CTRI/2010/091/000147
Completed
Phase 3
A multicentric, open label, randomized, comparative, parallel group, active controlled Phase III clinical trial of the safety and efficacy of Fixed dose combination of tablets of Rosuvastatin 5 mg and Fenofibrate 160mg with Rosuvastatin 5mg alone in patients with dyslipidemia
M/s. Ravenbhel Healthcare Pvt. Ltd.0 sites200 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- M/s. Ravenbhel Healthcare Pvt. Ltd.
- Enrollment
- 200
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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