To determine the efficacy and safety of a combination of Extended Release (ER) Niacin and Rosuvastatin as compared with Matching placebo and Rosuvastatin in patients with Mixed Dyslipidemia.

Phase 4

• Conditions: Mixed Dyslipidemia

• Registration Number: CTRI/2011/091/000030
• Lead Sponsor: Troikaa Pharmaceuticals Ltd

Brief Summary

This study is a randomized, double blind, comparative study evaluating efficacy and tolerability of Extended Release Niacin and Rosuvastatin vs matching placebo and Rosuvastatin in patients with Mixed Dyslipidemia. All patients will be randomly divided in two Groups. Patient will be received either Niacin and rosuvastatin or matching Placebo and Rosuvastatin according to randomization number. Change in lipid profile will be measured at various time points. Primary outcomes like Incidence and Severity of Flushing will be measured during the conduct of study.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-17
• Last Update Posted: 2013-02-15

Recruitment & Eligibility

• Status: Other
• Sex: All
• Target Recruitment: 60

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 diabetes3.Patients with clinically unacceptable laboratory parameters4.Patients with peptic ulcer disease5.Patients with history of bleeding or coagulation disorder6.Patients requiring hospitalization7.Patient with history of hypotension8.Patients with compromised hepatic and renal function9.Pregnant and lactating women10.Women of child bearing age not practicing or not willing to use contraceptive11.Patients experiencing post menopausal hot flashes12.Mentally retarded patients13.Patients not willing to sign written informed consent14.Patients receiving hormone replacement therapy, high dose of antioxidant vitamin therapy or systemic corticosteroid therapy15.Patients requiring concomitant therapy with other lipid lowering drugs16.Patients who participated in clinical trial with in 30 days before enrollment into the study17.Patients, for any reason who are considered to be unsuitable candidates by the investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in lipid profile (TC, LDL-C, HDL-C and TG)	Baseline Visit, 3rd Visit & End of Study Visit

Secondary Outcome Measures

Name	Time	Method
Drop out rate because of flushing	During entire Study Period
Median time for flushing	During Entire Study Period
Median duration of flushing	During Entire Study Period

Trial Locations

Locations (1)

B.Y.L. Nair ch. Hospital & T. N. Medical College; 🇮🇳 Mumbai, MAHARASHTRA, India

B.Y.L. Nair ch. Hospital & T. N. Medical College

🇮🇳Mumbai, MAHARASHTRA, India

Dr Girish C Rajadhyaksha

Principal investigator

9821695349

girishraj63@hotmail.com