NCT05137002

A Study of CIN-107 in Patients With Uncontrolled Hypertension

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 249 (actual)
• Sponsor: CinCor Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Uncontrolled Hypertension

Interventions

Type	Name	Description
DRUG	CIN-107	CIN-107 tablets by mouth once daily
DRUG	Placebo	Placebo tablets by mouth once daily

Timeline

• Start date: 2021-12-07
• Primary completion: 2022-09-13
• Completion: 2022-10-10
• First posted: 2021-11-30
• Last updated: 2023-08-01
• Results posted: 2023-08-01

Locations

63 sites across 1 country: United States

Regulatory

• FDA-regulated drug study