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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
249
CIN-107 tablets by mouth once daily
Placebo tablets by mouth once daily
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 20
Los Angeles, California, United States
CinCor Site 70
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).
Time frame: 8 weeks
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)
Time frame: 8 weeks
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)
Time frame: 8 weeks
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)
Time frame: 8 weeks
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)
Time frame: 8 weeks
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)
Time frame: 8 weeks
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)
Time frame: 8 weeks
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Lynwood, California, United States
CinCor Site 36
Northridge, California, United States
CinCor Site 29
Oceanside, California, United States
CinCor Site 46
Panorama City, California, United States
CinCor Site 47
San Dimas, California, United States
...and 53 more locations