CTRI/2010/091/001490招募中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 Pharma0 个研究点目标入组 200 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
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/dL
- •4.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 therapy
- •7.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, myopathy
- •9.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 lactation
- •17.History of pancreatitis
研究者
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