Phase 2
N=275
A Study of CIN-107 in Adults With Treatment-Resistant Hypertension (rHTN)
Resistant Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT04519658 ↗Enrolled (actual)
275
Serious AEs
3.7%
Results posted
Jun 2023
Primary outcome: Primary: Change From Baseline in Mean Seated Systolic BP (SBP) — -12.4; -17.3; -19.2; -9.8 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CIN-107 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- CinCor Pharma, Inc.
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Seated Systolic BP (SBP) |
-12.4; -17.3; -19.2; -9.8 | — |
| SECONDARY Change From Baseline in Mean Seated Diastolic BP (DBP) |
-9.1; -11.7; -14.0; -9.3 | — |
| SECONDARY The Percentage of Patients Achieving a Seated BP Response <130/80 mmHg |
21; 28; 26; 21 | — |
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).
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 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) 9.5% at Screening;
- Has planned dialysis or kidney transplant during the course of this study;
- 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.
Data sourced from ClinicalTrials.gov (NCT04519658). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.