A Study of CIN-107 in Adults With Treatment-Resistant Hypertension (rHTN)
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 275
- 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.
- 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 89
🇺🇸Miami, Florida, United States
CinCor Site 47
🇺🇸Las Vegas, Nevada, United States
CinCor Site 7
🇺🇸Cincinnati, Ohio, United States
CinCor Site 59
🇺🇸Cincinnati, Ohio, United States
CinCor Site 45
🇺🇸Butte, Montana, United States
CinCor Site 3
🇺🇸Salt Lake City, Utah, United States
CinCor Site 70
🇺🇸Miami, Florida, United States
CinCor Site 19
🇺🇸Spring Valley, California, United States
CinCor Site 66
🇺🇸Whittier, California, United States
CinCor Site 91
🇺🇸Granada Hills, California, United States
CinCor Site 22
🇺🇸Homestead, Florida, United States
CinCor Site 13
🇺🇸Fort Myers, Florida, United States
CinCor Site 90
🇺🇸Tucson, Arizona, United States
CinCor Site 73
🇺🇸Los Angeles, California, United States
CinCor Site 61
🇺🇸Saraland, Alabama, United States
CinCor Site 34
🇺🇸Lynwood, California, United States
CinCor Site 36
🇺🇸Los Angeles, California, United States
CinCor Site 14
🇺🇸San Dimas, California, United States
CinCor Site 28
🇺🇸Santa Ana, California, United States
CinCor Site 56
🇺🇸Stamford, Connecticut, United States
CinCor Site 74
🇺🇸Hialeah, Florida, United States
CinCor Site 84
🇺🇸Lake Worth, Florida, United States
CinCor Site 9
🇺🇸Saint Petersburg, Florida, United States
CinCor Site 71
🇺🇸Suwanee, Georgia, United States
CinCor Site 11
🇺🇸Meridian, Idaho, United States
CinCor Site 52
🇺🇸Roseville, Michigan, United States
CinCor Site 35
🇺🇸Morton, Illinois, United States
CinCor Site 80
🇺🇸Carrollton, Texas, United States
CinCor Site 8
🇺🇸Burke, Virginia, United States
CinCor Site 64
🇺🇸Shreveport, Louisiana, United States
CinCor Site 65
🇺🇸Elkridge, Maryland, United States
CinCor Site 50
🇺🇸Olive Branch, Mississippi, United States
CinCor Site 92
🇺🇸Hattiesburg, Mississippi, United States
CinCor Site 54
🇺🇸West Des Moines, Iowa, United States
CinCor Site 75
🇺🇸Baltimore, Maryland, United States
CinCor Site 21
🇺🇸Troy, Michigan, United States
CinCor Site 85
🇺🇸Sugar Land, Texas, United States
CinCor Site 6
🇺🇸Cincinnati, Ohio, United States
CinCor Site 55
🇺🇸Johnson City, New York, United States
CinCor Site 97
🇺🇸Jackson, Tennessee, United States
CinCor Site 87
🇺🇸Friendswood, Texas, United States
CinCor Site 33
🇺🇸Manassas, Virginia, United States
CinCor Site 79
🇺🇸Dallas, Texas, United States
CinCor Site 48
🇺🇸Draper, Utah, United States
CinCor Site 42
🇺🇸Knoxville, Tennessee, United States
CinCor Site 72
🇺🇸Houston, Texas, United States
CinCor Site 51
🇺🇸Kenosha, Wisconsin, United States
CinCor Site 77
🇺🇸Alexandria, Virginia, United States
CinCor Site 16
🇺🇸Birmingham, Alabama, United States
CinCor Site 38
🇺🇸Birmingham, Alabama, United States
CinCor Site 2
🇺🇸Houston, Texas, United States
CinCor Site 76
🇺🇸Norfolk, Virginia, United States
CinCor Site 15
🇺🇸Addison, Illinois, United States
CinCor Site 82
🇺🇸Anaheim, California, United States
CinCor Site 25
🇺🇸Lincoln, California, United States
CinCor Site 32
🇺🇸Tustin, California, United States
CinCor Site 30
🇺🇸Clearwater, Florida, United States
CinCor Site 44
🇺🇸West Hills, California, United States
CinCor Site 20
🇺🇸Jacksonville, Florida, United States
CinCor Site 1
🇺🇸Jupiter, Florida, United States
CinCor Site 94
🇺🇸Miami, Florida, United States
CinCor Site 5
🇺🇸Port Orange, Florida, United States
CinCor Site 49
🇺🇸Chicago, Illinois, United States
CinCor Site 88
🇺🇸Winter Haven, Florida, United States
CinCor Site 81
🇺🇸Arlington Heights, Illinois, United States
CinCor Site 58
🇺🇸Evansville, Indiana, United States
CinCor Site 86
🇺🇸Dayton, Ohio, United States
CinCor Site 39
🇺🇸Myrtle Beach, South Carolina, United States
CinCor Site 43
🇺🇸Beaver, Pennsylvania, United States
CinCor Site 37
🇺🇸McAllen, Texas, United States
CinCor Site 46
🇺🇸Hurst, Texas, United States
CinCor Site 93
🇺🇸Kerville, Texas, United States
CinCor Site 41
🇺🇸Olympia, Washington, United States
CinCor Site 23
🇺🇸Tampa, Florida, United States
CinCor Site 29
🇺🇸Lexington, Kentucky, United States
CinCor Site 24
🇺🇸Lexington, Kentucky, United States
CinCor Site 69
🇺🇸New Orleans, Louisiana, United States
CinCor Site 31
🇺🇸Albuquerque, New Mexico, United States
CinCor Site 4
🇺🇸Bronx, New York, United States
CinCor Site 27
🇺🇸Austin, Texas, United States