CTRI/2011/091/000030Other4 期
A randomized, double blind, comparative, multicentric study evaluating efficacy and tolerability of Extended Release Niacin and Rosuvastatin vs Matching placebo and Rosuvastatin in patients with Mixed Dyslipidemia.
试验速览
- 阶段
- 4 期
- 状态
- Other
- 入组人数
- 60
- 试验地点
- 1
- 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, 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(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
- •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.
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 time for flushing(During Entire Study Period)
- Median duration of flushing(During Entire Study Period)
研究者
研究点 (1)
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