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Completed

NCT Number: NCT04519658

A Study of CIN-107 in Adults 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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CinCor Site 16, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

CIN-107

Drug

CIN-107 tablets by mouth once daily

Other names: baxdrostat

Placebo

Drug

placebo tablets by mouth once daily

Primary outcomes

  1. Change From Baseline in Mean Seated Systolic BP (SBP)

    Time frame: 12 weeks

Secondary outcomes

  1. Change From Baseline in Mean Seated Diastolic BP (DBP)

    Time frame: 12 weeks

  2. The Percentage of Patients Achieving a Seated BP Response <130/80 mmHg

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

CinCor Pharma, Inc.

Industry

Registry information

Official study title

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)

Acronym: BrigHTN

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 20, 2020
Registry last updated
Jul 24, 2023

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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