CClinicalTrials.gg
Status unknownNCT027105523DUpdated Mar 17, 2016

Low-dose Combination of Three Antihypertensive Drugs

A Phase 4 interventional study of Tripliam (perindopril, indapamide, amlodipine) and Reaptan (perindopril, amlodipine) in Arterial Hypertension, sponsored by University of Roma La Sapienza. Status unknown at 1 site in Italy. Per ClinicalTrials.gov, last updated 2016-03-17.

Sponsored by University of Roma La Sapienza · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Sex
All
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Study 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

Read the detailed description

The aim of the study is to compare the efficacy and safety of commercially available low-dose combination of three antihypertensive drugs versus commercially available fixed high-dose combination of two antihypertensive drugs in arterial hypertension

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Conditions studied

  • Arterial Hypertension

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Keywords

  • arterial hypertension
  • antihypertensive drugs
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In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's planned enrollment of 100 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

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Lead sponsor

University of Roma La Sapienza is the lead sponsor of 388 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Patients with arterial hypertension resistant to monotherapy

Exclusion criteria

Exclusion Criteria:

None

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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Three antihypertensive Drugs

    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)

  • Active comparator
    Two antihypertensive drugs

    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

  • DrugTripliam (perindopril, indapamide, amlodipine)

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

    Also known as: Combination of three antihypertensive drugs

  • DrugReaptan (perindopril, amlodipine)

    Fixed combination of perindopril 10 mg and amlodipine 5 mg

    Also known as: Combination of two antihypertensive drugs

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What researchers measure

Primary outcomes

  1. Number of patients who reach target blood pressure

    How many patients have blood pressure within normal limits

    Time frame: From baseline to the end of the 3-month study period

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Study locations

1 site
  • Sapienza University
    Rome, 00161, Italy
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02710552
Lead sponsor
University of Roma La Sapienza
Responsible party
Francesco Pelliccia (Assistant Professor, University of Roma La Sapienza) — Principal investigator
First posted
Mar 16, 2016
Start date
Apr 2016
Primary completion
Mar 2019 (estimated)
Completion
Mar 2020 (estimated)
Last update
Mar 17, 2016

Study contacts

Francesco Pelliccia, MD
Contact
md4151@mclink.it
390649971 ext. 123
Cesare Greco, MD
Contact
md4151@mclink.it
390649971 ext. 123
Carlo Gaudio, MD
study chair · Sapienza University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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