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

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ClinicalTrials.gov Identifier: NCT01364675
Recruitment Status : Unknown
Verified May 2011 by Ramathibodi Hospital.
Recruitment status was:  Not yet recruiting
First Posted : June 2, 2011
Last Update Posted : June 2, 2011
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment
Pre-diabetes Pre-hypertension Drug: Metformin+Enalapril+Simvastatin Drug: Placebo tablet

Detailed Description:
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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Primary Prevention of Cardiovascular Disease in Pre-diabetic & Pre-hypertensive Subjects Using Multiple Risks Reduction Strategy: A Multi-center, Double-blind, Randomized Controlled Trial
Study Start Date : January 2012
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Metformin+Enalapril+Simvastatin 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 Name: Poly-pill
Placebo Comparator: Placebo tablet Drug: Placebo tablet
Identical Placebo Tablet
Other Name: Placebo

Outcome Measures

Primary Outcome Measures :
  1. Cardiovascular Events [ Time Frame: 4-year ]
    Fatal or Non-fatal Myocardial Infarction, Angina Pectoris, Congestive Heart Failure, Coronary Revascularization, Fatal or Non-fatal Stroke, Amputation of Lower Extremities (non-traumatic cause)

Secondary Outcome Measures :
  1. Micro-vascular Complications [ Time Frame: 4-year ]
    Renal dysfunction, ESRD (on dialysis or kidney transplantation), Progression of Albuminuria, Retinopathy

  2. Cumulative Incidence of Diabetes [ Time Frame: 4-year ]
  3. Cumulative Incidence of Hypertension [ Time Frame: 4-year ]
  4. Incidence of Individual Cardiovascular Disease [ Time Frame: 4-year ]

    Coronary Artery Disease - Myocardial Infarction, Angina Pectoris, Congestive Heart Failure, Coronary Revascularization

    Stroke- Cerebral Hemorrhage, Cerebral Infarction, Subarachnoid Hemorrhage

    Peripheral Artery Disease- Leg amputation, endovascular or surgical intervention in leg arteries

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01364675

Contact: Phisitt Vejakama, M.D. 66849562882 toughcountrydoc@gmail.com
Contact: Ammarin Thakkinstian, Ph.D. 66818436266 raatk@mahidol.ac.th

Ubon ratchathani Public Health Office Not yet recruiting
Muang District, Ubon ratchathani, Thailand, 34000
Principal Investigator: Phisitt Vejakama, M.D.         
Sponsors and Collaborators
Ramathibodi Hospital
Ubon Ratchathani Public Health Office, Thailand
National Health Security Office, Thailand
The Government Pharmaceutical Organization
Principal Investigator: Phisitt Vejakama, M.D. Section for clinical epidemiology and bioststistics, Faculty of medicine, Ramathibodi hospital
More Information

Responsible Party: Phisitt Vejakama, Section for clinical epidemiology, Faculty of medicine, Ramathibodi hospital, Thailand
ClinicalTrials.gov Identifier: NCT01364675     History of Changes
Other Study ID Numbers: 12011
First Posted: June 2, 2011    Key Record Dates
Last Update Posted: June 2, 2011
Last Verified: May 2011

Keywords provided by Ramathibodi Hospital:
Impaired fasting glucose
Impaired glucose tolerance
Cardiovascular events

Additional relevant MeSH terms:
Cardiovascular Diseases
Prediabetic State
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Antihypertensive Agents