A Study of LY2623091 in Participants With High Blood Pressure
NCT ID: NCT02194465
Last Updated: 2020-06-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
304 participants
INTERVENTIONAL
2014-08-31
2015-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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6 milligrams (mg) LY2623091
6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
LY2623091
Administered orally
Placebo
Administered orally
13 mg LY2623091
13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
LY2623091
Administered orally
Placebo
Administered orally
24.5 mg LY2623091
24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
LY2623091
Administered orally
Placebo
Administered orally
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.
LY2623091
Administered orally
Tadalafil
Administered orally
Placebo
Administered orally
20 mg tadalafil
20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks.
Tadalafil
Administered orally
Placebo
Administered orally
Spironolactone
25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.
Spironolactone
Administered orally
Placebo
Placebo for blinding administered orally once daily for 4 weeks.
Placebo
Administered orally
Interventions
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LY2623091
Administered orally
Tadalafil
Administered orally
Spironolactone
Administered orally
Placebo
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
80 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Clinical Research Advantage
Glendale, Arizona, United States
John Muir Health Network - The Osteoporosis Center
Concord, California, United States
Encompass Clinical Research
Encinitas, California, United States
Avail Clinical Research LLC
DeLand, Florida, United States
Alan Graff, MD, PA
Fort Lauderdale, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Cardiovascular Center of Sarasota
Sarasota, Florida, United States
East West Medical Institute
Honolulu, Hawaii, United States
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, United States
Northwest Heart Clinical Research, LLC
Arlington Heights, Illinois, United States
Cedar-Crosse Research Center
Chicago, Illinois, United States
Midwest Institute for Clinical Research
Indianapolis, Indiana, United States
Community Clinical Research Center
Muncie, Indiana, United States
Heartland Research Associates
Wichita, Kansas, United States
Grace Research
Bossier City, Louisiana, United States
Maine Research Associates
Auburn, Maine, United States
AB Clinical Trials
Las Vegas, Nevada, United States
Rochester Clinical Research, Inc.
Rochester, New York, United States
Metrolina Internal Medicine, P.A.
Charlotte, North Carolina, United States
PharmQuest
Greensboro, North Carolina, United States
Lillestol Research LLC
Fargo, North Dakota, United States
Sterling Research Group, LTD
Cincinnati, Ohio, United States
Rapid Medical Research Inc
Cleveland, Ohio, United States
Columbus Clinical Research
Columbus, Ohio, United States
Dayton Clinical Research
Dayton, Ohio, United States
Cor Clinical Research LLC
Oklahoma City, Oklahoma, United States
Oklahoma Foundation For Cardiovascular Research
Oklahoma City, Oklahoma, United States
Mountain View Clinical Research, Inc
Greer, South Carolina, United States
Texas Diabetes and Endocrinology
Austin, Texas, United States
Tekton Research, Inc
Austin, Texas, United States
Texas Diabetes and Endocrinology, P.A.
Round Rock, Texas, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Universal Research Group, LLC
Tacoma, 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.
Brampton, , 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, , 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, , 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, , 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, , 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, , 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, , 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, , Canada
Research and Cardiovascular Corp.
Ponce, , Puerto Rico
Clinical Research Puerto Rico, Inc.
San Juan, , Puerto Rico
Countries
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Other Identifiers
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I7T-MC-RMAH
Identifier Type: OTHER
Identifier Source: secondary_id
15525
Identifier Type: -
Identifier Source: org_study_id
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