NCT02710539

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2016

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 16, 2016

Completed
16 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

March 16, 2016

Status Verified

March 1, 2016

Enrollment Period

2.9 years

First QC Date

March 4, 2016

Last Update Submit

March 15, 2016

Conditions

Arterial Hypertension

Keywords

arterial hypertensionantihypertensive drugs

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Free combination

ACTIVE COMPARATOR

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

Tripliam

ACTIVE COMPARATOR

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

Drug: Tripliam (perindopril, indapamide, amlodipine)

Interventions

perindopril, indapamide , amlodipineDRUG

Free combination of perindopril 10 mg, indapamide 2,5 mg, amlodipine 10 mg

Also known as: Procaptan, Indapamide, Norvasc
Free combination
Tripliam (perindopril, indapamide, amlodipine)DRUG

Fixed combination of perindopril 10 mg, indapamide 2,5 mg, amlodipine 10 mg

Also known as: Fixed combination of Procaptan, Indapamide, Norvasc
Tripliam

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with arterial hypertension resistant to monotherapy

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University La Sapienza

Rome, 00166, Italy

Location

Related Publications (1)

  • 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.

    PMID: 27522394DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

PerindoprilIndapamideAmlodipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsSulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsDihydropyridinesPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Carlo Gaudio, MD

    Sapienza University

    STUDY CHAIR

Central Study Contacts

Francesco Pelliccia, MD

CONTACT

+39064997f.pelliccia@mclink.it

Cesare Greco, MD

CONTACT

+39064997md4151@mclink.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 4, 2016

First Posted

March 16, 2016

Study Start

April 1, 2016

Primary Completion

March 1, 2019

Study Completion

March 1, 2020

Last Updated

March 16, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)