MedTrace Logo

Prevention of Cardiovascular Disease Using a Single PolyPill in an Urban Population - Focus on Liver-Related Variables.

NCT01245608 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2400

Last updated 2019-02-15

No results posted yet for this study

Summary

The primary purpose of this study is to determine the effects of a fixed dose combination of valsartan, hydrochlorothiazide, atorvastatin and aspirin (PolyPill) on prevention of cardiovascular events in adults older than 50.

Various liver-related variables will also be recorded which will allow studying the effects of PolyPill on the liver and the effect of liver diseases such as nonalcoholic steatohepatitis on cardiovascular events and the protective effect of PolyPill.

Conditions

Interventions

DRUG

Polypill

Polypill taken once daily for 5 years. Each pill contains acetylsalicylic acid 81 mg, atorvastatin 20 mg, hydrochlorothiazide 12.5 mg, valsartan 40 mg

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. · Tehran University of Medical Sciences

  • Shahin Merat, M.D. · Tehran University of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2018-01-31
Completion
2018-09-30

Countries

  • Iran

More Related Trials

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 NCT01245608 on ClinicalTrials.gov