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

Phase 2

Completed

• Conditions: Resistant Hypertension
• Interventions: Drug: Placebo; Drug: CIN-107

• Registration Number: NCT04519658
• Lead Sponsor: CinCor Pharma, Inc.

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-17
• Study First Submitted QC: 2020-08-17
• Study First Posted: 2020-08-20
• Study Start: 2020-10-12
• Primary Completion: 2022-06-14
• Study Completion: 2022-06-14
• Results First Submitted: 2023-06-07
• Results First Submitted QC: 2023-06-07
• Results First Posted: 2023-06-28
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-10
• Last Update Posted: 2023-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 275

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subjects received placebo tablets, administered orally once daily for 12 weeks. Subjects continued taking stable anti-hypertensive regimen throughout the study.
CIN-107 0.5mg	CIN-107	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.
CIN-107 2mg	CIN-107	Subjects received CIN-107 2 mg tablets, administered orally once daily for 12 weeks. Subjects continued taking stable anti-hypertensive regimen throughout the study.
CIN-107 1mg	CIN-107	Subjects received CIN-107 1 mg tablets, administered orally once daily for 12 weeks. Subjects continued taking stable anti-hypertensive regimen throughout the study.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Seated Systolic BP (SBP)	12 weeks

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Seated Diastolic BP (DBP)	12 weeks
The Percentage of Patients Achieving a Seated BP Response <130/80 mmHg	12 weeks

Trial Locations

Locations (80)

CinCor Site 16; 🇺🇸 Birmingham, Alabama, United States

CinCor Site 38; 🇺🇸 Birmingham, Alabama, United States

CinCor Site 61; 🇺🇸 Saraland, Alabama, United States

CinCor Site 90; 🇺🇸 Tucson, Arizona, United States

CinCor Site 82; 🇺🇸 Anaheim, California, United States

CinCor Site 91; 🇺🇸 Granada Hills, California, United States

CinCor Site 25; 🇺🇸 Lincoln, California, United States

CinCor Site 73; 🇺🇸 Los Angeles, California, United States

CinCor Site 36; 🇺🇸 Los Angeles, California, United States

CinCor Site 34; 🇺🇸 Lynwood, California, United States

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