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

Primary Purpose

Arterial Hypertension

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
perindopril, indapamide , amlodipine
Tripliam (perindopril, indapamide, amlodipine)
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arterial Hypertension focused on measuring arterial hypertension, antihypertensive drugs

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with arterial hypertension resistant to monotherapy

Exclusion Criteria:

None

Sites / Locations

  • University La Sapienza

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Free combination

Tripliam

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of patients who reach target blood pressure
How many patients have blood pressure within normal limits

Secondary Outcome Measures

Full Information

First Posted
March 4, 2016
Last Updated
March 15, 2016
Sponsor
University of Roma La Sapienza
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1. Study Identification

Unique Protocol Identification Number
NCT02710539
Brief Title
Once-daily Fixed Combination of Three Antihypertensive Drugs
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
March 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Hypertension
Keywords
arterial hypertension, antihypertensive drugs

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Free combination
Arm Type
Active Comparator
Arm Description
Perindopril 10 mg/daily, indapamide 2,5 mg/daily, and amlodipine 10 mg/daily will be given according to a free combination strategy
Arm Title
Tripliam
Arm Type
Active Comparator
Arm Description
fixed combination of perindopril 10 mg/daily, indapamide 2,5 mg/daily, amlodipine 10 mg/daily
Intervention Type
Drug
Intervention Name(s)
perindopril, indapamide , amlodipine
Other Intervention Name(s)
Procaptan, Indapamide, Norvasc
Intervention Description
Free combination of perindopril 10 mg, indapamide 2,5 mg, amlodipine 10 mg
Intervention Type
Drug
Intervention Name(s)
Tripliam (perindopril, indapamide, amlodipine)
Other Intervention Name(s)
Fixed combination of Procaptan, Indapamide, Norvasc
Intervention Description
Fixed combination of perindopril 10 mg, indapamide 2,5 mg, amlodipine 10 mg
Primary Outcome Measure Information:
Title
Number of patients who reach target blood pressure
Description
How many patients have blood pressure within normal limits
Time Frame
From baseline to the end of the 3-month study period

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with arterial hypertension resistant to monotherapy Exclusion Criteria: None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francesco Pelliccia, MD
Phone
+39064997
Ext
123
Email
f.pelliccia@mclink.it
First Name & Middle Initial & Last Name or Official Title & Degree
Cesare Greco, MD
Phone
+39064997
Ext
123
Email
md4151@mclink.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlo Gaudio, MD
Organizational Affiliation
Sapienza University
Official's Role
Study Chair
Facility Information:
Facility Name
University La Sapienza
City
Rome
ZIP/Postal Code
00166
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27522394
Citation
Marazzi G, Pelliccia F, Campolongo G, Cacciotti L, Massaro R, Poggi S, Tanzilli A, Di Iorio M, Volterrani M, Lainscak M, Rosano GM. Greater cardiovascular risk reduction with once-daily fixed combination of three antihypertensive agents and statin versus free-drug combination: The ALL-IN-ONE trial. Int J Cardiol. 2016 Nov 1;222:885-887. doi: 10.1016/j.ijcard.2016.07.163. Epub 2016 Jul 29.
Results Reference
derived

Learn more about this trial

Once-daily Fixed Combination of Three Antihypertensive Drugs

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