A clinical trial to study the effects of combination of atorvastatin and ezetemibe and compare it with atorvastatin only
- Registration Number
- CTRI/2010/091/000003
- Lead Sponsor
- I
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Patient of either sex of age 18-70 years
- Fasting LDL-C > or = 100 mg/dl in patients with CHD or CHD risk equivalents (Diabetes mellitus/ Peripheral arterial disease/ Carotid artery disease/ Abdominal aortic aneurysm) or
Fasting LDL-C > or = 130 mg/dl in patients with > or = 2 major risk factors for development of CHD having 10-20% ten year absolute CHD risk and on therapeutic lifestyle changes (TLC) for 3 months
- Patient taking low dose atorvastatin (10 mg) OD or patient not taking any hypolipidemic drug
- Able to provide written informed consent
- Fasting serum triglyceride (TG) level ≥350 mg/dl
- Medical history of systemic infection within 6 weeks of study initiation
- Medical history of unstable angina, myocardial infarction, heart failure or stroke within 3 months of the study
- Uncontrolled hypertension (systolic blood pressure >160 mm Hg and/or diastolic blood pressure >100 mm Hg)
- Uncontrolled diabetes mellitus (FBS > 300 mg/dl in patients with diabetes)
- ALT and AST > 2 x upper limit of normal
- Impaired renal function (creatinine > or = 2.0 mg/dl)
- Suffering from malabsorption syndrome or inflammatory bowel disease
- Pregnancy/Lactation
- Alcoholism
- Patients on drugs that can increase the incidence of statin induced myopathy
- Patient on chronic anti-inflammatory or antioxidant drugs within 6 weeks of study initiation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in LDL-C between two groupsTimepoint: 1. At baseline 2. At post treatment after 4 weeks
- Secondary Outcome Measures
Name Time Method 1. Serum sICAM<br><br>2. Serum hsCRP<br><br>3. Serum oxidized LDL<br><br>4. Adverse eventsTimepoint: 1. At Baseline<br><br>2. After 4 weeks of treatment