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Primary Prevention of Cardiovascular Disease (CVD) in Pre-diabetic & Pre-hypertensive Subjects

NCT01364675 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8900

Last updated 2011-06-02

No results posted yet for this study

Summary

The purpose of this study is to determine whether treating pre-diabetic \& pre-hypertensive individuals using multiple drugs intervention (anti-hypertensive drugs (i.e., ACEI) plus anti-glycemic drug (i.e., metformin) plus anti-hyperlipidemic drug (statin)) would lower Cardiovascular Disease (CVD) events.

Conditions

  • Pre-diabetes
  • Pre-hypertension

Interventions

DRUG

Metformin+Enalapril+Simvastatin

Poly-pill - composed of Metformin (500 mg), Enalapril (10 mg) and Simvastatin (10 mg) in single tablet given once daily after dinner for 4 years

DRUG

Placebo tablet

Identical Placebo Tablet

Sponsors & Collaborators

  • Ubon Ratchathani Public Health Office, Thailand

    collaborator OTHER_GOV

  • National Health Security Office, Thailand

    collaborator OTHER

  • The Government Pharmaceutical Organization

    collaborator OTHER_GOV

  • Ramathibodi Hospital

    lead OTHER

Principal Investigators

  • Phisitt Vejakama, M.D. · Section for clinical epidemiology and bioststistics, Faculty of medicine, Ramathibodi hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2016-07-31
Completion
2016-12-31

Countries

  • Thailand

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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 NCT01364675 on ClinicalTrials.gov