Back to resultsA Study of LY2623091 in Participants With High Blood Pressure
Primary Purpose
Primary Hypertension
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
LY2623091
Tadalafil
Spironolactone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Primary Hypertension
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.
Sites / Locations
- Clinical Research Advantage
- John Muir Health Network - The Osteoporosis Center
- Encompass Clinical Research
- Avail Clinical Research LLC
- Alan Graff, MD, PA
- Jacksonville Center for Clinical Research
- Cardiovascular Center of Sarasota
- East West Medical Institute
- Rocky Mountain Diabetes and Osteoporosis Center
- Northwest Heart Clinical Research, LLC
- Cedar-Crosse Research Center
- Midwest Institute for Clinical Research
- Community Clinical Research Center
- Heartland Research Associates
- Grace Research
- Maine Research Associates
- AB Clinical Trials
- Rochester Clinical Research, Inc.
- Metrolina Internal Medicine, P.A.
- PharmQuest
- Lillestol Research LLC
- Sterling Research Group, LTD
- Rapid Medical Research Inc
- Columbus Clinical Research
- Dayton Clinical Research
- Cor Clinical Research LLC
- Oklahoma Foundation For Cardiovascular Research
- Mountain View Clinical Research, Inc
- Texas Diabetes and Endocrinology
- Tekton Research, Inc
- Texas Diabetes and Endocrinology, P.A.
- Northwest Clinical Research Center
- Universal Research Group, LLC
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Research and Cardiovascular Corp.
- Clinical Research Puerto Rico, Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
6 milligrams (mg) LY2623091
13 mg LY2623091
24.5 mg LY2623091
13 mg LY2623091 + 20 mg tadalafil
20 mg tadalafil
Spironolactone
Placebo
Arm 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.
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.
Placebo for blinding administered orally once daily for 4 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
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.
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2623091
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02194465
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
304 (Actual)
8. Arms, Groups, and Interventions
Arm Title
6 milligrams (mg) LY2623091
Arm Type
Experimental
Arm Description
6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
Arm Title
13 mg LY2623091
Arm Type
Experimental
Arm Description
13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
Arm Title
24.5 mg LY2623091
Arm Type
Experimental
Arm Description
24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
Arm Title
13 mg LY2623091 + 20 mg tadalafil
Arm Type
Experimental
Arm Description
13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks.
Arm Title
20 mg tadalafil
Arm Type
Experimental
Arm Description
20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks.
Arm Title
Spironolactone
Arm Type
Active Comparator
Arm Description
25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for blinding administered orally once daily for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
LY2623091
Other Intervention Name(s)
Mineralocorticoid Receptor Antagonist
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
Tadalafil
Other Intervention Name(s)
LY450190
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
Spironolactone
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered orally
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
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
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
Title
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2623091
Time Frame
2 hours post-dose at 4 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Research Advantage
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
John Muir Health Network - The Osteoporosis Center
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
Encompass Clinical Research
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Avail Clinical Research LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Alan Graff, MD, PA
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Cardiovascular Center of Sarasota
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
East West Medical Institute
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Rocky Mountain Diabetes and Osteoporosis Center
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Northwest Heart Clinical Research, LLC
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Cedar-Crosse Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Midwest Institute for Clinical Research
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Community Clinical Research Center
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47304
Country
United States
Facility Name
Heartland Research Associates
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Grace Research
City
Bossier City
State/Province
Louisiana
ZIP/Postal Code
71111
Country
United States
Facility Name
Maine Research Associates
City
Auburn
State/Province
Maine
ZIP/Postal Code
04210
Country
United States
Facility Name
AB Clinical Trials
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Rochester Clinical Research, Inc.
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Metrolina Internal Medicine, P.A.
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
PharmQuest
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Lillestol Research LLC
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Sterling Research Group, LTD
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Rapid Medical Research Inc
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Columbus Clinical Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Dayton Clinical Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45406
Country
United States
Facility Name
Cor Clinical Research LLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
4052728481
Country
United States
Facility Name
Oklahoma Foundation For Cardiovascular Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Mountain View Clinical Research, Inc
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Texas Diabetes and Endocrinology
City
Austin
State/Province
Texas
ZIP/Postal Code
78731-4309
Country
United States
Facility Name
Tekton Research, Inc
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Texas Diabetes and Endocrinology, P.A.
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007-4209
Country
United States
Facility Name
Universal Research Group, LLC
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
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.
City
Brampton
ZIP/Postal Code
L6T 0G1
Country
Canada
Facility Name
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.
City
Kelowna
ZIP/Postal Code
V1Y3G8
Country
Canada
Facility Name
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.
City
Peterborough
ZIP/Postal Code
K9J 0B2
Country
Canada
Facility Name
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.
City
Pointe Claire
ZIP/Postal Code
H9R 4S3
Country
Canada
Facility Name
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.
City
Quebec City
ZIP/Postal Code
G1N 4V3
Country
Canada
Facility Name
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.
City
Red Deer
ZIP/Postal Code
T4N 6V7
Country
Canada
Facility Name
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.
City
Sherbrooke
ZIP/Postal Code
J1J 2G2
Country
Canada
Facility Name
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.
City
Toronto
ZIP/Postal Code
M9W 4L6
Country
Canada
Facility Name
Research and Cardiovascular Corp.
City
Ponce
ZIP/Postal Code
00717-1322
Country
Puerto Rico
Facility Name
Clinical Research Puerto Rico, Inc.
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan 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.
IPD Sharing 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.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
https://vivli.org
Learn more about this trial
A Study of LY2623091 in Participants With High Blood Pressure
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