CTRI/2010/091/003016
Other
Phase 4
A randomized, open label, comparative, multicentric study evaluating efficacy and tolerability of Extended Release Niacin and Rosuvastatin vs Rosuvastatin alone in patients with Mixed Dyslipidemia.
Overview
- Phase
- Phase 4
- Status
- Other
- Sponsor
- Troikaa Pharmaceuticals Ltd
- Enrollment
- 160
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1\.Patients in the age group of 18\-75 years suffering from Mixed dyslipidemia
- •2\.Patients with LDL\-C level \> 130 mg/dL
- •3\.Patients with HDL\-C level \< 40 mg/dL
- •4\.Patients requiring Rosuvastatin therapy (already receiving Rosuvastatin or recently started)
Exclusion Criteria
- •1\. Patient with history of hypersensitivity to any statin, niacin or aspirin
- •2\. Patients with uncontrolled diabetes
- •3\. Patients with clinically unacceptable laboratory parameters
- •4\. Patients with peptic ulcer disease
- •5\. Patients with history of bleeding or coagulation disorder
- •6\. Patients requiring hospitalization
- •7\. Patient with history of hypotension
- •8\. Patients with compromised hepatic and renal function
- •9\. Pregnant and lactating women
- •10\. Women of child bearing age not practicing or not willing to use contraceptive
Investigators
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