Low-dose Combination of Three Antihypertensive Drugs (3D)

March 16, 2016 updated by: Francesco Pelliccia, University of Roma La Sapienza

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)

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Francesco Pelliccia, MD
  • Phone Number: 123 390649971
  • Email: md4151@mclink.it

Study Contact Backup

Study Locations

  • Italy
      • Rome, Italy, 00161
        • Sapienza University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients with arterial hypertension resistant to monotherapy

Exclusion Criteria:

None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Three antihypertensive Drugs
Patients will be treated with Tripliam, that is a commercially available fixed low-dose combination of three antihypertensive drugs, that is 5 mg/daily perindopril, 1,25 mg/daily indapamide and 5 mg/day amlodipine
Drug: Tripliam (perindopril, indapamide, amlodipine)
Fixed combination of perindopril 5 mg, indapamide 1,25 and amlodipine 5 mg
Other Names:
  • Combination of three antihypertensive drugs
Active Comparator: Two antihypertensive drugs
Patients will be treated with Reaptan, that is a commercially available fixed high-dose combination of two antihypertensive drugs, that is 10 mg/daily perindopril and 5 mg/day amlodipine
Drug: Reaptan (perindopril, amlodipine)
Fixed combination of perindopril 10 mg and amlodipine 5 mg
Other Names:
  • Combination of two antihypertensive drugs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients who reach target blood pressure
Time Frame: From baseline to the end of the 3-month study period
How many patients have blood pressure within normal limits
From baseline to the end of the 3-month study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

March 4, 2016

First Submitted That Met QC Criteria

March 15, 2016

First Posted (Estimate)

March 16, 2016

Study Record Updates

Last Update Posted (Estimate)

March 17, 2016

Last Update Submitted That Met QC Criteria

March 16, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 123/D/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Dietary Supplements

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Locations

3
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