Status:
COMPLETED
A Study of LY2623091 in Participants With High Blood Pressure
Lead Sponsor:
Eli Lilly and Company
Conditions:
Primary Hypertension
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT02194465
Start Date
August 1 2014
End Date
March 1 2015
Last Update
June 26 2020
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