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

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ClinicalTrials.gov Identifier: NCT02710539
Recruitment Status : Unknown
Verified March 2016 by Francesco Pelliccia, University of Roma La Sapienza.
Recruitment status was:  Not yet recruiting
First Posted : March 16, 2016
Last Update Posted : March 16, 2016
Sponsor:
Information provided by (Responsible Party):
Francesco Pelliccia, University of Roma La Sapienza

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

Condition or disease Intervention/treatment Phase
Arterial Hypertension Drug: perindopril, indapamide , amlodipine Drug: Tripliam (perindopril, indapamide, amlodipine) Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Comparison of Once-daily Fixed combiNation vErsus freE-drug cOmbination of Three aNtihypertensive Agents in arteriaL hYpertension (the ONE&ONLY Trial)
Study Start Date : April 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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
Drug: perindopril, indapamide , amlodipine
Free combination of perindopril 10 mg, indapamide 2,5 mg, amlodipine 10 mg
Other Name: Procaptan, Indapamide, Norvasc

Active Comparator: Tripliam
fixed combination of perindopril 10 mg/daily, indapamide 2,5 mg/daily, amlodipine 10 mg/daily
Drug: Tripliam (perindopril, indapamide, amlodipine)
Fixed combination of perindopril 10 mg, indapamide 2,5 mg, amlodipine 10 mg
Other Name: Fixed combination of Procaptan, Indapamide, Norvasc




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients with arterial hypertension resistant to monotherapy

Exclusion Criteria:

None


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02710539


Contacts
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Contact: Francesco Pelliccia, MD +39064997 ext 123 f.pelliccia@mclink.it
Contact: Cesare Greco, MD +39064997 ext 123 md4151@mclink.it

Locations
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Italy
University La Sapienza
Rome, Italy, 00166
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
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Study Chair: Carlo Gaudio, MD Sapienza University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Francesco Pelliccia, Assistant Professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT02710539    
Other Study ID Numbers: 124/D/2016
First Posted: March 16, 2016    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Francesco Pelliccia, University of Roma La Sapienza:
arterial hypertension
antihypertensive drugs
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Perindopril
Indapamide
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Diuretics
Natriuretic Agents
Sodium Chloride Symporter Inhibitors