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

Resistant Hypertension Clinical Trial

— BrigHTN  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04519658
• Other study ID #: CIN-107-121
• Status: Completed
• Phase: Phase 2
• Start date: October 12, 2020
• Est. completion date: June 14, 2022

Study information

• Verified date: July 2023
• Source: CinCor Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 275
• Est. completion date: June 14, 2022
• Est. primary completion date: June 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Resistant Hypertension

Intervention

Drug:
• CIN-107
CIN-107 tablets by mouth once daily
• Placebo
placebo tablets by mouth once daily

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
CinCor Pharma, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Freeman MW, Halvorsen YD, Marshall W, Pater M, Isaacsohn J, Pearce C, Murphy B, Alp N, Srivastava A, Bhatt DL, Brown MJ; BrigHTN Investigators. Phase 2 Trial of Baxdrostat for Treatment-Resistant Hypertension. N Engl J Med. 2023 Feb 2;388(5):395-405. doi: 10.1056/NEJMoa2213169. Epub 2022 Nov 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Mean Seated Systolic BP (SBP)		12 weeks
Secondary	Change From Baseline in Mean Seated Diastolic BP (DBP)		12 weeks
Secondary	The Percentage of Patients Achieving a Seated BP Response <130/80 mmHg		12 weeks