Trial | NCT01364675  Report issue

Title

Primary Prevention of Cardiovascular Disease (CVD) in Pre-diabetic & Pre-hypertensive Subjects
Primary Prevention of Cardiovascular Disease in Pre-diabetic & Pre-hypertensive Subjects Using Multiple Risks Reduction Strategy: A Multi-center, Double-blind, Randomized Controlled Trial

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    8900
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.
The risks of CVD are not confined to a subset of established "hypertensive" or "diabetic" population, but also increase among those with suboptimal blood pressure and glycemic level, namely "pre-hypertensive" or "pre-diabetic" population. Evidence on the effectiveness of drug interventions to lower CVD events in pre-clinical stage population has been scant.
Study Started
Jan 31
2012
Primary Completion
Jul 31
2016
Anticipated
Study Completion
Dec 31
2016
Anticipated
Last Update
Jun 02
2011
Estimate

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

  • Other names: Poly-pill

Drug Placebo tablet

Identical Placebo Tablet

  • Other names: Placebo

Metformin+Enalapril+Simvastatin Experimental

Placebo tablet Placebo Comparator

Criteria 

Inclusion Criteria:

Pre-diabetes
Pre-hypertensives
LDL-Cholesterol >= 100 < 190 mg/dl
BMI >= 23
Estimated GFR >= 60 ml/min/1.73 m2 (MDRD equation)
Willing to participate and provide written inform consent

Exclusion Criteria:

Current involved in other studied medications
Regular use of corticosteroids
Current use of weight loss medication
History of renal disease
Active liver disease including jaundice, chronic hepatitis with ALT >= 2.5 the upper normal limit
Active malignancy
Major psychiatric disorder
Diseases and medications that affect glucose tolerance (e.g. pheochromocytoma, Cushing's syndrome, acromegaly, steroid-dependent asthma, protease inhibitors, antipsychotics)
Nursing women, pregnant women, or those that plan to become pregnant in the study period
No Results Posted