Primary Hypertension Clinical Trial
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
| Verified date | June 2020 |
| Source | Eli Lilly and Company |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 304 |
| Est. completion date | March 2015 |
| Est. primary completion date | March 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| 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. | 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. | Quebec City | |
| 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 | |
| Puerto Rico | Research and Cardiovascular Corp. | Ponce | |
| Puerto Rico | Clinical Research Puerto Rico, Inc. | San Juan | |
| United States | Northwest Heart Clinical Research, LLC | Arlington Heights | Illinois |
| United States | Maine Research Associates | Auburn | Maine |
| United States | Tekton Research, Inc | Austin | Texas |
| United States | Texas Diabetes and Endocrinology | Austin | Texas |
| United States | Northwest Clinical Research Center | Bellevue | Washington |
| United States | Grace Research | Bossier City | Louisiana |
| United States | Metrolina Internal Medicine, P.A. | Charlotte | North Carolina |
| United States | Cedar-Crosse Research Center | Chicago | Illinois |
| 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 | John Muir Health Network - The Osteoporosis Center | Concord | California |
| United States | Dayton Clinical Research | Dayton | Ohio |
| United States | Avail Clinical Research LLC | DeLand | Florida |
| United States | Encompass Clinical Research | Encinitas | California |
| United States | Lillestol Research LLC | Fargo | North Dakota |
| United States | Alan Graff, MD, PA | Fort Lauderdale | Florida |
| United States | Clinical Research Advantage | Glendale | Arizona |
| United States | PharmQuest | Greensboro | North Carolina |
| United States | Mountain View Clinical Research, Inc | Greer | South Carolina |
| United States | East West Medical Institute | Honolulu | Hawaii |
| United States | Rocky Mountain Diabetes and Osteoporosis Center | Idaho Falls | Idaho |
| United States | Midwest Institute for Clinical Research | Indianapolis | Indiana |
| United States | Jacksonville Center for Clinical Research | Jacksonville | Florida |
| United States | AB Clinical Trials | Las Vegas | Nevada |
| United States | Community Clinical Research Center | Muncie | Indiana |
| United States | Cor Clinical Research LLC | Oklahoma City | Oklahoma |
| United States | Oklahoma Foundation For Cardiovascular Research | Oklahoma City | Oklahoma |
| United States | Rochester Clinical Research, Inc. | Rochester | New York |
| United States | Texas Diabetes and Endocrinology, P.A. | Round Rock | Texas |
| United States | Cardiovascular Center of Sarasota | Sarasota | Florida |
| United States | Universal Research Group, LLC | Tacoma | Washington |
| United States | Heartland Research Associates | Wichita | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company |
United States, Canada, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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. | Baseline, 4 Weeks | |
| 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. | Baseline, 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). | Baseline, 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. | Baseline, 4 Weeks | |
| Secondary | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2623091 | 2 hours post-dose at 4 Weeks |
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