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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pre-diabetes Pre-hypertension | Drug: Metformin+Enalapril+Simvastatin Drug: Placebo tablet | Not Applicable |
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 |

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
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- 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)
- Micro-vascular Complications [ Time Frame: 4-year ]Renal dysfunction, ESRD (on dialysis or kidney transplantation), Progression of Albuminuria, Retinopathy
- Cumulative Incidence of Diabetes [ Time Frame: 4-year ]
- Cumulative Incidence of Hypertension [ Time Frame: 4-year ]
- 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

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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

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 |
Thailand | |
Ubon ratchathani Public Health Office | Not yet recruiting |
Muang District, Ubon ratchathani, Thailand, 34000 | |
Principal Investigator: Phisitt Vejakama, M.D. |
Principal Investigator: | Phisitt Vejakama, M.D. | Section for clinical epidemiology and bioststistics, Faculty of medicine, Ramathibodi hospital |
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 Pre-diabetes Pre-hypertensives Cardiovascular events |
Additional relevant MeSH terms:
Cardiovascular Diseases Prediabetic State Glucose Intolerance Prehypertension Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Hyperglycemia Vascular Diseases Metformin Simvastatin Enalapril |
Enalaprilat Hypoglycemic Agents Physiological Effects of Drugs Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Antihypertensive Agents |