Once-daily Fixed Combination of Three Antihypertensive Drugs

NCT ID: NCT02710539

Last Updated: 2016-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2020-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Arterial Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type ACTIVE_COMPARATOR

perindopril, indapamide , amlodipine

Intervention Type DRUG

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

Tripliam

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

Group Type ACTIVE_COMPARATOR

Tripliam (perindopril, indapamide, amlodipine)

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

perindopril, indapamide , amlodipine

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

Intervention Type DRUG

Tripliam (perindopril, indapamide, amlodipine)

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Procaptan, Indapamide, Norvasc Fixed combination of Procaptan, Indapamide, Norvasc

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Patients with arterial hypertension resistant to monotherapy

Exclusion Criteria

None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Roma La Sapienza

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Francesco Pelliccia

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Carlo Gaudio, MD

Role: STUDY_CHAIR

Sapienza University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University La Sapienza

Rome, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Francesco Pelliccia, MD

Role: CONTACT

+39064997 ext. 123

Cesare Greco, MD

Role: CONTACT

+39064997 ext. 123

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 27522394 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

124/D/2016

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Fixed-Free HTN Trial
NCT03578042 UNKNOWN PHASE4
Essential Hypertension
NCT01264692 COMPLETED PHASE2