Once-daily Fixed Combination of Three Antihypertensive Drugs

Phase 4

• Conditions: Arterial Hypertension
• Interventions: Drug: Tripliam (perindopril, indapamide, amlodipine); Drug: perindopril, indapamide , amlodipine

• Registration Number: NCT02710539
• Lead Sponsor: University of Roma La Sapienza

Brief Summary

Randomized comparison of once-daily fixed combiNation versus free-drug combination of three antihypertensive agents in arterial hypertension

Detailed Description

The aim of this randomized study is to compare a once-daily fixed combination pill with a free-drug combination of three antihypertensive agents in arterial hypertension

Study Timeline

• Status Verified: 2016-03
• Study First Submitted: 2016-03-04
• Study First Submitted QC: 2016-03-15
• Last Update Submitted: 2016-03-15
• Study First Posted: 2016-03-16
• Last Update Posted: 2016-03-16
• Study Start: 2016-04
• Primary Completion: 2019-03
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Patients with arterial hypertension resistant to monotherapy

Exclusion Criteria

None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tripliam	Tripliam (perindopril, indapamide, amlodipine)	fixed combination of perindopril 10 mg/daily, indapamide 2,5 mg/daily, amlodipine 10 mg/daily
Free combination	perindopril, indapamide , amlodipine	Perindopril 10 mg/daily, indapamide 2,5 mg/daily, and amlodipine 10 mg/daily will be given according to a free combination strategy

Primary Outcome Measures

Name	Time	Method
Number of patients who reach target blood pressure	From baseline to the end of the 3-month study period	How many patients have blood pressure within normal limits

Trial Locations

Locations (1)

University La Sapienza; 🇮🇹 Rome, Italy