A Study of LY2623091 in Participants With High Blood Pressure

June 9, 2020 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
304

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Brampton, Canada, L6T 0G1
        • 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.
      • Kelowna, Canada, V1Y3G8
        • 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.
      • Peterborough, Canada, K9J 0B2
        • 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.
      • Pointe Claire, Canada, H9R 4S3
        • 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.
      • Quebec City, Canada, G1N 4V3
        • 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.
      • Red Deer, Canada, T4N 6V7
        • 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.
      • Sherbrooke, Canada, J1J 2G2
        • 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.
      • Toronto, Canada, M9W 4L6
        • 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.
  • Puerto Rico
      • Ponce, Puerto Rico, 00717-1322
        • Research and Cardiovascular Corp.
      • San Juan, Puerto Rico, 00909
        • Clinical Research Puerto Rico, Inc.
  • United States
    • Arizona
      • Glendale, Arizona, United States, 85306
        • Clinical Research Advantage
    • California
      • Concord, California, United States, 94520
        • John Muir Health Network - The Osteoporosis Center
      • Encinitas, California, United States, 92024
        • Encompass Clinical Research
    • Florida
      • DeLand, Florida, United States, 32720
        • Avail Clinical Research LLC
      • Fort Lauderdale, Florida, United States, 33308
        • Alan Graff, MD, PA
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical Research
      • Sarasota, Florida, United States, 34239
        • Cardiovascular Center of Sarasota
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • East West Medical Institute
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Rocky Mountain Diabetes and Osteoporosis Center
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Northwest Heart Clinical Research, LLC
      • Chicago, Illinois, United States, 60607
        • Cedar-Crosse Research Center
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Midwest Institute for Clinical Research
      • Muncie, Indiana, United States, 47304
        • Community Clinical Research Center
    • Kansas
      • Wichita, Kansas, United States, 67207
        • Heartland Research Associates
    • Louisiana
      • Bossier City, Louisiana, United States, 71111
        • Grace Research
    • Maine
      • Auburn, Maine, United States, 04210
        • Maine Research Associates
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • AB Clinical Trials
    • New York
      • Rochester, New York, United States, 14609
        • Rochester Clinical Research, Inc.
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Metrolina Internal Medicine, P.A.
      • Greensboro, North Carolina, United States, 27408
        • PharmQuest
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Lillestol Research LLC
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Sterling Research Group, Ltd
      • Cleveland, Ohio, United States, 44122
        • Rapid Medical Research Inc
      • Columbus, Ohio, United States, 43213
        • Columbus Clinical Research
      • Dayton, Ohio, United States, 45406
        • Dayton Clinical Research
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Oklahoma Foundation for Cardiovascular Research
      • Oklahoma City, Oklahoma, United States, 4052728481
        • COR Clinical Research LLC
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Mountain View Clinical Research, Inc
    • Texas
      • Austin, Texas, United States, 78745
        • Tekton Research, Inc
      • Austin, Texas, United States, 78731-4309
        • Texas Diabetes and Endocrinology
      • Round Rock, Texas, United States, 78681
        • Texas Diabetes and Endocrinology, P.A.
    • Washington
      • Bellevue, Washington, United States, 98007-4209
        • Northwest Clinical Research Center
      • Tacoma, Washington, United States, 98405
        • Universal Research Group, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 6 milligrams (mg) LY2623091
6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
Drug: Placebo
Administered orally
Drug: LY2623091
Administered orally
Other Names:
  • Mineralocorticoid Receptor Antagonist
Experimental: 13 mg LY2623091
13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
Drug: Placebo
Administered orally
Drug: LY2623091
Administered orally
Other Names:
  • Mineralocorticoid Receptor Antagonist
Experimental: 24.5 mg LY2623091
24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
Drug: Placebo
Administered orally
Drug: LY2623091
Administered orally
Other Names:
  • Mineralocorticoid Receptor Antagonist
Experimental: 13 mg LY2623091 + 20 mg tadalafil
13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks.
Drug: Placebo
Administered orally
Drug: Tadalafil
Administered orally
Other Names:
  • LY450190
Drug: LY2623091
Administered orally
Other Names:
  • Mineralocorticoid Receptor Antagonist
Experimental: 20 mg tadalafil
20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks.
Drug: Placebo
Administered orally
Drug: Tadalafil
Administered orally
Other Names:
  • LY450190
Active Comparator: Spironolactone
25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.
Drug: Spironolactone
Administered orally
Placebo Comparator: Placebo
Placebo for blinding administered orally once daily for 4 weeks.
Drug: Placebo
Administered orally

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 4 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 4 Weeks
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).
Baseline, 4 Weeks
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.
Baseline, 4 Weeks
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2623091
Time Frame: 2 hours post-dose at 4 Weeks
2 hours post-dose at 4 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15525
  • I7T-MC-RMAH (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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