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.

Troikaa Pharmaceuticals Ltd0 个研究点目标入组 160 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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)

•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
•11. Patients experiencing post menopausal hot flashes
•12. Mentally retarded patients
•13. Patients not willing to sign written informed consent
•14. Patients receiving hormone replacement therapy, high dose of antioxidant vitamin therapy or systemic corticosteroid therapy
•15. Patients requiring concomitant therapy with other lipid lowering drugs
•16. Patients who participated in clinical trial with in 30 days before enrollment into the study
•17. Patients, for any reason who are considered to be unsuitable candidates by the investigator.

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