Clinical trial NCT05432167
Conditions: Uncontrolled Hypertension Chronic Kidney Diseases
Sponsor: AstraZeneca
Start date: 2022-04-29; Completion date: 2024-05-02
Enrollment: 195 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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).

Detailed description:
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.

Arms: arm 1: Patients will take oral tablets of CIN-107 for 26 weeks. The dose strength may be titrated within 6 weeks. arm 2: Patients will take oral tablets of CIN-107 for 26 weeks. The dose strength may be titrated within 6 weeks. arm 3: Patients will take oral tablets of Placebo for 26 weeks. The dose strength may be titrated within 6 weeks.
Interventions: intervention 1: CIN-107 intervention 2: Placebo
Intervention descriptions: intervention 1: Patients will take CIN-107 tablets by mouth once daily. intervention 2: Patients will take placebo tablets by mouth once daily.

Protocol documents:
Prot_002.pdf: 


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