NCT05820880

Efficacy and Safety of Perindopril 5 mg / Indapamide 1.25 mg / Amlodipine 5 mg Fixed Combination in Hypertension

Evaluation of the Clinical Efficacy and Safety of Perindopril 5 mg / Indapamide 1.25 mg / Amlodipine 5 mg Fixed Combination in Single-pill After 2 Months of Treatment Versus Free Combination, Perindopril 4 mg / Indapamide 1.25 mg + Amlodipine 5 mg Given Separately at the Same Time, With Conditional Titration Based on Blood Pressure Control in Patients With Essential Hypertension Uncontrolled After 1 Month With Perindopril 4 mg / Indapamide 1.25 mg Bi-therapy.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 532 (actual)
• Sponsor: Institut de Recherches Internationales Servier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the efficacy and safety of a fixed-dose combination of perindopril 5 mg /indapamide 1.25 mg / amlodipine 5 mg compared to the free combination of the same components (perindopril 4 mg / indapamide 1.25 mg in a single pill and amlodipine 5 mg pill given separately at the same time) in chinese patients with uncontrolled essential hypertension.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Fixed [Per/Ind/Aml]	Fixed Dose combination of Perindopril/Indapamide/Amlodipine
DRUG	Free [Per/Ind + Aml]	Free dose combination of Perindopril/Indapamide and Amlodipine

Timeline

• Start date: 2019-05-06
• Primary completion: 2022-02-23
• Completion: 2022-02-23
• First posted: 2023-04-20
• Last updated: 2024-07-25

Locations

42 sites across 1 country: China