NCT04162366

A Research Study to Show Aprocitentan is Efficacious and Safe to Treat Patients With Uncontrolled Blood Pressure and Chronic Kidney Disease.

Multi-center, Blinded, Randomized Study With Aprocitentan in Subjects With Uncontrolled Blood Pressure and Chronic Kidney Disease Stage 3 or 4.

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to show the blood pressure lowering effect of aprocitentan, a new drug, when added to the background antihypertensive therapy in patients with uncontrolled blood pressure and chronic kidney disease (CKD) stage 3 or 4. Participation in the research study will last up to 21 weeks (about 5 months).

Conditions

• Hypertension
• Renal Insufficiency, Chronic

Interventions

Type	Name	Description
DRUG	Aprocitentan 25 mg	Tablet, oral use once daily
DRUG	Placebo	Matching placebo tablet, oral use once daily

Timeline

• Start date: 2020-01-01
• Primary completion: 2021-06-30
• Completion: 2021-07-15
• First posted: 2019-11-14
• Last updated: 2022-11-23

Regulatory

• FDA-regulated drug study