CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 8,410 enrolled
Drug / intervention
PolyPill +1 moredrug
Likely dose
PolyPill 81 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01271985
NCT01271985Phase 3Completed
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Fixed-dose Combination Therapy (PolyPill) in Primary and Secondary Prevention of Cardiovascular Disease in Middle-aged and Elderly Iranians

Tehran University of Medical Sciences·interventional·Posted Jan 7, 2011·Updated Jan 22, 2019

In Brief

A Phase 3 clinical trial evaluating PolyPill and Minimal care for Cardiovascular Diseases. Completed, enrolled 8,410 participants across 1 site.

Detailed Summary

The purpose of this study is to determine the effects of PolyPill tablet (a fixed dose combination of two anti-hypertensive medications, atorvastatin and aspirin) on primary and secondary prevention of cardiovascular disease in Iranian adults older than 50.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiovascular Diseases
CountriesIran
CollaboratorsGolestan University of Medical sciences, University of Birmingham

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 7, 2011
Enrollment StartFeb 1, 2011
Primary CompletionJan 1, 2019
TodayJul 2, 2026
Enrollment to primary: 7.9 yearsPosted 15.5 years ago

Interventions

PolyPilldrug

A combination tablet containing Aspirin 81 mg, enalapril 5 mg (or valsartan 40 mg), atorvastatin 20 mg and hydrochlorothiazide 12.5 mg taken once daily

Minimal careother

Health education pamphlet on reducing cardiovascular risk factors, direct education on reducing cardiovascular risk factors provided by the study physician and the Community Health Worker, biannual follow-up and BP measurement