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Polypill For Prevention of Cardiovascular Disease

NCT00567307 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2018-09-10

Study results available
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Summary

The purpose of this pilot study is to provide data on the feasibility of conducting a large clinical trial on the polypill (combination of aspirin, angiotensin converting enzyme inhibitor, thiazide diuretic, and statin) for primary prevention of cardiovascular disease (CVD). We hypothesized that A "polypill" comprising the aforementioned four components would significantly reduce the estimated 10-year total CVD risk score with high adherence and no significant increase in adverse effects compared to the standard practice.

Conditions

Interventions

DRUG

Red Heart Pill 2b (Polypill)

Arm A will receive the polypill (Red Heart pill 2b) which is a combination of aspirin (75 mg), simvastatin (20g), lisinopril (10mg) and hydrochlorothiazide (12.5 mg)

OTHER

Standard Practice

Arm B will receive management of their CVD risk according to the usual care given to participants in similar conditions

Sponsors & Collaborators

  • World Health Organization

    collaborator OTHER

  • National Hospital of Sri Lanka

    collaborator OTHER_GOV

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Elsayed Z Soliman, MD, MSc, MS · Wake Forest University Health Sciences

  • Shanthi Mendis, MD, FRCP · World Heath Organization

  • Curt D Furberg, MD, PhD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-12-31
Completion
2010-01-31
FDA Drug
Yes

Countries

  • Sri Lanka

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00567307 on ClinicalTrials.gov