A Study of CIN-107 in Adults With Treatment-Resistant Hypertension (rHTN) (BrigHTN)

July 10, 2023 updated by: CinCor Pharma, Inc.

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of Multiple Dose Strengths of CIN-107 as Compared to Placebo After 12 Weeks of Treatment in Patients With Treatment-Resistant Hypertension (rHTN)

This is a randomized, double-blind, placebo-controlled, dose-ranging Phase 2 study to evaluate the efficacy and safety of CIN-107 as compared to placebo after 12 weeks of treatment in patients with treatment-resistant hypertension (rHTN).

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.
275

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

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • CinCor Site 16
      • Birmingham, Alabama, United States, 35294-0007
        • CinCor Site 38
      • Saraland, Alabama, United States, 36571
        • CinCor Site 61
    • Arizona
      • Tucson, Arizona, United States, 85715
        • CinCor Site 90
    • California
      • Anaheim, California, United States, 92805
        • CinCor Site 82
      • Granada Hills, California, United States, 91344
        • CinCor Site 91
      • Lincoln, California, United States, 95821
        • CinCor Site 25
      • Los Angeles, California, United States, 90048
        • CinCor Site 73
      • Los Angeles, California, United States, 90057
        • CinCor Site 36
      • Lynwood, California, United States, 90262
        • CinCor Site 34
      • San Dimas, California, United States, 91773
        • CinCor Site 14
      • Santa Ana, California, United States, 92705
        • CinCor Site 28
      • Spring Valley, California, United States, 91978
        • CinCor Site 19
      • Tustin, California, United States, 92780
        • CinCor Site 32
      • West Hills, California, United States, 91405
        • CinCor Site 44
      • Whittier, California, United States, 90211
        • CinCor Site 66
    • Connecticut
      • Stamford, Connecticut, United States, 06905
        • CinCor Site 56
    • Florida
      • Clearwater, Florida, United States, 33765
        • CinCor Site 30
      • Fort Myers, Florida, United States, 33912
        • CinCor Site 13
      • Hialeah, Florida, United States, 33013
        • CinCor Site 74
      • Homestead, Florida, United States, 33166
        • CinCor Site 22
      • Jacksonville, Florida, United States, 32216
        • CinCor Site 20
      • Jupiter, Florida, United States, 33458
        • CinCor Site 1
      • Lake Worth, Florida, United States, 33467
        • CinCor Site 84
      • Miami, Florida, United States, 33012
        • CinCor Site 70
      • Miami, Florida, United States, 33032
        • CinCor Site 89
      • Miami, Florida, United States, 33033
        • CinCor Site 94
      • Port Orange, Florida, United States, 32127
        • CinCor Site 5
      • Saint Petersburg, Florida, United States, 33709
        • CinCor Site 9
      • Tampa, Florida, United States, 33606
        • CinCor Site 23
      • Winter Haven, Florida, United States, 33880
        • CinCor Site 88
    • Georgia
      • Suwanee, Georgia, United States, 30024
        • CinCor Site 71
    • Idaho
      • Meridian, Idaho, United States, 83642
        • CinCor Site 11
    • Illinois
      • Addison, Illinois, United States, 60101
        • CinCor Site 15
      • Arlington Heights, Illinois, United States, 60005
        • CinCor Site 81
      • Chicago, Illinois, United States, 60607
        • CinCor Site 49
      • Morton, Illinois, United States, 61550
        • CinCor Site 35
    • Indiana
      • Evansville, Indiana, United States, 47714
        • CinCor Site 58
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • CinCor Site 54
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • CinCor Site 29
      • Lexington, Kentucky, United States, 40509
        • CinCor Site 24
    • Louisiana
      • New Orleans, Louisiana, United States, 70119
        • CinCor Site 69
      • Shreveport, Louisiana, United States, 71101
        • CinCor Site 64
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • CinCor Site 75
      • Elkridge, Maryland, United States, 21075
        • CinCor Site 65
    • Michigan
      • Roseville, Michigan, United States, 48066
        • CinCor Site 52
      • Troy, Michigan, United States, 48085
        • CinCor Site 21
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • CinCor Site 92
      • Olive Branch, Mississippi, United States, 38654
        • CinCor Site 50
    • Montana
      • Butte, Montana, United States, 59701
        • CinCor Site 45
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • CinCor Site 47
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • CinCor Site 31
    • New York
      • Bronx, New York, United States, 10455
        • CinCor Site 4
      • Johnson City, New York, United States, 13901
        • CinCor Site 55
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • CinCor Site 59
      • Cincinnati, Ohio, United States, 45246
        • CinCor Site 6
      • Cincinnati, Ohio, United States, 45246
        • CinCor Site 7
      • Dayton, Ohio, United States, 45439
        • CinCor Site 86
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15066
        • CinCor Site 43
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29588
        • CinCor Site 39
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • CinCor Site 97
      • Knoxville, Tennessee, United States, 37920
        • CinCor Site 42
    • Texas
      • Austin, Texas, United States, 78705
        • CinCor Site 27
      • Carrollton, Texas, United States, 75006
        • CinCor Site 80
      • Dallas, Texas, United States, 75234
        • CinCor Site 79
      • Friendswood, Texas, United States, 77089
        • CinCor Site 87
      • Houston, Texas, United States, 77040
        • CinCor Site 2
      • Houston, Texas, United States, 77054
        • CinCor Site 72
      • Hurst, Texas, United States, 76054
        • CinCor Site 46
      • Kerville, Texas, United States, 78028
        • CinCor Site 93
      • McAllen, Texas, United States, 78503
        • CinCor Site 37
      • Sugar Land, Texas, United States, 77479
        • CinCor Site 85
    • Utah
      • Draper, Utah, United States, 84020
        • CinCor Site 48
      • Salt Lake City, Utah, United States, 84107
        • CinCor Site 3
    • Virginia
      • Alexandria, Virginia, United States, 22304
        • CinCor Site 77
      • Burke, Virginia, United States, 22015
        • CinCor Site 8
      • Manassas, Virginia, United States, 20110
        • CinCor Site 33
      • Norfolk, Virginia, United States, 23510
        • CinCor Site 76
    • Washington
      • Olympia, Washington, United States, 98502
        • CinCor Site 41
    • Wisconsin
      • Kenosha, Wisconsin, United States, 60031
        • CinCor Site 51

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Is on a stable regimen of ≥ 3 antihypertensive agents (one of which is a diuretic) for at least 4 weeks prior to randomization;
  • Be at least 70% compliant to their anti-hypertensive medication regimen;
  • Has a seated BP ≥ 130/80 mmHg;
  • Agrees to comply with the contraception and reproduction restrictions of the study; and
  • Able to understand and willing to comply with all study visits, procedures, restrictions, and provide written informed consent according to institutional and regulatory guidelines.

Exclusion Criteria:

  • Has a seated SBP ≥ 180 mmHg or DBP ≥ 110 mmHg;
  • Has a body mass index (BMI) > 40 kg/m2;
  • Has an upper arm circumference < 7 or > 17 inches;
  • Has been on night shifts at any time during the 4 weeks before Screening;
  • Is using a beta blocker for any primary indication other than systemic hypertension (eg, migraine headache);
  • Is not willing or not able to discontinue an MRA or a potassium sparing diuretic as part of an existing antihypertensive regimen;
  • Is not willing or not able to discontinue taking a potassium supplement;
  • Has documented estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73m2
  • Has known and documented New York Heart Association stage III or IV chronic heart failure
  • Has had a stroke, transient ischemic attack, hypertensive encephalopathy, acute coronary syndrome, or hospitalization for heart failure within 6 months before Screening;
  • Has known current severe left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy and/or severe aortic valvular disease diagnosed from a prior echocardiogram;
  • Major cardiac surgery (eg, CABG, valve replacement), peripheral arterial bypass surgery, or PCI within 6 months before Screening;
  • Has chronic permanent atrial fibrillation;
  • Has uncontrolled diabetes with glycosylated hemoglobin > 9.5% at Screening;
  • Has planned dialysis or kidney transplant during the course of this study;
  • Potassium < 3.5 mEq/L;
  • Potassium > 5.0 mEq/L;
  • Is positive for HIV antibody, hepatitis C virus RNA, or hepatitis B surface antigen;
  • Has typical consumption of ≥14 alcoholic drinks weekly.

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: Quadruple

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: CIN-107 0.5mg
Subjects received CIN-107 0.5 mg tablets, administered orally once daily for 12 weeks. Subjects continued taking stable anti-hypertensive regimen throughout the study.
Drug: CIN-107
CIN-107 tablets by mouth once daily
Other Names:
  • baxdrostat
Experimental: CIN-107 1mg
Subjects received CIN-107 1 mg tablets, administered orally once daily for 12 weeks. Subjects continued taking stable anti-hypertensive regimen throughout the study.
Drug: CIN-107
CIN-107 tablets by mouth once daily
Other Names:
  • baxdrostat
Experimental: CIN-107 2mg
Subjects received CIN-107 2 mg tablets, administered orally once daily for 12 weeks. Subjects continued taking stable anti-hypertensive regimen throughout the study.
Drug: CIN-107
CIN-107 tablets by mouth once daily
Other Names:
  • baxdrostat
Placebo Comparator: Placebo
Subjects received placebo tablets, administered orally once daily for 12 weeks. Subjects continued taking stable anti-hypertensive regimen throughout the study.
Drug: Placebo
placebo tablets by mouth once daily

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
Time Frame
Change From Baseline in Mean Seated Systolic BP (SBP)
Time Frame: 12 weeks
12 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
Time Frame
Change From Baseline in Mean Seated Diastolic BP (DBP)
Time Frame: 12 weeks
12 weeks
The Percentage of Patients Achieving a Seated BP Response <130/80 mmHg
Time Frame: 12 weeks
12 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.
CinCor Pharma, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

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.
October 12, 2020

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.
June 14, 2022

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.
June 14, 2022

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).
August 17, 2020

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.
August 17, 2020

First Posted (Actual)

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.
August 20, 2020

Study Record Updates

Last Update Posted (Estimated)

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.
July 24, 2023

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.
July 10, 2023

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.
July 1, 2023

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.
  • CIN-107-121

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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