A Study of LY2623091 in Participants With High Blood Pressure

Lilly

Status and phase: Completed; Phase 2

Conditions: Primary Hypertension

Treatments: Drug: Spironolactone; Drug: LY2623091; Drug: Tadalafil; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02194465

15525

I7T-MC-RMAH (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 304 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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304 participants in 7 patient groups, including a placebo group

6 milligrams (mg) LY2623091

Experimental group

Description:

6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.

Treatment:

Drug: Placebo

Drug: LY2623091

13 mg LY2623091

Experimental group

Description:

13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.

Treatment:

Drug: Placebo

Drug: LY2623091

24.5 mg LY2623091

Experimental group

Description:

24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.

Treatment:

Drug: Placebo

Drug: LY2623091

13 mg LY2623091 + 20 mg tadalafil

Experimental group

Description:

13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks.

Treatment:

Drug: Placebo

Drug: Tadalafil

Drug: LY2623091

20 mg tadalafil

Experimental group

Description:

20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks.

Treatment:

Drug: Placebo

Drug: Tadalafil

Spironolactone

Active Comparator group

Description:

25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.

Treatment:

Drug: Spironolactone

Placebo

Placebo Comparator group

Description:

Placebo for blinding administered orally once daily for 4 weeks.

Treatment:

Drug: Placebo