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)
Overview
- Phase
- Phase 2
- Intervention
- CIN-107
- Conditions
- Resistant Hypertension
- Sponsor
- CinCor Pharma, Inc.
- Enrollment
- 275
- Locations
- 80
- Primary Endpoint
- Change From Baseline in Mean Seated Systolic BP (SBP)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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).
Investigators
Eligibility Criteria
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;
Arms & Interventions
CIN-107 0.5mg
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.
Intervention: CIN-107
CIN-107 1mg
Subjects received CIN-107 1 mg tablets, administered orally once daily for 12 weeks. Subjects continued taking stable anti-hypertensive regimen throughout the study.
Intervention: CIN-107
CIN-107 2mg
Subjects received CIN-107 2 mg tablets, administered orally once daily for 12 weeks. Subjects continued taking stable anti-hypertensive regimen throughout the study.
Intervention: CIN-107
Placebo
Subjects received placebo tablets, administered orally once daily for 12 weeks. Subjects continued taking stable anti-hypertensive regimen throughout the study.
Intervention: Placebo
Outcomes
Primary Outcomes
Change From Baseline in Mean Seated Systolic BP (SBP)
Time Frame: 12 weeks
Secondary Outcomes
- 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)