A Study of CIN-107 in Patients With Uncontrolled Hypertension

Uncontrolled Hypertension Clinical Trial

— HALO  

Official title:

A Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Multiple Dose Strengths of CIN-107 as Compared to Placebo After 8 Weeks of Treatment in Patients With Uncontrolled Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05137002
• Other study ID #: CIN-107-124
• Status: Completed
• Phase: Phase 2
• Start date: December 7, 2021
• Est. completion date: October 10, 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 Phase 2, randomized, multicenter study to evaluate the efficacy and safety of multiple dose strengths of baxdrostat (also called CIN-107) in the treatment of patients with uncontrolled hypertension. The primary objective was to demonstrate that treatment with baxdrostat for 8 weeks would lower the systolic blood pressure (SBP) in patients who were hypertensive despite taking one or two anti-hypertensive medications.

Participants were assigned to take placebo or baxdrostat once per day for 8 weeks while they continued taking the regular anti-hypertensive medications. At the end of the 8-week period, qualified patients could participate in Part II of the study and receive 2 mg baxdrostat for 4 weeks while they discontinued taking the background anti-hypertensive medication.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Est. completion date: October 10, 2022
• Est. primary completion date: September 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Is on a stable regimen of background antihypertensive agent(s) for at least 8 weeks and would be considered a candidate for an additional antihypertensive agent at the time of screening ;

• Has a mean seated systolic blood pressure (SBP) = 140 mmHg or = 130 mmHg if diabetic;

• Demonstrates ability to be adherent to the study drug and their anti-hypertensive medication during a run-in period

• If taking an SGLT2 inhibitor, the regimen must be stable for at least 8 weeks prior to randomization; and

• Agrees to comply with the contraception and reproduction restrictions of the study;

Exclusion Criteria:

• Has a mean seated systolic blood pressure (SBP) =180 mmHG;

• Has a body mass index (BMI) >50 kg/m2;

• Is using alpha or beta blockers for any primary indication other than systemic hypertension (eg, migraine headache);

• Is not willing or not able to discontinue an MRA or potassium sparing diuretic as part of an existing antihypertensive regimen;

• Has documented estimated eGFR <30 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;

• Major cardiac surgery within 6 months before Screening;

• Has chronic permanent atrial fibrillation;

• Has uncontrolled diabetes with glycated hemoglobin >10% at Screening;

• Has planned dialysis or kidney transplantation planned during the course of the study;

• Prior solid organ transplant and/or cell transplants;

• Sodium <130 mEq/L;

• Potassium <3.5 mEq/L;

• Potassium >5 mEq/L;

• White blood cell count >15 × E9/L or absolute neutrophil count <1 × E9/L at Screening;

• 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
• Uncontrolled 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 33	Addison	Illinois
United States	CinCor Site 48	Austin	Texas
United States	CinCor Site 11	Brooklyn	New York
United States	CinCor Site 72	Brownsburg	Indiana
United States	CinCor Site 14	Buford	Georgia
United States	CinCor Site 32	Carrollton	Texas
United States	CinCor Site 60	Chattanooga	Tennessee
United States	CinCor Site 40	Chicago	Illinois
United States	CinCor Site 15	Cincinnati	Ohio
United States	CinCor Site 18	Clearwater	Florida
United States	CinCor Site 24	Columbus	Ohio
United States	CinCor Site 41	Cooper City	Florida
United States	CinCor Site 68	Dallas	Texas
United States	CinCor Site 4	Dayton	Ohio
United States	CinCor Site 57	Denver	Colorado
United States	CinCor Site 38	Elkridge	Maryland
United States	CinCor Site 38	Elkridge	Maryland
United States	CinCor Site 69	Encinitas	California
United States	CinCor Site 61	Georgetown	Texas
United States	CinCor Site 42	Gurnee	Illinois
United States	CinCor Site 28	Homestead	Florida
United States	CinCor Site 3	Houston	Texas
United States	CinCor Site 55	Houston	Texas
United States	CinCor Site 9	Jupiter	Florida
United States	CinCor Site 58	Katy	Texas
United States	CinCor Site 1	Lake Worth	Florida
United States	CinCor Site 62	Lampasas	Texas
United States	CinCor Site 7	Lexington	Kentucky
United States	CinCor Site 6	Lincoln	California
United States	CinCor Site 20	Los Angeles	California
United States	CinCor Site 21	Louisville	Kentucky
United States	CinCor Site 70	Lynwood	California
United States	CinCor Site 2	Manassas	Virginia
United States	CinCor Site 30	Marrero	Louisiana
United States	CinCor Site 26	McAllen	Texas
United States	CinCor Site 59	Metairie	Louisiana
United States	CinCor Site 12	Miami	Florida
United States	CinCor Site 13	Miami	Florida
United States	CinCor Site 17	Miami	Florida
United States	CinCor Site 54	Miami	Florida
United States	CinCor Site 50	Morton	Illinois
United States	CinCor Site 19	New Orleans	Louisiana
United States	CinCor Site 5	Norfolk	Virginia
United States	CinCor Site 36	Northridge	California
United States	CinCor Site 29	Oceanside	California
United States	CinCor Site 43	Oklahoma City	Oklahoma
United States	CinCor Site 64	Olive Branch	Mississippi
United States	CinCor Site 46	Panorama City	California
United States	CinCor Site 45	Salt Lake City	Utah
United States	CinCor Site 53	San Antonio	Texas
United States	CinCor Site 47	San Dimas	California
United States	CinCor Site 49	Santa Ana	California
United States	CinCor Site 27	Saraland	Alabama
United States	CinCor Site 25	Shreveport	Louisiana
United States	CinCor Site 65	Staten Island	New York
United States	CinCor Site 10	Sugar Land	Texas
United States	CinCor Site 16	Tampa	Florida
United States	CinCor Site 22	Troy	Michigan
United States	CinCor Site 35	Tucson	Arizona
United States	CinCor Site 31	Waterbury	Connecticut
United States	CinCor Site 63	West Des Moines	Iowa
United States	CinCor Site 52	West Hills	California
United States	CinCor Site 34	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
CinCor Pharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Mean Seated Systolic BP (SBP)	The primary efficacy endpoint was the change from baseline in mean seated SBP after 8 weeks of treatment in patients with uncontrolled HTN (Part 1).	8 weeks
Secondary	Change From Baseline in Mean Seated Diastolic BP (DBP)	The change from baseline in mean seated DBP with CIN-107 compared to placebo after 8 weeks of treatment (Part 1)	8 weeks
Secondary	Change From Baseline in 24-hour Urine Aldosterone	The change from baseline in 24-hour urine aldosterone levels with CIN 107 compared to placebo after 8 weeks of treatment (Part 1)	8 weeks
Secondary	Change From Baseline in 24-hour Serum Aldosterone	The change from baseline in 24-hour serum aldosterone levels with CIN 107 compared to placebo after 8 weeks of treatment (Part 1)	8 weeks
Secondary	Percentage of Patients Achieving a Mean Seated SBP <130 mmHg	The percentage of patients achieving a mean seated SBP <130 mmHg ("responders") with CIN-107 compared to placebo after 8 weeks of treatment (Part 1; Weeks 1 to 8)	8 weeks
Secondary	Change From Baseline in 24-hour Urine Renin	The change from baseline in 24-hour urine renin levels with CIN-107 compared to placebo after 8 weeks of treatment (Part 1)	8 weeks
Secondary	Change From Baseline in 24-hour Serum Renin	The change from baseline in 24-hour serum renin levels with CIN-107 compared to placebo after 8 weeks of treatment (Part 1)	8 weeks