A Study of CIN-107 in Adults With Treatment-Resistant Hypertension (rHTN)
Completed · Phase 2 · Has a placebo group
Conditions studied: Resistant Hypertension
In brief
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).
Key facts
- Study ID
- NCT04519658
- Run by
- CinCor Pharma, Inc.
- People needed
- 275
- Starts
- 2020-10-12
- Expected to finish
- 2022-06-14
- Last updated by the study team
- 2023-07-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- 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
- CinCor Site 14 — San Dimas, California, United States
- CinCor Site 28 — Santa Ana, California, United States
- CinCor Site 19 — Spring Valley, California, United States
- CinCor Site 32 — Tustin, California, United States
- CinCor Site 44 — West Hills, California, United States
- CinCor Site 66 — Whittier, California, United States
- CinCor Site 56 — Stamford, Connecticut, United States
- CinCor Site 30 — Clearwater, Florida, United States
- CinCor Site 13 — Fort Myers, Florida, United States
- CinCor Site 74 — Hialeah, Florida, United States
- CinCor Site 22 — Homestead, Florida, United States
- CinCor Site 20 — Jacksonville, Florida, United States
- CinCor Site 1 — Jupiter, Florida, United States
- CinCor Site 84 — Lake Worth, Florida, United States
- CinCor Site 70 — Miami, Florida, United States
- CinCor Site 16 — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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