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A Study of LY2623091 in Participants With High Blood Pressure

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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

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

Trial contacts and locations

43

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Data sourced from clinicaltrials.gov

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