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OpenTrials
Completed

NCT Number: NCT02194465

A Study of LY2623091 in Participants With High Blood Pressure

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LY2623091

Drug

Administered orally

Other names: Mineralocorticoid Receptor Antagonist

Tadalafil

Drug

Administered orally

Other names: LY450190

Spironolactone

Drug

Administered orally

Placebo

Drug

Administered orally

Primary outcomes

  1. Change From Baseline to 4 Weeks in Seated Systolic Blood Pressure (SBP)

    Time frame: Baseline, 4 Weeks

    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.

Secondary outcomes

  1. Change From Baseline to 4 Weeks in Seated Diastolic Blood Pressure (DBP)

    Time frame: Baseline, 4 Weeks

    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.

  2. Change From Baseline to 4 Weeks in 24 Hour Ambulatory Blood Pressure Monitoring (ABPM)

    Time frame: Baseline, 4 Weeks

    The LS mean change in blood pressure is calculated after adjusting for baseline, treatment and race using an analysis of covariance (ANCOVA).

  3. Change From Baseline to 4 Weeks in Serum Potassium

    Time frame: Baseline, 4 Weeks

    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.

  4. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2623091

    Time frame: 2 hours post-dose at 4 Weeks

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Randomized, Placebo-Controlled, Double-Blinded, Parallel, Phase 2a Study to Evaluate the Safety and Efficacy of LY2623091 in Patients With Primary Hypertension

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 18, 2014
Registry last updated
Jun 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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