Randomized Comparison of Once-daily Fixed combiNation vErsus freE-drug cOmbination of Three aNtihypertensive Agents in arteriaL hYpertension (the ONE&ONLY Trial)
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Number of patients who reach target blood pressure
Study Overview
Brief Summary
Randomized comparison of once-daily fixed combiNation versus free-drug combination of three antihypertensive agents in arterial hypertension
Detailed 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with arterial hypertension resistant to monotherapy
Exclusion Criteria
- Not provided
Arms & Interventions
Free combination
Perindopril 10 mg/daily, indapamide 2,5 mg/daily, and amlodipine 10 mg/daily will be given according to a free combination strategy
Intervention: perindopril, indapamide , amlodipine (Drug)
Tripliam
fixed combination of perindopril 10 mg/daily, indapamide 2,5 mg/daily, amlodipine 10 mg/daily
Intervention: Tripliam (perindopril, indapamide, amlodipine) (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Francesco Pelliccia
Assistant Professor
University of Roma La Sapienza