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Prevention of Cardiovascular Disease in Middle-aged and Elderly Iranians Using a Single PolyPill

NCT01271985 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 8410

Last updated 2019-01-22

No results posted yet for this study

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.

Conditions

Interventions

DRUG

PolyPill

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

OTHER

Minimal care

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

Sponsors & Collaborators

  • Golestan University of Medical sciences

    collaborator OTHER

  • University of Birmingham

    collaborator OTHER

  • Tehran University of Medical Sciences

    lead OTHER

Principal Investigators

  • Reza Malekzadeh, M.D. · Digestive Disease Research Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2019-01-31
Completion
2019-01-31

Countries

  • Iran

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01271985 on ClinicalTrials.gov