Once-daily Fixed Combination of Three Antihypertensive Drugs (ONE&ONLY)

University of Roma La Sapienza

Status and phase: Unknown; Phase 4

Conditions: Arterial Hypertension

Treatments: Drug: Tripliam (perindopril, indapamide, amlodipine); Drug: perindopril, indapamide , amlodipine

Study type: Interventional

Funder types: Other

Identifiers

NCT02710539

124/D/2016

Details and patient eligibility

About

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

Full 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

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients with arterial hypertension resistant to monotherapy

Exclusion criteria

None

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Free combination

Active Comparator group

Description:

Perindopril 10 mg/daily, indapamide 2,5 mg/daily, and amlodipine 10 mg/daily will be given according to a free combination strategy

Treatment:

Drug: perindopril, indapamide , amlodipine

Tripliam

Active Comparator group

Description:

fixed combination of perindopril 10 mg/daily, indapamide 2,5 mg/daily, amlodipine 10 mg/daily

Treatment:

Drug: Tripliam (perindopril, indapamide, amlodipine)