CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 249 enrolled
Drug / intervention
CIN-107 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05137002
NCT05137002Phase 2Completed

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

CinCor Pharma, Inc.·interventional·Posted Nov 30, 2021·Updated Aug 1, 2023

In Brief

A Phase 2 clinical trial evaluating CIN-107 and Placebo for Uncontrolled Hypertension. Completed, enrolled 249 participants across 63 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedNov 30, 2021
Enrollment StartDec 7, 2021
Primary CompletionSep 13, 2022
Study CompletionOct 10, 2022
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 4.6 years ago

Interventions

CIN-107drug

CIN-107 tablets by mouth once daily

Placebodrug

Placebo tablets by mouth once daily