NCT02710552

Brief Summary

The aim of the study is to compare the efficacy and safety of low-dose combination of three antihypertensive drugs versus fixed high-dose combination of two antihypertensive drugs 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 17, 2016

Status Verified

March 1, 2016

Enrollment Period

2.9 years

First QC Date

March 4, 2016

Last Update Submit

March 16, 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)

Three antihypertensive Drugs

ACTIVE COMPARATOR

Patients will be treated with Tripliam, that is a commercially available fixed low-dose combination of three antihypertensive drugs, that is 5 mg/daily perindopril, 1,25 mg/daily indapamide and 5 mg/day amlodipine

Drug: Tripliam (perindopril, indapamide, amlodipine)

Two antihypertensive drugs

ACTIVE COMPARATOR

Patients will be treated with Reaptan, that is a commercially available fixed high-dose combination of two antihypertensive drugs, that is 10 mg/daily perindopril and 5 mg/day amlodipine

Drug: Reaptan (perindopril, amlodipine)

Interventions

Tripliam (perindopril, indapamide, amlodipine)DRUG

Fixed combination of perindopril 5 mg, indapamide 1,25 and amlodipine 5 mg

Also known as: Combination of three antihypertensive drugs
Three antihypertensive Drugs
Reaptan (perindopril, amlodipine)DRUG

Fixed combination of perindopril 10 mg and amlodipine 5 mg

Also known as: Combination of two antihypertensive drugs
Two antihypertensive drugs

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)

Sapienza University

Rome, 00161, Italy

Location

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

390649971md4151@mclink.it

Cesare Greco, MD

CONTACT

390649971md4151@mclink.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
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 17, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)