A clinical trial to study the effects of two drugs, Fixed dose combination of tablets of Rosuvastatin 5 mg and Fenofibrate 160mg with Rosuvastatin 5mg alone in patients with dyslipidemia
Phase 3
Completed
- Registration Number
- CTRI/2010/091/000147
- Lead Sponsor
- M/s. Ravenbhel Healthcare Pvt. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
Male and female outpatients between 18-75 tears of age.
Patients having i. LDL cholesterol>130mg/dl ,ii.Serum triglycerides > or equal to 150mg/dl and < or equal to 500mg/dl.
Able to stop current statin therapy without risk to the patient
Patients who are able to adequately maintain diary.
Patients who are able and are willing to comply with the protocol and have signed IEC or IRB approved ICF
Exclusion Criteria
No willing to sign ICF, Hypersensitivity to statins, Serum triglyceride levels > 500mg/dl.Patients with hepatic disease, poorly controlled diabetes mellitus, patients familiar with muscular pain, myopathy.Stroke less than six months prior to informed consent. pregnancy and lactation, history of pancreatitis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method change from baseline values of LDL-C, serum triglycerides, HDL-CTimepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method Achievement of target levels of total cholesterolnd LDL cholesterol, patient complianceTimepoint: