CTRI/2010/091/001490未知3 期
A Multicentric, Open-Label, Randomized, Comparative, Parallel-group, Active-Controlled Phase III Clinical Trial of the Safety and Efficacy of Fixed-dose combination capsules of Rosuvastatin 10 mg and Aspirin 150 mg with Rosuvastatin 10 mg alone in patients with dyslipidemia
M/s. GKM New Pharma4 个研究点 分布在 1 个国家目标入组 200 人开始时间: 待定
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- oChange from baseline values of LDL-C at the last visit at 12 weeks.oChange from baseline values of serum triglycerides at the last visit at 12 weeksoChange from baseline values of HDL-C at the last visit at 12 weeks
研究概览
简要总结
This study is A Multicentric, Open-Label, Randomized, Comparative, Parallel-group, Active-Controlled Phase III Clinical Trial of the Safety and Efficacy of Fixed-dose combination capsules of Rosuvastatin 10 mg and Aspirin 150 mg with Rosuvastatin 10 mg alone in patients with dyslipidemia that will be conducted in four centres in India
研究设计
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
入选标准
- •Male and female outpatients ³ 18 but < 75 years of age.
- •1.Patients with dyslipidemia meeting the following criteria.a.LDL Cholesterol > 130 mg/dL.
- •b.Serum Triglycerides > or equal to 150 mg/dL and < or equal to 500 mg/dL.2.Able to stop current statin therapy without risk to the patient.
- •3.Patients who are able and are willing to comply with the protocol and have signed IEC or IRB approved Informed Consent Form.4.Patients who are able to adequately maintain the diary.
排除标准
- •1.Not willing to sign the ICF,2.Hypersensitivity to statins.3.Serum Triglyceride levels > 500 mg/dL4.Patients with abnormal clinical chemistry, hematology, urinalysis, or ECG test results that are considered clinically significant by the investigator.5.Patients with significant hepatic disease (liver function tests x 2 upper limit of normal reference range) or significant renal disease (creatinine x 2 upper limit of normal reference range).6.Poorly controlled diabetes mellitus (glycosylated hemoglobin >8.0% )or diabetes mellitus requiring insulin therapy7.Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, patients post-renal transplant or with only one functioning kidney 8.Patients familiar with muscular pain, myopathy9.History of drug or alcohol dependency within the previous six months. Chronic administration of any medication known to affect blood pressure, other than the trial medication 10.Concurrent participation in another clinical trial or any investigational therapy within thirty days prior to signing the consent form. 11.Symptomatic congestive heart failure (New York Heart Academy (NYHA) functional class CHF III-IV).
- •unstable angina pectoris, myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery less than three months prior to informed consent 12.Stroke less than six months prior to informed consent 13.Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant arrhythmias as determined by the investigator.14.Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of Rosuvastatin 15.Patients with concomitant diseases such as malignancy, HIV 16.Pregnancy and lactation17.History of pancreatitis.
结局指标
主要结局
oChange from baseline values of LDL-C at the last visit at 12 weeks.oChange from baseline values of serum triglycerides at the last visit at 12 weeksoChange from baseline values of HDL-C at the last visit at 12 weeks
时间窗: 12 weeks
次要结局
- oAchievement of target levels of total cholesterol and LDL-cholesteroloNumber of patients achieving target levels of lipid levels ? treatment respondersoPatient compliance.(12 weeks)
研究者
研究点 (4)
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