This study will evaluate the efficacy and safety of CIN-107 for the treatment of hypertension in patients with uncontrolled hypertension (uHTN) and Chronic Kidney Disease (CKD).
This randomized, double-blind, placebo-controlled will evaluate the efficacy and safety of CIN-107 in patients with uHTN and CKD. Approximately 200 patients will be randomized in a 1:1:1 ratio into 1 of the 3 treatment groups (placebo, low dose treatment strategy and high dose treatment strategy). The study will consist of the following 3 periods: * A Screening Period of up to 5 weeks; * A Double-Blind Treatment Period of 26 weeks; and * A Follow-Up Period of 2 weeks. Patients will complete the study in approximately 8 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
195
Change From Baseline in Mean Seated Systolic Blood Pressure (SBP) of Pooled CIN-107 and Placebo
Mean change in seated SBP from baseline to Week 26 of pooled CIN-107 and placebo was assessed.
Time frame: At Week 26
Change From Baseline in SBP in CIN-107 Compared to Placebo in Participants Assigned to the High-dose Strategy Group
Mean change in seated SBP from baseline to Week 26 of high-dose CIN-107 dosing group and placebo was assessed.
Time frame: At Week 26
Change From Baseline of SBP in CIN-107 Compared to Placebo in Participants Assigned to the Low-dose Strategy Group
The mean change in seated SBP from baseline to Week 26 of low-dose CIN-107 dosing group and placebo was assessed.
Time frame: At Week 26
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Research Site
Birmingham, Alabama, United States
Research Site
Huntsville, Alabama, United States
Research Site
Beverly Hills, California, United States
Research Site
Chula Vista, California, United States
Research Site
Fountain Valley, California, United States
Research Site
Granada Hills, California, United States
Research Site
Lancaster, California, United States
Research Site
Lincoln, California, United States
Research Site
Los Angeles, California, United States
Research Site
Lynwood, California, United States
...and 61 more locations