Low-dose Combination of Three Antihypertensive Drugs

NCT ID: NCT02710552

Last Updated: 2016-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2020-03-31

Brief Summary

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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

Detailed Description

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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

Conditions

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Arterial Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Tripliam (perindopril, indapamide, amlodipine)

Intervention Type DRUG

Fixed combination of perindopril 5 mg, indapamide 1,25 and amlodipine 5 mg

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

Group Type ACTIVE_COMPARATOR

Reaptan (perindopril, amlodipine)

Intervention Type DRUG

Fixed combination of perindopril 10 mg and amlodipine 5 mg

Interventions

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Tripliam (perindopril, indapamide, amlodipine)

Fixed combination of perindopril 5 mg, indapamide 1,25 and amlodipine 5 mg

Intervention Type DRUG

Reaptan (perindopril, amlodipine)

Fixed combination of perindopril 10 mg and amlodipine 5 mg

Intervention Type DRUG

Other Intervention Names

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Combination of three antihypertensive drugs Combination of two antihypertensive drugs

Eligibility Criteria

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Inclusion Criteria

Patients with arterial hypertension resistant to monotherapy

Exclusion Criteria

None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Roma La Sapienza

OTHER

Sponsor Role lead

Responsible Party

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Francesco Pelliccia

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carlo Gaudio, MD

Role: STUDY_CHAIR

Sapienza University

Locations

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Sapienza University

Rome, , Italy

Site Status

Countries

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Italy

Central Contacts

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Francesco Pelliccia, MD

Role: CONTACT

390649971 ext. 123

Cesare Greco, MD

Role: CONTACT

390649971 ext. 123

Other Identifiers

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123/D/2016

Identifier Type: -

Identifier Source: org_study_id

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