A Study of LY2623091 in Participants With High Blood Pressure

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Mineralocorticoid Receptor Antagonists; Mineralocorticoids; Spironolactone; Tadalafil

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.