A Study of LY2623091 in Participants With High Blood Pres... | NCT02194465 | Trialant
NCT02194465
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Jun 26, 2020Actual
Enrollment
304Actual
Phase
Phase 2
Conditions
Primary Hypertension
Interventions
LY2623091
Tadalafil
Spironolactone
Placebo
Countries
United States
Canada
Puerto Rico
Protocol Section
Identification Module
NCT ID
NCT02194465
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
15525
Secondary IDs
ID
Type
Description
Link
I7T-MC-RMAH
Other Identifier
Eli Lilly and Company
Brief Title
A Study of LY2623091 in Participants With High Blood Pressure
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
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Jun 2020
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 2014
Primary Completion Date
Mar 2015Actual
Completion Date
Mar 2015Actual
First Submitted Date
Jul 17, 2014
First Submission Date that Met QC Criteria
Jul 17, 2014
First Posted Date
Jul 18, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 9, 2020
Results First Submitted that Met QC Criteria
Jun 9, 2020
Results First Posted Date
Jun 26, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
May 8, 2015
Certification/Extension First Submitted that Passed QC Review
May 8, 2015
Certification/Extension First Posted Date
May 25, 2015Estimated
Last Update Submitted Date
Jun 9, 2020
Last Update Posted Date
Jun 26, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Detailed Description
Not provided
Conditions Module
Conditions
Primary Hypertension
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
304Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
6 milligrams (mg) LY2623091
Experimental
6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
Drug: LY2623091
Drug: Placebo
13 mg LY2623091
Experimental
13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
Drug: LY2623091
Drug: Placebo
24.5 mg LY2623091
Experimental
24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
Drug: LY2623091
Drug: Placebo
13 mg LY2623091 + 20 mg tadalafil
Experimental
13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks.
Drug: LY2623091
Drug: Tadalafil
Drug: Placebo
20 mg tadalafil
Experimental
20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks.
Drug: Tadalafil
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LY2623091
Drug
Administered orally
13 mg LY2623091
13 mg LY2623091 + 20 mg tadalafil
24.5 mg LY2623091
6 milligrams (mg) LY2623091
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline to 4 Weeks in Seated Systolic Blood Pressure (SBP)
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.
Baseline, 4 Weeks
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline to 4 Weeks in Seated Diastolic Blood Pressure (DBP)
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.
Baseline, 4 Weeks
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
80 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
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 Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Clinical Research Advantage
Glendale
Arizona
85306
United States
John Muir Health Network - The Osteoporosis Center
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Participants entered at lead-in for wash out and a placebo run-in period prior to randomization.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Placebo for blinding administered orally once daily for 4 weeks.
FG001
6 Milligrams (mg) LY2623091
6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
1
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Spironolactone
Active Comparator
25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.
Drug: Spironolactone
Placebo
Placebo Comparator
Placebo for blinding administered orally once daily for 4 weeks.
Drug: Placebo
Mineralocorticoid Receptor Antagonist
Tadalafil
Drug
Administered orally
13 mg LY2623091 + 20 mg tadalafil
20 mg tadalafil
LY450190
Spironolactone
Drug
Administered orally
Spironolactone
Placebo
Drug
Administered orally
13 mg LY2623091
13 mg LY2623091 + 20 mg tadalafil
20 mg tadalafil
24.5 mg LY2623091
6 milligrams (mg) LY2623091
Placebo
Change From Baseline to 4 Weeks in 24 Hour Ambulatory Blood Pressure Monitoring (ABPM)
The LS mean change in blood pressure is calculated after adjusting for baseline, treatment and race using an analysis of covariance (ANCOVA).
Baseline, 4 Weeks
Change From Baseline to 4 Weeks in Serum Potassium
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.
Baseline, 4 Weeks
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2623091
2 hours post-dose at 4 Weeks
Concord
California
94520
United States
Encompass Clinical Research
Encinitas
California
92024
United States
Avail Clinical Research LLC
DeLand
Florida
32720
United States
Alan Graff, MD, PA
Fort Lauderdale
Florida
33308
United States
Jacksonville Center for Clinical Research
Jacksonville
Florida
32216
United States
Cardiovascular Center of Sarasota
Sarasota
Florida
34239
United States
East West Medical Institute
Honolulu
Hawaii
96814
United States
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls
Idaho
83404
United States
Northwest Heart Clinical Research, LLC
Arlington Heights
Illinois
60005
United States
Cedar-Crosse Research Center
Chicago
Illinois
60607
United States
Midwest Institute for Clinical Research
Indianapolis
Indiana
46260
United States
Community Clinical Research Center
Muncie
Indiana
47304
United States
Heartland Research Associates
Wichita
Kansas
67207
United States
Grace Research
Bossier City
Louisiana
71111
United States
Maine Research Associates
Auburn
Maine
04210
United States
AB Clinical Trials
Las Vegas
Nevada
89119
United States
Rochester Clinical Research, Inc.
Rochester
New York
14609
United States
Metrolina Internal Medicine, P.A.
Charlotte
North Carolina
28204
United States
PharmQuest
Greensboro
North Carolina
27408
United States
Lillestol Research LLC
Fargo
North Dakota
58103
United States
Sterling Research Group, LTD
Cincinnati
Ohio
45219
United States
Rapid Medical Research Inc
Cleveland
Ohio
44122
United States
Columbus Clinical Research
Columbus
Ohio
43213
United States
Dayton Clinical Research
Dayton
Ohio
45406
United States
Cor Clinical Research LLC
Oklahoma City
Oklahoma
4052728481
United States
Oklahoma Foundation For Cardiovascular Research
Oklahoma City
Oklahoma
73120
United States
Mountain View Clinical Research, Inc
Greer
South Carolina
29651
United States
Texas Diabetes and Endocrinology
Austin
Texas
78731-4309
United States
Tekton Research, Inc
Austin
Texas
78745
United States
Texas Diabetes and Endocrinology, P.A.
Round Rock
Texas
78681
United States
Northwest Clinical Research Center
Bellevue
Washington
98007-4209
United States
Universal Research Group, LLC
Tacoma
Washington
98405
United States
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
L6T 0G1
Canada
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
V1Y3G8
Canada
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
K9J 0B2
Canada
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
H9R 4S3
Canada
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.
Québec
G1N 4V3
Canada
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
T4N 6V7
Canada
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
J1J 2G2
Canada
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
M9W 4L6
Canada
Research and Cardiovascular Corp.
Ponce
00717-1322
Puerto Rico
Clinical Research Puerto Rico, Inc.
San Juan
00909
Puerto Rico
FG002
13 mg LY2623091
13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
FG003
24.5 mg LY2623091
24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
FG004
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.
FG005
20 mg Tadalafil
20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks.
FG006
Spironolactone
25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.
FG00051 subjects
FG00150 subjects
FG00252 subjects
FG00349 subjects
FG00451 subjects
FG00525 subjects
FG00626 subjects
Received at Least 1 Dose of Study Drug
FG00051 subjects
FG00150 subjects
FG00251 subjects
FG00349 subjects
FG00451 subjects
FG00525 subjects
FG00626 subjects
COMPLETED
FG00042 subjects
FG00143 subjects
FG00244 subjects
FG00341 subjects
FG00442 subjects
FG00521 subjects
FG00624 subjects
NOT COMPLETED
FG0009 subjects
FG0017 subjects
FG0028 subjects
FG0038 subjects
FG0049 subjects
FG0054 subjects
FG0062 subjects
Type
Comment
Reasons
Adverse Event
FG0006 subjects
FG0011 subjects
FG0024 subjects
FG0034 subjects
FG0044 subjects
FG0052 subjects
FG0060 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Physician Decision
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0001 subjects
FG0011 subjects
FG0022 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0013 subjects
FG0021 subjects
FG0032 subjects
FG004
Discontinued follow-up period
FG0000 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
FG004
All randomized participants who received at least 1 dose of a study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Placebo for blinding administered orally once daily for 4 weeks.
BG001
6 mg LY2623091
6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
BG002
13 mg LY2623091
13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
BG003
24.5 mg LY2623091
24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
BG004
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.
BG005
20 mg Tadalafil
20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks.
BG006
Spironolactone
25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00051
BG00150
BG00251
BG00349
BG00451
BG00525
BG00626
BG007303
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
ParticipantsBG00051
ParticipantsBG00150
ParticipantsBG00251
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
ParticipantsBG00051
ParticipantsBG00150
ParticipantsBG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
ParticipantsBG00051
ParticipantsBG00150
ParticipantsBG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
ParticipantsBG00051
ParticipantsBG00150
ParticipantsBG002
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
Canada
ParticipantsBG00051
ParticipantsBG00150
ParticipantsBG002
BMI
Mean
Standard Deviation
kilogram/square meter (kg/m2)
Title
Denominators
Categories
ParticipantsBG00051
ParticipantsBG00150
ParticipantsBG002
Chronic Kidney Disease (CKD)
Count of Participants
Participants
No
Title
Denominators
Categories
Y
ParticipantsBG00051
ParticipantsBG00150
ParticipantsBG002
Anti-Hypertensive Medication
Count of Participants
Participants
No
Title
Denominators
Categories
0
ParticipantsBG00051
ParticipantsBG00150
ParticipantsBG002
Diabetes
Count of Participants
Participants
No
Title
Denominators
Categories
Y
ParticipantsBG00051
ParticipantsBG00150
ParticipantsBG002
Baseline in Seated Systolic Blood Pressure (SBP)
Mean
Standard Deviation
millimeter of mercury (mmHg)
Title
Denominators
Categories
ParticipantsBG00051
ParticipantsBG00150
ParticipantsBG002
Baseline in Seated Diastolic Blood Pressure (DBP)
All randomized participants receiving at least 1 dose of a study drug and had baseline seated Diastolic Blood Pressure data.
Mean
Standard Deviation
millimeter of mercury (mmHg)
Title
Denominators
Categories
ParticipantsBG00051
ParticipantsBG00149
ParticipantsBG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change From Baseline to 4 Weeks in Seated Systolic Blood Pressure (SBP)
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.
All randomized participants receiving at least 1 dose of the study drug and had baseline and post baseline evaluable data for SBP.
Posted
Least Squares Mean
Standard Error
millimeter of mercury (mmHg)
Baseline, 4 Weeks
ID
Title
Description
OG000
Placebo
Placebo for blinding administered orally once daily for 4 weeks.
OG001
6 mg LY2623091
6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
OG002
13 mg LY2623091
13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
OG003
24.5 mg LY2623091
24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
OG004
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.
OG005
20 mg Tadalafil
20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks.
OG006
Spironolactone
25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.
Units
Counts
Participants
OG00041
OG00145
OG00243
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.5± 11.6
OG001-13.1± 11.2
OG002-14.6± 12.3
OG003
Secondary
Change From Baseline to 4 Weeks in Seated Diastolic Blood Pressure (DBP)
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.
All randomized participants receiving at least 1 dose of the study drug and had baseline and post baseline evaluable data for DBP.
Posted
Least Squares Mean
Standard Error
mmHg
Baseline, 4 Weeks
ID
Title
Description
OG000
Placebo
Placebo for blinding administered orally once daily for 4 weeks.
OG001
6 mg LY2623091
6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
OG002
13 mg LY2623091
13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
OG003
24.5 mg LY2623091
24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
Secondary
Change From Baseline to 4 Weeks in 24 Hour Ambulatory Blood Pressure Monitoring (ABPM)
The LS mean change in blood pressure is calculated after adjusting for baseline, treatment and race using an analysis of covariance (ANCOVA).
All randomized participants receiving at least 1 dose of the study drug and had evaluable data for 24 hour ABPM.
Posted
Least Squares Mean
Standard Error
mmHg
Baseline, 4 Weeks
ID
Title
Description
OG000
Placebo
Placebo for blinding administered orally once daily for 4 weeks.
OG001
6 mg LY2623091
6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
OG002
13 mg LY2623091
13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
OG003
24.5 mg LY2623091
24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
Secondary
Change From Baseline to 4 Weeks in Serum Potassium
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.
All randomized participants receiving at least 1 dose of the study drug and had evaluable data for serum potassium.
Posted
Least Squares Mean
Standard Error
millimoles/L (mmol/L)
Baseline, 4 Weeks
ID
Title
Description
OG000
Placebo
Placebo for blinding administered orally once daily for 4 weeks.
OG001
6 mg LY2623091
6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
OG002
13 mg LY2623091
13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
OG003
24.5 mg LY2623091
24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
Secondary
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2623091
All participants who had evaluable PK data of LY2623091.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanogram/milliliter (ng/ml)
2 hours post-dose at 4 Weeks
ID
Title
Description
OG000
6 mg LY2623091
6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
OG001
13 mg LY2623091
13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
OG002
24.5 mg LY2623091
24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
OG003
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.
Time Frame
Not provided
Description
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo
Placebo for blinding administered orally once daily for 4 weeks.
0
51
23
51
EG001
6 mg LY2623091
6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
0
50
23
50
EG002
13 mg LY2623091
13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
2
51
21
51
EG003
24.5 mg LY2623091
24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
0
49
18
49
EG004
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.
1
51
34
51
EG005
20 mg Tadalafil
20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks.
0
25
14
25
EG006
Spironolactone
25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.
0
26
12
26
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Inguinal hernia
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG0030 events0 affected49 at risk
EG0041 events1 affected51 at risk
EG0050 events0 affected25 at risk
EG0060 events0 affected26 at risk
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0021 events1 affected51 at risk
EG003
Diabetic foot
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0021 events1 affected51 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Leukocytosis
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG0031 events1 affected49 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected25 at risk
EG0060 events0 affected26 at risk
Neutrophilia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Bundle branch block right
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0021 events1 affected51 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0021 events1 affected51 at risk
EG003
Eyelid oedema
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Scleral haemorrhage
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Visual impairment
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0021 events1 affected51 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected51 at risk
EG0011 events1 affected50 at risk
EG0021 events1 affected51 at risk
EG003
Diverticulum
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0021 events1 affected51 at risk
EG003
Diverticulum intestinal
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0021 events1 affected51 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0021 events1 affected51 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Faecal incontinence
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Faeces soft
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Lip swelling
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Chest discomfort
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Fatigue
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Feeling abnormal
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0021 events1 affected51 at risk
EG003
Oedema peripheral
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Pain
General disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Peripheral swelling
General disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected51 at risk
EG0010 events0 affected50 at risk
EG0021 events1 affected51 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Non-alcoholic steatohepatitis
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0021 events1 affected51 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Bronchitis viral
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Epididymitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected27 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Joint abscess
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected51 at risk
EG0014 events4 affected50 at risk
EG0022 events2 affected51 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0002 events2 affected51 at risk
EG0011 events1 affected50 at risk
EG0022 events2 affected51 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected51 at risk
EG0010 events0 affected50 at risk
EG0021 events1 affected51 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0021 events1 affected51 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Blood potassium increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0021 events1 affected51 at risk
EG003
Blood pressure abnormal
Investigations
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Blood pressure increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Blood pressure systolic increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Electrocardiogram t wave inversion
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0021 events1 affected51 at risk
EG003
Heart rate increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Fluid retention
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0003 events2 affected51 at risk
EG0013 events2 affected50 at risk
EG0021 events1 affected51 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0002 events2 affected51 at risk
EG0011 events1 affected50 at risk
EG0021 events1 affected51 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Muscle tightness
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0021 events1 affected51 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0021 events1 affected51 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected51 at risk
EG0011 events1 affected50 at risk
EG0022 events2 affected51 at risk
EG003
Headache
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0004 events3 affected51 at risk
EG0015 events5 affected50 at risk
EG0022 events2 affected51 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0021 events1 affected51 at risk
EG003
Migraine
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0021 events1 affected51 at risk
EG003
Tension headache
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0021 events1 affected51 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected27 at risk
EG003
Gynaecomastia
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected27 at risk
EG003
Spontaneous penile erection
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected35 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected27 at risk
EG003
Vulvovaginal dryness
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected24 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected51 at risk
EG0010 events0 affected50 at risk
EG0021 events1 affected51 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected51 at risk
EG0013 events2 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected51 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Paranasal cyst
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0012 events1 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0021 events1 affected51 at risk
EG003
Transient acantholytic dermatosis
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Flushing
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Hot flush
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected51 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Hypertension
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0002 events2 affected51 at risk
EG0010 events0 affected50 at risk
EG0021 events1 affected51 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected51 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected51 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
GT60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Chief Medical Officer
Eli Lilly and Company
800-545-5979
ID
Term
D000075222
Essential Hypertension
Ancestor Terms
ID
Term
D006973
Hypertension
D014652
Vascular Diseases
D002318
Cardiovascular Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000451
Mineralocorticoid Receptor Antagonists
D000068581
Tadalafil
D013148
Spironolactone
Ancestor Terms
ID
Term
D006727
Hormone Antagonists
D006730
Hormones, Hormone Substitutes, and Hormone Antagonists
D045505
Physiological Effects of Drugs
D020228
Pharmacologic Actions
D020164
Chemical Actions and Uses
D062865
Diuretics, Potassium Sparing
D004232
Diuretics
D045283
Natriuretic Agents
D002243
Carbolines
D011725
Pyridines
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
D026121
Indole Alkaloids
D007211
Indoles
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D006575
Heterocyclic Compounds, 3-Ring
D007783
Lactones
D009930
Organic Chemicals
D011283
Pregnenes
D011278
Pregnanes
D013256
Steroids
D000072473
Fused-Ring Compounds
D011083
Polycyclic Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0051 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
1 subjects
FG0050 subjects
FG0060 subjects
2 subjects
FG0051 subjects
FG0062 subjects
2 subjects
FG0050 subjects
FG0060 subjects
49
ParticipantsBG00451
ParticipantsBG00525
ParticipantsBG00626
ParticipantsBG007303
Title
Measurements
BG00058.6± 9.4
BG00156.6± 11.4
BG00258.0± 8.8
BG00358.7± 8.8
BG00457.9± 9.5
BG00554.0± 8.9
BG00659.0± 11.0
BG00757.7± 9.7
51
ParticipantsBG00349
ParticipantsBG00451
ParticipantsBG00525
ParticipantsBG00626
ParticipantsBG007303
Title
Measurements
Female
BG00016
BG00117
BG00224
BG00320
BG00421
BG0058
BG0067
BG007113
Male
BG00035
BG00133
BG00227
BG00329
BG004
51
ParticipantsBG00349
ParticipantsBG00451
ParticipantsBG00525
ParticipantsBG00626
ParticipantsBG007303
Title
Measurements
Hispanic or Latino
BG0002
BG0015
BG0022
BG0032
BG0044
BG0054
BG0061
BG00720
Not Hispanic or Latino
BG00042
BG00139
BG00245
BG00339
BG004
Unknown or Not Reported
BG0007
BG0016
BG0024
BG0038
BG004
51
ParticipantsBG00349
ParticipantsBG00451
ParticipantsBG00525
ParticipantsBG00626
ParticipantsBG007303
Title
Measurements
American Indian or Alaska Native
BG0001
BG0010
BG0021
BG0032
BG0041
BG0050
BG0060
BG0075
Asian
BG0007
BG0014
BG0022
BG0036
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG00013
BG00115
BG00214
BG00312
BG004
White
BG00028
BG00130
BG00234
BG00329
BG004
More than one race
BG0002
BG0011
BG0020
BG0030
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
51
ParticipantsBG00349
ParticipantsBG00451
ParticipantsBG00525
ParticipantsBG00626
ParticipantsBG007303
Title
Measurements
BG00018
BG00112
BG0029
BG00313
BG00413
BG0055
BG0064
BG00774
United States
ParticipantsBG00051
ParticipantsBG00150
ParticipantsBG00251
ParticipantsBG00349
ParticipantsBG00451
ParticipantsBG00525
ParticipantsBG00626
ParticipantsBG007303
Title
Measurements
BG00032
BG00136
BG00241
BG003
Puerto Rico
ParticipantsBG00051
ParticipantsBG00150
ParticipantsBG00251
ParticipantsBG00349
ParticipantsBG00451
ParticipantsBG00525
ParticipantsBG00626
ParticipantsBG007303
Title
Measurements
BG0001
BG0012
BG0021
BG003
51
ParticipantsBG00349
ParticipantsBG00451
ParticipantsBG00525
ParticipantsBG00626
ParticipantsBG007303
Title
Measurements
BG00030.5± 4.5
BG00130.2± 5.2
BG00230.2± 4.9
BG00332.7± 4.5
BG00429.5± 4.7
BG00529.6± 4.2
BG00631.4± 4.5
BG00730.6± 4.8
51
ParticipantsBG00349
ParticipantsBG00451
ParticipantsBG00525
ParticipantsBG00626
ParticipantsBG007303
Title
Measurements
BG0000
BG0013
BG0022
BG0030
BG0040
BG0052
BG0062
BG0079
N
ParticipantsBG00051
ParticipantsBG00150
ParticipantsBG00251
ParticipantsBG00349
ParticipantsBG00451
ParticipantsBG00525
ParticipantsBG00626
ParticipantsBG007303
Title
Measurements
BG00051
BG00147
BG00249
BG003
51
ParticipantsBG00349
ParticipantsBG00451
ParticipantsBG00525
ParticipantsBG00626
ParticipantsBG007303
Title
Measurements
BG0008
BG00110
BG0025
BG0037
BG00413
BG0056
BG0063
BG00752
1
ParticipantsBG00051
ParticipantsBG00150
ParticipantsBG00251
ParticipantsBG00349
ParticipantsBG00451
ParticipantsBG00525
ParticipantsBG00626
ParticipantsBG007303
Title
Measurements
BG00024
BG00122
BG00225
BG003
2
ParticipantsBG00051
ParticipantsBG00150
ParticipantsBG00251
ParticipantsBG00349
ParticipantsBG00451
ParticipantsBG00525
ParticipantsBG00626
ParticipantsBG007303
Title
Measurements
BG00019
BG00117
BG00220
BG003
3
ParticipantsBG00051
ParticipantsBG00150
ParticipantsBG00251
ParticipantsBG00349
ParticipantsBG00451
ParticipantsBG00525
ParticipantsBG00626
ParticipantsBG007303
Title
Measurements
BG0000
BG0011
BG0021
BG003
4
ParticipantsBG00051
ParticipantsBG00150
ParticipantsBG00251
ParticipantsBG00349
ParticipantsBG00451
ParticipantsBG00525
ParticipantsBG00626
ParticipantsBG007303
Title
Measurements
BG0000
BG0010
BG0020
BG003
51
ParticipantsBG00349
ParticipantsBG00451
ParticipantsBG00525
ParticipantsBG00626
ParticipantsBG007303
Title
Measurements
BG00010
BG0016
BG00211
BG0039
BG0045
BG0056
BG0064
BG00751
N
ParticipantsBG00051
ParticipantsBG00150
ParticipantsBG00251
ParticipantsBG00349
ParticipantsBG00451
ParticipantsBG00525
ParticipantsBG00626
ParticipantsBG007303
Title
Measurements
BG00041
BG00144
BG00240
BG003
51
ParticipantsBG00349
ParticipantsBG00451
ParticipantsBG00525
ParticipantsBG00626
ParticipantsBG007303
Title
Measurements
BG000151.2± 8.8
BG001150.8± 8.6
BG002153.7± 8.3
BG003150.7± 10.2
BG004152.1± 9.6
BG005151.7± 9.6
BG006153.4± 9.0
BG007151.9± 9.1
51
ParticipantsBG00349
ParticipantsBG00451
ParticipantsBG00524
ParticipantsBG00625
ParticipantsBG007300
Title
Measurements
BG00089.8± 8.8
BG00188.2± 9.7
BG00290.5± 9.5
BG00388.5± 8.5
BG00490.6± 8.9
BG00591.5± 8.8
BG00688.6± 11.6
BG00789.6± 9.3
41
OG00443
OG00521
OG00623
-14.3
± 13.6
OG004-11.8± 12.5
OG005-7.1± 13.3
OG006-15.4± 11.7
OG004
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.
OG005
20 mg Tadalafil
20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks.
OG006
Spironolactone
25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.
Units
Counts
Participants
OG00041
OG00145
OG00243
OG00341
OG00443
OG00521
OG00623
Title
Denominators
Categories
Title
Measurements
OG0000.5± 7.9
OG001-5.6± 9.2
OG002-4.8± 7.2
OG003-7.1± 7.6
OG004-6.8± 8.7
OG005-6.6± 8.7
OG006-1.2± 6.1
OG004
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.
OG005
20 mg Tadalafil
20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks.
OG006
Spironolactone
25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.
Units
Counts
Participants
OG00037
OG00137
OG00239
OG00333
OG00436
OG00519
OG00622
Title
Denominators
Categories
SBP
Title
Measurements
OG0000.3± 11.3
OG001-4.9± 8.7
OG002-11.1± 8.9
OG003-10.4± 11.4
OG004-10.4± 11.6
OG005-6.3± 8.9
OG006-6.4± 6.8
DBP
Title
Measurements
OG0001.0± 7.7
OG001-1.7± 6.3
OG002-4.7± 6.1
OG003
OG004
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.
OG005
20 mg Tadalafil
20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks.
OG006
Spironolactone
25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.