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

Phase 4

• Conditions: Mixed Dyslipidemia

• Registration Number: CTRI/2010/091/003016
• Lead Sponsor: Troikaa Pharmaceuticals Ltd

Brief Summary

This study is 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 at multiple sites in India. All patients will be randomly divided in two Groups. Patients in Group A will receives niacin along with Rosuvastatin. Dose of Rosuvastatin will be given as per investigator discretion. Dose of Niacin will be gradually titrated to receive 1500 mg at 4 weeks. Patients in Group B will be received Rosuvastatin alone in doses to be required for achieving target LDL-C level as per discretion of the investigator/treating physician. Change in lipid profile will be measured at various time points. Primary outcomes like Change in lipid profile & Incidence and Severity of Flushing will be measured during the conduct of study.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-25
• Last Update Posted: 2013-02-28

Recruitment & Eligibility

• Status: Other
• Sex: All
• Target Recruitment: 160

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

• 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 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.

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 duration of flushing	During Entire Study Period
Median time for flushing	During Entire Study Period

Trial Locations

Locations (5)

B.J. Medical College, Civil Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Dr. Jayesh Rawal's Clinic; 🇮🇳 Ahmadabad, GUJARAT, India

Heart First Cardiac and Vascular Centre; 🇮🇳 Surat, GUJARAT, India

Sarjan Hospital; 🇮🇳 Udaipur, RAJASTHAN, India

Shree Hari Diabetes Foundation Centre.; 🇮🇳 Mysore, KARNATAKA, India

B.J. Medical College, Civil Hospital

🇮🇳Ahmadabad, GUJARAT, India

Dr. Kartikeya Parmar

Principal investigator

91-9924643799

drkartik@gmail.com