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Once-daily Fixed Combination of Three Antihypertensive Drugs

Randomized Comparison of Once-daily Fixed combiNation vErsus freE-drug cOmbination of Three aNtihypertensive Agents in arteriaL hYpertension (the ONE&ONLY Trial)

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02710539
Acronym
ONE&ONLY
Enrollment
100
Registered
2016-03-16
Start date
2016-04-30
Completion date
2020-03-31
Last updated
2016-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterial Hypertension

Keywords

arterial hypertension, antihypertensive drugs

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

Interventions

DRUGperindopril, indapamide , amlodipine

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

DRUGTripliam (perindopril, indapamide, amlodipine)

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

Sponsors

University of Roma La Sapienza
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

Patients with arterial hypertension resistant to monotherapy

Exclusion criteria

None

Design outcomes

Primary

MeasureTime frameDescription
Number of patients who reach target blood pressureFrom baseline to the end of the 3-month study periodHow many patients have blood pressure within normal limits

Countries

Italy

Contacts

Primary ContactFrancesco Pelliccia, MD
f.pelliccia@mclink.it+39064997
Backup ContactCesare Greco, MD
md4151@mclink.it+39064997

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026