A Study of CIN-107 in Patients With Uncontrolled Hypertension
- Registration Number
- NCT05137002
- Lead Sponsor
- CinCor Pharma, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 249
- 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;
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2mg) and discontinue their background antihypertensive agent(s) for 4 weeks CIN-107 0.5 mg CIN-107 Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks CIN-107 2 mg CIN-107 Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient may remain on CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks or withdraw study participation depending on BP control CIN-107 1 mg CIN-107 Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks
- Primary Outcome Measures
Name Time Method Change From Baseline in Mean Seated Systolic BP (SBP) 8 weeks 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).
- Secondary Outcome Measures
Name Time Method Change From Baseline in Mean Seated Diastolic BP (DBP) 8 weeks The change from baseline in mean seated DBP with CIN-107 compared to placebo after 8 weeks of treatment (Part 1)
Change From Baseline in 24-hour Urine Aldosterone 8 weeks The change from baseline in 24-hour urine aldosterone levels with CIN 107 compared to placebo after 8 weeks of treatment (Part 1)
Change From Baseline in 24-hour Serum Renin 8 weeks The change from baseline in 24-hour serum renin levels with CIN-107 compared to placebo after 8 weeks of treatment (Part 1)
Change From Baseline in 24-hour Serum Aldosterone 8 weeks The change from baseline in 24-hour serum aldosterone levels with CIN 107 compared to placebo after 8 weeks of treatment (Part 1)
Percentage of Patients Achieving a Mean Seated SBP <130 mmHg 8 weeks 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)
Change From Baseline in 24-hour Urine Renin 8 weeks The change from baseline in 24-hour urine renin levels with CIN-107 compared to placebo after 8 weeks of treatment (Part 1)
Trial Locations
- Locations (62)
CinCor Site 26
🇺🇸McAllen, Texas, United States
CinCor Site 70
🇺🇸Lynwood, California, United States
CinCor Site 46
🇺🇸Panorama City, California, United States
CinCor Site 16
🇺🇸Tampa, Florida, United States
CinCor Site 36
🇺🇸Northridge, California, United States
CinCor Site 29
🇺🇸Oceanside, California, United States
CinCor Site 41
🇺🇸Cooper City, Florida, United States
CinCor Site 52
🇺🇸West Hills, California, United States
CinCor Site 63
🇺🇸West Des Moines, Iowa, United States
CinCor Site 48
🇺🇸Austin, Texas, United States
CinCor Site 9
🇺🇸Jupiter, Florida, United States
CinCor Site 14
🇺🇸Buford, Georgia, United States
CinCor Site 59
🇺🇸Metairie, Louisiana, United States
CinCor Site 28
🇺🇸Homestead, Florida, United States
CinCor Site 1
🇺🇸Lake Worth, Florida, United States
CinCor Site 34
🇺🇸Winter Haven, Florida, United States
CinCor Site 42
🇺🇸Gurnee, Illinois, United States
CinCor Site 11
🇺🇸Brooklyn, New York, United States
CinCor Site 5
🇺🇸Norfolk, Virginia, United States
CinCor Site 20
🇺🇸Los Angeles, California, United States
CinCor Site 65
🇺🇸Staten Island, New York, United States
CinCor Site 47
🇺🇸San Dimas, California, United States
CinCor Site 49
🇺🇸Santa Ana, California, United States
CinCor Site 40
🇺🇸Chicago, Illinois, United States
CinCor Site 18
🇺🇸Clearwater, Florida, United States
CinCor Site 10
🇺🇸Sugar Land, Texas, United States
CinCor Site 15
🇺🇸Cincinnati, Ohio, United States
CinCor Site 12
🇺🇸Miami, Florida, United States
CinCor Site 54
🇺🇸Miami, Florida, United States
CinCor Site 55
🇺🇸Houston, Texas, United States
CinCor Site 27
🇺🇸Saraland, Alabama, United States
CinCor Site 35
🇺🇸Tucson, Arizona, United States
CinCor Site 69
🇺🇸Encinitas, California, United States
CinCor Site 6
🇺🇸Lincoln, California, United States
CinCor Site 43
🇺🇸Oklahoma City, Oklahoma, United States
CinCor Site 53
🇺🇸San Antonio, Texas, United States
CinCor Site 45
🇺🇸Salt Lake City, Utah, United States
CinCor Site 64
🇺🇸Olive Branch, Mississippi, United States
CinCor Site 25
🇺🇸Shreveport, Louisiana, United States
CinCor Site 19
🇺🇸New Orleans, Louisiana, United States
CinCor Site 31
🇺🇸Waterbury, Connecticut, United States
CinCor Site 30
🇺🇸Marrero, Louisiana, United States
CinCor Site 60
🇺🇸Chattanooga, Tennessee, United States
CinCor Site 57
🇺🇸Denver, Colorado, United States
CinCor Site 7
🇺🇸Lexington, Kentucky, United States
CinCor Site 4
🇺🇸Dayton, Ohio, United States
CinCor Site 21
🇺🇸Louisville, Kentucky, United States
CinCor Site 24
🇺🇸Columbus, Ohio, United States
CinCor Site 68
🇺🇸Dallas, Texas, United States
CinCor Site 22
🇺🇸Troy, Michigan, United States
CinCor Site 13
🇺🇸Miami, Florida, United States
CinCor Site 17
🇺🇸Miami, Florida, United States
CinCor Site 33
🇺🇸Addison, Illinois, United States
CinCor Site 2
🇺🇸Manassas, Virginia, United States
CinCor Site 32
🇺🇸Carrollton, Texas, United States
CinCor Site 58
🇺🇸Katy, Texas, United States
CinCor Site 3
🇺🇸Houston, Texas, United States
CinCor Site 62
🇺🇸Lampasas, Texas, United States
CinCor Site 61
🇺🇸Georgetown, Texas, United States
CinCor Site 50
🇺🇸Morton, Illinois, United States
CinCor Site 38
🇺🇸Elkridge, Maryland, United States
CinCor Site 72
🇺🇸Brownsburg, Indiana, United States