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.
试验速览
- 阶段
- 4 期
- 状态
- Other
- 入组人数
- 160
- 试验地点
- 5
- 主要终点
- Change in lipid profile (TC, LDL-C, HDL-C and TG)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Day(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •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).
排除标准
- •Patient with history of hypersensitivity to any statin, niacin or aspirin
- •Patients with uncontrolled diabetes
- •Patients with clinically unacceptable laboratory parameters
- •Patients with peptic ulcer disease
- •Patients with history of bleeding or coagulation disorder
- •Patients with compromised hepatic and renal function
- •Pregnant and lactating women
- •Women of child bearing age not practicing or not willing to use contraceptive
- •Patients experiencing post menopausal hot flashes
- •Mentally retarded patients
- •Patients not willing to sign written informed consent
- •Patients receiving hormone replacement therapy, high dose of antioxidant vitamin therapy or systemic corticosteroid therapy
- •Patients requiring concomitant therapy with other lipid lowering drugs
- •Patients who participated in clinical trial with in 30 days before enrollment into the study
- •Patients, for any reason who are considered to be unsuitable candidates by the investigator.
结局指标
主要结局
Change in lipid profile (TC, LDL-C, HDL-C and TG)
时间窗: Baseline Visit, 3rd Visit & End of Study Visit
次要结局
- 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)