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NCT02710539 Clinical Trial

Once-daily Fixed Combination of Three Antihypertensive Drugs

Arterial Hypertension Clinical Trial

— ONE&ONLY  

Official title:
Randomized Comparison of Once-daily Fixed combiNation vErsus freE-drug cOmbination of Three aNtihypertensive Agents in arteriaL hYpertension (the ONE&ONLY Trial)

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02710539
Other study ID # 124/D/2016
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received March 4, 2016
Last updated March 15, 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 +39064997
Email f.pelliccia@mclink.it
Is FDA regulated No
Health authority Italy: National Institute of Health
Study type Interventional

Clinical Trial Summary

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

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

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: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• perindopril, indapamide , amlodipine
Free combination of perindopril 10 mg, indapamide 2,5 mg, amlodipine 10 mg
• Tripliam (perindopril, indapamide, amlodipine)
Fixed combination of perindopril 10 mg, indapamide 2,5 mg, amlodipine 10 mg

Locations
Country Name City State
Italy University La Sapienza 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 Yes
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