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NCT02710552 Clinical Trial

Low-dose Combination of Three Antihypertensive Drugs

Arterial Hypertension Clinical Trial

— 3D  

Official title:
Randomized Comparison of Fixed Low-dose Combination of THREE Antihypertensive Drugs Versus Fixed High-dose Combination of Two Antihypertensive Drugs in Arterial Hypertension (the 3D Trial)

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02710552
Other study ID # 123/D/2016
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received March 4, 2016
Last updated March 16, 2016
Start date April 2016
Est. completion date March 2020

Study information
Verified date March 2016
Source University of Roma La Sapienza
Contact Francesco Pelliccia, MD
Phone 390649971
Email md4151@mclink.it
Is FDA regulated No
Health authority Italy: Ministry of Health
Study type Interventional

Clinical Trial Summary

The aim of the study is to compare the efficacy and safety of low-dose combination of three antihypertensive drugs versus fixed high-dose combination of two antihypertensive drugs in arterial hypertension

Description:

The aim of the study is to compare the efficacy and safety of commercially available low-dose combination of three antihypertensive drugs versus commercially available fixed high-dose combination of two antihypertensive drugs in arterial hypertension

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date March 2020
Est. primary completion date March 2019
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

Patients with arterial hypertension resistant to monotherapy

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Tripliam (perindopril, indapamide, amlodipine)
Fixed combination of perindopril 5 mg, indapamide 1,25 and amlodipine 5 mg
• Reaptan (perindopril, amlodipine)
Fixed combination of perindopril 10 mg and amlodipine 5 mg

Locations
Country Name City State
Italy Sapienza University Rome

Sponsors (1)
Lead Sponsor Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients who reach target blood pressure How many patients have blood pressure within normal limits From baseline to the end of the 3-month study period No
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