Clinical trial NCT05137002: A Study of CIN-107 in Patients With Uncontrolled Hypertension
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Uncontrolled Hypertension
Lead sponsor: CinCor Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2021-11-30
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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;

Primary outcomes:
measure: Change From Baseline in Mean Seated Systolic BP (SBP)
timeFrame: 8 weeks
Secondary outcomes:
measure: Change From Baseline in Mean Seated Diastolic BP (DBP)
timeFrame: 8 weeks
measure: Change From Baseline in 24-hour Urine Aldosterone
timeFrame: 8 weeks
measure: Change From Baseline in 24-hour Serum Aldosterone
timeFrame: 8 weeks
measure: Percentage of Patients Achieving a Mean Seated SBP <130 mmHg
timeFrame: 8 weeks
measure: Change From Baseline in 24-hour Urine Renin
timeFrame: 8 weeks
measure: Change From Baseline in 24-hour Serum Renin
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Saraland
country: United States
facility: CinCor Site 27
state: Alabama
city: Tucson
country: United States
facility: CinCor Site 35
state: Arizona
city: Encinitas
country: United States
facility: CinCor Site 69
state: California
city: Lincoln
country: United States
facility: CinCor Site 6
state: California
city: Los Angeles
country: United States
facility: CinCor Site 20
state: California
city: Lynwood
country: United States
facility: CinCor Site 70
state: California
city: Northridge
country: United States
facility: CinCor Site 36
state: California
city: Oceanside
country: United States
facility: CinCor Site 29
state: California
city: Panorama City
country: United States
facility: CinCor Site 46
state: California
city: San Dimas
country: United States
facility: CinCor Site 47
state: California
city: Santa Ana
country: United States
facility: CinCor Site 49
state: California
city: West Hills
country: United States
facility: CinCor Site 52
state: California
city: Denver
country: United States
facility: CinCor Site 57
state: Colorado
city: Waterbury
country: United States
facility: CinCor Site 31
state: Connecticut
city: Clearwater
country: United States
facility: CinCor Site 18
state: Florida
city: Cooper City
country: United States
facility: CinCor Site 41
state: Florida
city: Homestead
country: United States
facility: CinCor Site 28
state: Florida
city: Jupiter
country: United States
facility: CinCor Site 9
state: Florida
city: Lake Worth
country: United States
facility: CinCor Site 1
state: Florida
city: Miami
country: United States
facility: CinCor Site 12
state: Florida
city: Miami
country: United States
facility: CinCor Site 54
state: Florida
city: Miami
country: United States
facility: CinCor Site 13
state: Florida
city: Miami
country: United States
facility: CinCor Site 17
state: Florida
city: Tampa
country: United States
facility: CinCor Site 16
state: Florida
city: Winter Haven
country: United States
facility: CinCor Site 34
state: Florida
city: Buford
country: United States
facility: CinCor Site 14
state: Georgia
city: Addison
country: United States
facility: CinCor Site 33
state: Illinois
city: Chicago
country: United States
facility: CinCor Site 40
state: Illinois
city: Gurnee
country: United States
facility: CinCor Site 42
state: Illinois
city: Morton
country: United States
facility: CinCor Site 50
state: Illinois
city: Brownsburg
country: United States
facility: CinCor Site 72
state: Indiana
city: West Des Moines
country: United States
facility: CinCor Site 63
state: Iowa
city: Lexington
country: United States
facility: CinCor Site 7
state: Kentucky
city: Louisville
country: United States
facility: CinCor Site 21
state: Kentucky
city: Marrero
country: United States
facility: CinCor Site 30
state: Louisiana
city: Metairie
country: United States
facility: CinCor Site 59
state: Louisiana
city: New Orleans
country: United States
facility: CinCor Site 19
state: Louisiana
city: Shreveport
country: United States
facility: CinCor Site 25
state: Louisiana
city: Elkridge
country: United States
facility: CinCor Site 38
state: Maryland
city: Elkridge
country: United States
facility: CinCor Site 38
state: Maryland
city: Troy
country: United States
facility: CinCor Site 22
state: Michigan
city: Olive Branch
country: United States
facility: CinCor Site 64
state: Mississippi
city: Brooklyn
country: United States
facility: CinCor Site 11
state: New York
city: Staten Island
country: United States
facility: CinCor Site 65
state: New York
city: Cincinnati
country: United States
facility: CinCor Site 15
state: Ohio
city: Columbus
country: United States
facility: CinCor Site 24
state: Ohio
city: Dayton
country: United States
facility: CinCor Site 4
state: Ohio
city: Oklahoma City
country: United States
facility: CinCor Site 43
state: Oklahoma
city: Chattanooga
country: United States
facility: CinCor Site 60
state: Tennessee
city: Austin
country: United States
facility: CinCor Site 48
state: Texas
city: Carrollton
country: United States
facility: CinCor Site 32
state: Texas
city: Dallas
country: United States
facility: CinCor Site 68
state: Texas
city: Georgetown
country: United States
facility: CinCor Site 61
state: Texas
city: Houston
country: United States
facility: CinCor Site 55
state: Texas
city: Houston
country: United States
facility: CinCor Site 3
state: Texas
city: Katy
country: United States
facility: CinCor Site 58
state: Texas
city: Lampasas
country: United States
facility: CinCor Site 62
state: Texas
city: McAllen
country: United States
facility: CinCor Site 26
state: Texas
city: San Antonio
country: United States
facility: CinCor Site 53
state: Texas
city: Sugar Land
country: United States
facility: CinCor Site 10
state: Texas
city: Salt Lake City
country: United States
facility: CinCor Site 45
state: Utah
city: Manassas
country: United States
facility: CinCor Site 2
state: Virginia
city: Norfolk
country: United States
facility: CinCor Site 5
state: Virginia
Study officials:
References: