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A Study of CIN-107 in Adults With Treatment-Resistant Hypertension (rHTN) (BrigHTN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04519658
Recruitment Status : Completed
First Posted : August 20, 2020
Last Update Posted : November 1, 2022
Sponsor:
Information provided by (Responsible Party):
CinCor Pharma, Inc.

Study Description
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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).

Condition or disease Intervention/treatment Phase
Resistant Hypertension Drug: CIN-107 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 348 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : October 12, 2020
Actual Primary Completion Date : June 14, 2022
Actual Study Completion Date : June 14, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: CIN-107 Dose 1 Drug: CIN-107
CIN-107 tablets by mouth once daily
Experimental: CIN-107 Dose 2 Drug: CIN-107
CIN-107 tablets by mouth once daily
Experimental: CIN-107 Dose 3 Drug: CIN-107
CIN-107 tablets by mouth once daily
Placebo Comparator: Placebo Drug: Placebo
placebo tablets by mouth once daily


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in mean seated systolic BP (SBP) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in mean seated diastolic BP (DBP) [ Time Frame: 12 weeks ]
  2. The percentage of patients achieving a seated BP response <130/80 mmHg [ Time Frame: 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04519658


Locations
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Sponsors and Collaborators
CinCor Pharma, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: CinCor Pharma, Inc.
ClinicalTrials.gov Identifier: NCT04519658    
Other Study ID Numbers: CIN-107-121
First Posted: August 20, 2020    Key Record Dates
Last Update Posted: November 1, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases