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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01364675
Other study ID # 12011
Secondary ID
Status Not yet recruiting
Phase N/A
First received May 31, 2011
Last updated June 1, 2011
Start date January 2012
Est. completion date December 2016

Study information

Verified date May 2011
Source Ramathibodi Hospital
Contact Phisitt Vejakama, M.D.
Phone 66849562882
Email toughcountrydoc@gmail.com
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 8900
Est. completion date December 2016
Est. primary completion date July 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 50 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


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
Placebo tablet
Identical Placebo Tablet

Locations

Country Name City State
Thailand Ubon ratchathani Public Health Office Muang District Ubon ratchathani

Sponsors (4)

Lead Sponsor Collaborator
Ramathibodi Hospital National Health Security Office, Thailand, The Government Pharmaceutical Organization, Ubon Ratchathani Public Health Office, Thailand

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cardiovascular Events 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) 4-year Yes
Secondary Micro-vascular Complications Renal dysfunction, ESRD (on dialysis or kidney transplantation), Progression of Albuminuria, Retinopathy 4-year Yes
Secondary Cumulative Incidence of Diabetes 4-year Yes
Secondary Cumulative Incidence of Hypertension 4-year Yes
Secondary Incidence of Individual Cardiovascular Disease 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
4-year Yes
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