group Title Placebo 6 mg LY2623091 13 mg LY2623091 24.5 mg LY2623091 13 mg LY2623091 + 20 mg Tadalafil 20 mg Tadalafil Spironolactone
    Arm/Group Description Placebo for blinding administered orally once daily for 4 weeks. 6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks. 13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks. 24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks. 13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks. 20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks. 25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.
    All Cause Mortality
    Placebo 6 mg LY2623091 13 mg LY2623091 24.5 mg LY2623091 13 mg LY2623091 + 20 mg Tadalafil 20 mg Tadalafil Spironolactone
    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 / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Placebo 6 mg LY2623091 13 mg LY2623091 24.5 mg LY2623091 13 mg LY2623091 + 20 mg Tadalafil 20 mg Tadalafil Spironolactone
    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 0/51 (0%) 0/50 (0%) 2/51 (3.9%) 0/49 (0%) 1/51 (2%) 0/25 (0%) 0/26 (0%)
    Gastrointestinal disorders
    Inguinal hernia 0/51 (0%) 0 0/50 (0%) 0 0/51 (0%) 0 0/49 (0%) 0 1/51 (2%) 1 0/25 (0%) 0 0/26 (0%) 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion 0/51 (0%) 0 0/50 (0%) 0 1/51 (2%) 1 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Skin and subcutaneous tissue disorders
    Diabetic foot 0/51 (0%) 0 0/50 (0%) 0 1/51 (2%) 1 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Other (Not Including Serious) Adverse Events
    Placebo 6 mg LY2623091 13 mg LY2623091 24.5 mg LY2623091 13 mg LY2623091 + 20 mg Tadalafil 20 mg Tadalafil Spironolactone
    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 23/51 (45.1%) 23/50 (46%) 21/51 (41.2%) 18/49 (36.7%) 34/51 (66.7%) 14/25 (56%) 12/26 (46.2%)
    Blood and lymphatic system disorders
    Leukocytosis 0/51 (0%) 0 0/50 (0%) 0 0/51 (0%) 0 1/49 (2%) 1 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Neutrophilia 0/51 (0%) 0 0/50 (0%) 0 0/51 (0%) 0 1/49 (2%) 1 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Cardiac disorders
    Bundle branch block right 0/51 (0%) 0 1/50 (2%) 1 0/51 (0%) 0 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Tachycardia 0/51 (0%) 0 0/50 (0%) 0 0/51 (0%) 0 2/49 (4.1%) 2 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Ventricular extrasystoles 0/51 (0%) 0 0/50 (0%) 0 1/51 (2%) 1 0/49 (0%) 0 0/51 (0%) 0 1/25 (4%) 1 1/26 (3.8%) 1
    Ear and labyrinth disorders
    Tinnitus 1/51 (2%) 1 0/50 (0%) 0 0/51 (0%) 0 1/49 (2%) 1 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Vertigo 0/51 (0%) 0 0/50 (0%) 0 0/51 (0%) 0 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 1/26 (3.8%) 1
    Endocrine disorders
    Hypothyroidism 0/51 (0%) 0 0/50 (0%) 0 1/51 (2%) 1 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Eye disorders
    Eyelid oedema 0/51 (0%) 0 1/50 (2%) 1 0/51 (0%) 0 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Scleral haemorrhage 0/51 (0%) 0 1/50 (2%) 1 0/51 (0%) 0 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Visual impairment 0/51 (0%) 0 1/50 (2%) 1 0/51 (0%) 0 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Gastrointestinal disorders
    Abdominal discomfort 0/51 (0%) 0 1/50 (2%) 1 0/51 (0%) 0 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Abdominal distension 0/51 (0%) 0 0/50 (0%) 0 1/51 (2%) 1 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Constipation 0/51 (0%) 0 0/50 (0%) 0 0/51 (0%) 0 0/49 (0%) 0 1/51 (2%) 1 0/25 (0%) 0 0/26 (0%) 0
    Dental caries 0/51 (0%) 0 0/50 (0%) 0 0/51 (0%) 0 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 1/26 (3.8%) 1
    Diarrhoea 1/51 (2%) 1 1/50 (2%) 1 1/51 (2%) 1 0/49 (0%) 0 3/51 (5.9%) 3 0/25 (0%) 0 1/26 (3.8%) 1
    Diverticulum 0/51 (0%) 0 0/50 (0%) 0 1/51 (2%) 1 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Diverticulum intestinal 0/51 (0%) 0 0/50 (0%) 0 1/51 (2%) 1 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Dry mouth 1/51 (2%) 1 0/50 (0%) 0 0/51 (0%) 0 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Dyspepsia 0/51 (0%) 0 0/50 (0%) 0 1/51 (2%) 1 1/49 (2%) 1 1/51 (2%) 1 2/25 (8%) 2 0/26 (0%) 0
    Dysphagia 0/51 (0%) 0 0/50 (0%) 0 0/51 (0%) 0 0/49 (0%) 0 0/51 (0%) 0 1/25 (4%) 1 0/26 (0%) 0
    Faecal incontinence 1/51 (2%) 1 0/50 (0%) 0 0/51 (0%) 0 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Faeces soft 1/51 (2%) 1 0/50 (0%) 0 0/51 (0%) 0 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Gastrooesophageal reflux disease 0/51 (0%) 0 0/50 (0%) 0 0/51 (0%) 0 0/49 (0%) 0 2/51 (3.9%) 2 0/25 (0%) 0 0/26 (0%) 0
    Lip swelling 0/51 (0%) 0 1/50 (2%) 1 0/51 (0%) 0 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Nausea 1/51 (2%) 1 0/50 (0%) 0 0/51 (0%) 0 2/49 (4.1%) 2 3/51 (5.9%) 3 0/25 (0%) 0 2/26 (7.7%) 2
    Toothache 0/51 (0%) 0 0/50 (0%) 0 0/51 (0%) 0 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 1/26 (3.8%) 1
    Vomiting 0/51 (0%) 0 1/50 (2%) 1 0/51 (0%) 0 0/49 (0%) 0 3/51 (5.9%) 3 0/25 (0%) 0 0/26 (0%) 0
    General disorders
    Chest discomfort 0/51 (0%) 0 1/50 (2%) 1 0/51 (0%) 0 0/49 (0%) 0 0/51 (0%) 0 1/25 (4%) 1 0/26 (0%) 0
    Fatigue 0/51 (0%) 0 0/50 (0%) 0 0/51 (0%) 0 1/49 (2%) 1 2/51 (3.9%) 2 0/25 (0%) 0 0/26 (0%) 0
    Feeling abnormal 0/51 (0%) 0 0/50 (0%) 0 1/51 (2%) 1 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Oedema peripheral 0/51 (0%) 0 0/50 (0%) 0 0/51 (0%) 0 0/49 (0%) 0 2/51 (3.9%) 2 0/25 (0%) 0 0/26 (0%) 0
    Pain 1/51 (2%) 1 0/50 (0%) 0 0/51 (0%) 0 0/49 (0%) 0 2/51 (3.9%) 2 1/25 (4%) 1 0/26 (0%) 0
    Peripheral swelling 1/51 (2%) 1 0/50 (0%) 0 1/51 (2%) 1 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Hepatobiliary disorders
    Hepatic steatosis 0/51 (0%) 0 1/50 (2%) 1 0/51 (0%) 0 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Non-alcoholic steatohepatitis 0/51 (0%) 0 0/50 (0%) 0 1/51 (2%) 1 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Infections and infestations
    Bronchitis 0/51 (0%) 0 0/50 (0%) 0 0/51 (0%) 0 1/49 (2%) 1 0/51 (0%) 0 1/25 (4%) 1 0/26 (0%) 0
    Bronchitis viral 0/51 (0%) 0 0/50 (0%) 0 0/51 (0%) 0 0/49 (0%) 0 1/51 (2%) 1 0/25 (0%) 0 1/26 (3.8%) 1
    Cellulitis 0/51 (0%) 0 1/50 (2%) 1 0/51 (0%) 0 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Conjunctivitis 0/51 (0%) 0 1/50 (2%) 1 0/51 (0%) 0 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Epididymitis 0/35 (0%) 0 0/33 (0%) 0 0/27 (0%) 0 0/29 (0%) 0 0/30 (0%) 0 1/17 (5.9%) 1 0/19 (0%) 0
    Gastroenteritis 0/51 (0%) 0 0/50 (0%) 0 0/51 (0%) 0 1/49 (2%) 1 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Joint abscess 0/51 (0%) 0 1/50 (2%) 1 0/51 (0%) 0 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Nasopharyngitis 1/51 (2%) 1 4/50 (8%) 4 2/51 (3.9%) 2 1/49 (2%) 1 1/51 (2%) 1 0/25 (0%) 0 0/26 (0%) 0
    Oral herpes 0/51 (0%) 0 1/50 (2%) 1 0/51 (0%) 0 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Sinusitis 0/51 (0%) 0 0/50 (0%) 0 0/51 (0%) 0 1/49 (2%) 1 1/51 (2%) 1 0/25 (0%) 0 0/26 (0%) 0
    Tooth abscess 0/51 (0%) 0 0/50 (0%) 0 0/51 (0%) 0 0/49 (0%) 0 1/51 (2%) 1 0/25 (0%) 0 0/26 (0%) 0
    Upper respiratory tract infection 2/51 (3.9%) 2 1/50 (2%) 1 2/51 (3.9%) 2 1/49 (2%) 1 0/51 (0%) 0 1/25 (4%) 1 1/26 (3.8%) 1
    Injury, poisoning and procedural complications
    Animal bite 0/51 (0%) 0 0/50 (0%) 0 0/51 (0%) 0 1/49 (2%) 1 1/51 (2%) 1 0/25 (0%) 0 0/26 (0%) 0
    Ankle fracture 0/51 (0%) 0 0/50 (0%) 0 0/51 (0%) 0 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 1/26 (3.8%) 1
    Arthropod bite 0/51 (0%) 0 1/50 (2%) 1 0/51 (0%) 0 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Clavicle fracture 0/51 (0%) 0 0/50 (0%) 0 0/51 (0%) 0 0/49 (0%) 0 1/51 (2%) 1 0/25 (0%) 0 0/26 (0%) 0
    Contusion 1/51 (2%) 1 0/50 (0%) 0 1/51 (2%) 1 0/49 (0%) 0 1/51 (2%) 1 0/25 (0%) 0 0/26 (0%) 0
    Muscle strain 0/51 (0%) 0 0/50 (0%) 0 1/51 (2%) 1 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Tooth fracture 1/51 (2%) 1 0/50 (0%) 0 0/51 (0%) 0 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Investigations
    Alanine aminotransferase increased 0/51 (0%) 0 0/50 (0%) 0 0/51 (0%) 0 1/49 (2%) 1 0/51 (0%) 0 1/25 (4%) 1 0/26 (0%) 0
    Aspartate aminotransferase increased 0/51 (0%) 0 0/50 (0%) 0 0/51 (0%) 0 1/49 (2%) 1 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Blood creatinine increased 0/51 (0%) 0 1/50 (2%) 1 0/51 (0%) 0 1/49 (2%) 1 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Blood potassium increased 0/51 (0%) 0 0/50 (0%) 0 1/51 (2%) 1 2/49 (4.1%) 2 0/51 (0%) 0 0/25 (0%) 0 1/26 (3.8%) 2
    Blood pressure abnormal 1/51 (2%) 1 0/50 (0%) 0 0/51 (0%) 0 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Blood pressure increased 1/51 (2%) 1 0/50 (0%) 0 0/51 (0%) 0 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Blood pressure systolic increased 0/51 (0%) 0 0/50 (0%) 0 0/51 (0%) 0 0/49 (0%) 0 1/51 (2%) 1 0/25 (0%) 0 0/26 (0%) 0
    Electrocardiogram t wave inversion 0/51 (0%) 0 0/50 (0%) 0 1/51 (2%) 1 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Heart rate increased 0/51 (0%) 0 0/50 (0%) 0 0/51 (0%) 0 0/49 (0%) 0 1/51 (2%) 1 0/25 (0%) 0 0/26 (0%) 0
    Metabolism and nutrition disorders
    Fluid retention 0/51 (0%) 0 0/50 (0%) 0 0/51 (0%) 0 1/49 (2%) 1 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Gout 1/51 (2%) 1 0/50 (0%) 0 0/51 (0%) 0 0/49 (0%) 0 1/51 (2%) 1 0/25 (0%) 0 0/26 (0%) 0
    Hypercalcaemia 0/51 (0%) 0 0/50 (0%) 0 0/51 (0%) 0 0/49 (0%) 0 0/51 (0%) 0 1/25 (4%) 1 0/26 (0%) 0
    Hyperglycaemia 0/51 (0%) 0 0/50 (0%) 0 0/51 (0%) 0 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 1/26 (3.8%) 1
    Hyperkalaemia 2/51 (3.9%) 3 2/50 (4%) 3 1/51 (2%) 1 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Hypernatraemia 1/51 (2%) 1 0/50 (0%) 0 0/51 (0%) 0 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Musculoskeletal and connective tissue disorders
    Arthralgia 1/51 (2%) 1 0/50 (0%) 0 0/51 (0%) 0 0/49 (0%) 0 3/51 (5.9%) 3 0/25 (0%) 0 0/26 (0%) 0
    Back pain 2/51 (3.9%) 2 1/50 (2%) 1 1/51 (2%) 1 0/49 (0%) 0 2/51 (3.9%) 2 1/25 (4%) 1 1/26 (3.8%) 1
    Intervertebral disc protrusion 0/51 (0%) 0 0/50 (0%) 0 0/51 (0%) 0 0/49 (0%) 0 0/51 (0%) 0 1/25 (4%) 1 0/26 (0%) 0
    Muscle spasms 0/51 (0%) 0 1/50 (2%) 1 0/51 (0%) 0 2/49 (4.1%) 2 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Muscle tightness 0/51 (0%) 0 1/50 (2%) 1 0/51 (0%) 0 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Musculoskeletal pain 0/51 (0%) 0 1/50 (2%) 1 0/51 (0%) 0 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Musculoskeletal stiffness 0/51 (0%) 0 0/50 (0%) 0 0/51 (0%) 0 0/49 (0%) 0 1/51 (2%) 1 0/25 (0%) 0 0/26 (0%) 0
    Myalgia 0/51 (0%) 0 0/50 (0%) 0 0/51 (0%) 0 0/49 (0%) 0 0/51 (0%) 0 1/25 (4%) 1 0/26 (0%) 0
    Neck pain 0/51 (0%) 0 0/50 (0%) 0 1/51 (2%) 1 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Pain in extremity 0/51 (0%) 0 0/50 (0%) 0 1/51 (2%) 1 2/49 (4.1%) 2 2/51 (3.9%) 2 0/25 (0%) 0 0/26 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma 0/51 (0%) 0 0/50 (0%) 0 0/51 (0%) 0 0/49 (0%) 0 1/51 (2%) 1 0/25 (0%) 0 0/26 (0%) 0
    Nervous system disorders
    Balance disorder 0/51 (0%) 0 0/50 (0%) 0 0/51 (0%) 0 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 1/26 (3.8%) 1
    Dizziness 1/51 (2%) 1 1/50 (2%) 1 2/51 (3.9%) 2 1/49 (2%) 1 4/51 (7.8%) 4 1/25 (4%) 1 0/26 (0%) 0
    Headache 3/51 (5.9%) 4 5/50 (10%) 5 2/51 (3.9%) 2 1/49 (2%) 1 10/51 (19.6%) 10 3/25 (12%) 3 0/26 (0%) 0
    Hypoaesthesia 0/51 (0%) 0 0/50 (0%) 0 1/51 (2%) 1 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Migraine 0/51 (0%) 0 0/50 (0%) 0 0/51 (0%) 0 1/49 (2%) 1 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Paraesthesia 0/51 (0%) 0 0/50 (0%) 0 0/51 (0%) 0 0/49 (0%) 0 1/51 (2%) 1 1/25 (4%) 1 0/26 (0%) 0
    Presyncope 0/51 (0%) 0 0/50 (0%) 0 1/51 (2%) 1 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Tension headache 0/51 (0%) 0 0/50 (0%) 0 1/51 (2%) 1 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Psychiatric disorders
    Insomnia 0/51 (0%) 0 0/50 (0%) 0 0/51 (0%) 0 0/49 (0%) 0 3/51 (5.9%) 3 0/25 (0%) 0 0/26 (0%) 0
    Renal and urinary disorders
    Pollakiuria 0/51 (0%) 0 1/50 (2%) 1 0/51 (0%) 0 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Reproductive system and breast disorders
    Erectile dysfunction 0/35 (0%) 0 0/33 (0%) 0 0/27 (0%) 0 0/29 (0%) 0 1/30 (3.3%) 1 0/17 (0%) 0 0/19 (0%) 0
    Gynaecomastia 0/35 (0%) 0 0/33 (0%) 0 0/27 (0%) 0 0/29 (0%) 0 0/30 (0%) 0 0/17 (0%) 0 1/19 (5.3%) 1
    Spontaneous penile erection 0/35 (0%) 0 0/33 (0%) 0 0/27 (0%) 0 0/29 (0%) 0 1/30 (3.3%) 1 0/17 (0%) 0 0/19 (0%) 0
    Vulvovaginal dryness 0/16 (0%) 0 1/17 (5.9%) 1 0/24 (0%) 0 0/20 (0%) 0 0/21 (0%) 0 0/8 (0%) 0 0/7 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Cough 0/51 (0%) 0 0/50 (0%) 0 0/51 (0%) 0 0/49 (0%) 0 1/51 (2%) 1 0/25 (0%) 0 1/26 (3.8%) 1
    Dyspnoea 1/51 (2%) 1 0/50 (0%) 0 1/51 (2%) 1 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Epistaxis 0/51 (0%) 0 0/50 (0%) 0 0/51 (0%) 0 0/49 (0%) 0 1/51 (2%) 1 0/25 (0%) 0 0/26 (0%) 0
    Nasal congestion 1/51 (2%) 1 2/50 (4%) 3 0/51 (0%) 0 1/49 (2%) 1 1/51 (2%) 1 0/25 (0%) 0 0/26 (0%) 0
    Oropharyngeal pain 1/51 (2%) 1 1/50 (2%) 1 0/51 (0%) 0 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Paranasal cyst 0/51 (0%) 0 0/50 (0%) 0 0/51 (0%) 0 1/49 (2%) 1 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Productive cough 1/51 (2%) 1 0/50 (0%) 0 0/51 (0%) 0 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Respiratory tract congestion 0/51 (0%) 0 0/50 (0%) 0 0/51 (0%) 0 0/49 (0%) 0 1/51 (2%) 1 0/25 (0%) 0 1/26 (3.8%) 1
    Sinus congestion 0/51 (0%) 0 0/50 (0%) 0 0/51 (0%) 0 1/49 (2%) 1 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Wheezing 0/51 (0%) 0 0/50 (0%) 0 0/51 (0%) 0 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 1/26 (3.8%) 1
    Skin and subcutaneous tissue disorders
    Blister 1/51 (2%) 1 0/50 (0%) 0 0/51 (0%) 0 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Dermatitis 0/51 (0%) 0 1/50 (2%) 2 0/51 (0%) 0 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Dry skin 0/51 (0%) 0 1/50 (2%) 1 0/51 (0%) 0 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Erythema 1/51 (2%) 1 0/50 (0%) 0 0/51 (0%) 0 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Hyperhidrosis 0/51 (0%) 0 1/50 (2%) 1 0/51 (0%) 0 1/49 (2%) 1 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Night sweats 0/51 (0%) 0 1/50 (2%) 1 0/51 (0%) 0 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Pruritus 0/51 (0%) 0 1/50 (2%) 1 0/51 (0%) 0 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Rash 0/51 (0%) 0 0/50 (0%) 0 1/51 (2%) 1 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Transient acantholytic dermatosis 0/51 (0%) 0 0/50 (0%) 0 0/51 (0%) 0 0/49 (0%) 0 1/51 (2%) 1 0/25 (0%) 0 0/26 (0%) 0
    Urticaria 0/51 (0%) 0 0/50 (0%) 0 0/51 (0%) 0 1/49 (2%) 1 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Vascular disorders
    Flushing 0/51 (0%) 0 0/50 (0%) 0 0/51 (0%) 0 1/49 (2%) 1 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Hot flush 1/51 (2%) 1 0/50 (0%) 0 0/51 (0%) 0 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Hypertension 2/51 (3.9%) 2 0/50 (0%) 0 1/51 (2%) 1 1/49 (2%) 1 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0
    Orthostatic hypotension 0/51 (0%) 0 1/50 (2%) 1 0/51 (0%) 0 0/49 (0%) 0 0/51 (0%) 0 0/25 (0%) 0 0/26 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Chief Medical Officer
    Organization Eli Lilly and Company
    Phone 800-545-5979
    Email
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT02194465
    Other Study ID Numbers:
    • 15525
    • I7T-MC-RMAH
    First Posted:
    Jul 18, 2014
    Last Update Posted:
    Jun 26, 2020
    Last Verified:
    Jun 1, 2020