A Study of LY2623091 in Participants With High Blood Pressure
- Conditions
- Primary Hypertension
- Interventions
- Registration Number
- NCT02194465
- Lead Sponsor
- Eli Lilly and Company
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 304
-
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 6 milligrams (mg) LY2623091 Placebo 6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks. 6 milligrams (mg) LY2623091 LY2623091 6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks. 13 mg LY2623091 LY2623091 13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks. 13 mg LY2623091 Placebo 13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks. 24.5 mg LY2623091 LY2623091 24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks. 24.5 mg LY2623091 Placebo 24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks. 13 mg LY2623091 + 20 mg tadalafil Placebo 13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks. 20 mg tadalafil Placebo 20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks. Placebo Placebo Placebo for blinding administered orally once daily for 4 weeks. 13 mg LY2623091 + 20 mg tadalafil LY2623091 13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks. 13 mg LY2623091 + 20 mg tadalafil Tadalafil 13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks. 20 mg tadalafil Tadalafil 20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks. Spironolactone Spironolactone 25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
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).
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.
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2623091 2 hours post-dose at 4 Weeks
Trial Locations
- Locations (36)
Cor Clinical Research LLC
🇺🇸Oklahoma City, Oklahoma, United States
Clinical Research Puerto Rico, Inc.
🇵🇷San Juan, Puerto Rico
Mountain View Clinical Research, Inc
🇺🇸Greer, South Carolina, United States
John Muir Health Network - The Osteoporosis Center
🇺🇸Concord, California, United States
Clinical Research Advantage
🇺🇸Glendale, Arizona, United States
Encompass Clinical Research
🇺🇸Encinitas, California, United States
Avail Clinical Research LLC
🇺🇸DeLand, Florida, United States
Rocky Mountain Diabetes and Osteoporosis Center
🇺🇸Idaho Falls, Idaho, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Midwest Institute for Clinical Research
🇺🇸Indianapolis, Indiana, United States
Cedar-Crosse Research Center
🇺🇸Chicago, Illinois, United States
Community Clinical Research Center
🇺🇸Muncie, Indiana, United States
Grace Research
🇺🇸Bossier City, Louisiana, United States
Maine Research Associates
🇺🇸Auburn, Maine, United States
AB Clinical Trials
🇺🇸Las Vegas, Nevada, United States
Metrolina Internal Medicine, P.A.
🇺🇸Charlotte, North Carolina, United States
PharmQuest
🇺🇸Greensboro, North Carolina, United States
Sterling Research Group, LTD
🇺🇸Cincinnati, Ohio, United States
Lillestol Research LLC
🇺🇸Fargo, North Dakota, United States
Rapid Medical Research Inc
🇺🇸Cleveland, Ohio, United States
Dayton Clinical Research
🇺🇸Dayton, Ohio, United States
Columbus Clinical Research
🇺🇸Columbus, Ohio, United States
Texas Diabetes and Endocrinology, P.A.
🇺🇸Round Rock, Texas, United States
Universal Research Group, LLC
🇺🇸Tacoma, Washington, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, 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.
🇨🇦Toronto, Canada
Research and Cardiovascular Corp.
🇵🇷Ponce, Puerto Rico
Cardiovascular Center of Sarasota
🇺🇸Sarasota, Florida, United States
Alan Graff, MD, PA
🇺🇸Fort Lauderdale, Florida, United States
Northwest Heart Clinical Research, LLC
🇺🇸Arlington Heights, Illinois, United States
Rochester Clinical Research, Inc.
🇺🇸Rochester, New York, United States
Oklahoma Foundation For Cardiovascular Research
🇺🇸Oklahoma City, Oklahoma, United States
East West Medical Institute
🇺🇸Honolulu, Hawaii, United States
Texas Diabetes and Endocrinology
🇺🇸Austin, Texas, United States
Tekton Research, Inc
🇺🇸Austin, Texas, United States
Heartland Research Associates
🇺🇸Wichita, Kansas, United States