Primary Prevention of Cardiovascular Disease (CVD) in Pre-diabetic & Pre-hypertensive Subjects
Overview[ - collapse ][ - ]
Purpose | 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 | Pre-diabetes Pre-hypertension |
Intervention | Drug: Metformin+Enalapril+Simvastatin Drug: Placebo tablet |
Phase | N/A |
Sponsor | Ramathibodi Hospital |
Responsible Party | Ramathibodi Hospital |
ClinicalTrials.gov Identifier | NCT01364675 |
First Received | May 31, 2011 |
Last Updated | June 1, 2011 |
Last verified | May 2011 |
Tracking Information[ + expand ][ + ]
First Received Date | May 31, 2011 |
---|---|
Last Updated Date | June 1, 2011 |
Start Date | January 2012 |
Estimated Primary Completion Date | December 2016 |
Current Primary Outcome Measures | Cardiovascular Events [Time Frame: 4-year] [Designated as safety issue: Yes]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) |
Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
Brief Title | Primary Prevention of Cardiovascular Disease (CVD) in Pre-diabetic & Pre-hypertensive Subjects |
---|---|
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 |
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. |
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 Type | Interventional |
Study Phase | N/A |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention |
Condition |
|
Intervention | 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-pillDrug: Placebo tablet Identical Placebo Tablet Other Names: Placebo |
Study Arm (s) |
|
Recruitment Information[ + expand ][ + ]
Recruitment Status | Not yet recruiting |
---|---|
Estimated Enrollment | 8900 |
Estimated Completion Date | December 2016 |
Estimated Primary Completion Date | July 2016 |
Eligibility 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 |
Gender | Both |
Ages | 50 Years |
Accepts Healthy Volunteers | Accepts Healthy Volunteers |
Contacts | Contact: Phisitt Vejakama, M.D. 66849562882 toughcountrydoc@gmail.com |
Location Countries | Thailand |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01364675 |
---|---|
Other Study ID Numbers | 12011 |
Has Data Monitoring Committee | Yes |
Information Provided By | Ramathibodi Hospital |
Study Sponsor | Ramathibodi Hospital |
Collaborators | Ubon Ratchathani Public Health Office, Thailand National Health Security Office, Thailand The Government Pharmaceutical Organization |
Investigators | Principal Investigator: Phisitt Vejakama, M.D. Section for clinical epidemiology and bioststistics, Faculty of medicine, Ramathibodi hospital |
Verification Date | May 2011 |
Locations[ + expand ][ + ]
Ubon ratchathani Public Health Office | Muang District, Ubon ratchathani, Thailand, 34000 Principal Investigator: Phisitt Vejakama, M.D.Not yet recruiting |
---|