Status:
COMPLETED
A Study of CIN-107 in Adults With Treatment-Resistant Hypertension (rHTN)
Lead Sponsor:
CinCor Pharma, Inc.
Conditions:
Resistant Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 tr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 14 2022
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT04519658
Start Date
October 12 2020
End Date
June 14 2022
Last Update
July 24 2023
Active Locations (80)
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1
CinCor Site 16
Birmingham, Alabama, United States, 35209
2
CinCor Site 38
Birmingham, Alabama, United States, 35294-0007
3
CinCor Site 61
Saraland, Alabama, United States, 36571
4
CinCor Site 90
Tucson, Arizona, United States, 85715