ISRCTN22416062已完成不适用
An open-label, prospective, non-comparative clinical trial to evaluate the efficacy and safety of rosuvastatin in high risk Indian population with diabetes and dyslipidemia
Ranbaxy Laboratories Ltd (India)0 个研究点目标入组 360 人开始时间: 2007年11月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 360
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
- 性别
- All
入选标准
- •1. Diabetes type II defined by American Diabetes Association criteria of fasting venous plasma glucose of greater than or equal to 126 mg/dl, two-hour post prandial plasma glucose of greater than or equal to 200 mg/dl or already on treatment of diabetes
- •2. Dyslipidemia defined by Low Density Lipoprotein (LDL) cholesterol more than 100 mg/dl or on prior statin therapy
- •3. Age of greater than or equal to 30 and less than or equal to 70 years
- •4. Informed consent by the patient
排除标准
- •1. Failure to give informed consent
- •2. A history of hypersensitivity to statins
- •3. Evidence of fundoscopy grade 2 hypertensive or diabetic retinopathy
- •4. Serum creatinine greater than 1.5 mg/dl
- •5. Overt proteinuria
- •6. Pregnant or lactating mothers
- •7. Evidence/history of heart failure
- •8. Systolic blood pressure above 180 mmHg and diastolic blood pressure above 110 mmHg
- •9. Recent history of cerebrovascular disease, myocardial infarction, unstable angina, new onset Left Bundle Branch Block (LBBB) in the past 4 weeks
- •10. Documented case of homozygous familial hypercholesterolemia
- •11. Type I Diabetes Mellitus (DM)
- •12. Use of concomitant medications (cyclosporin, systemic itraconazole or ketoconazole, erythromycin, or clarithromycin, glucocorticoids or verapamil) known to affect the lipid profile or with potency safety concern
- •13. Recent ongoing inter-current infection/high sensitivity C-Reactive Protein (hsCRP) greater than 10 mg/L
- •14. Active liver disease or hepatic dysfunction (defined as Alanine aminotransferase [ALT], aspartate aminotransferase [AST], Gamma-Glutamyl Transferase [GGT], alkaline phosphate or bilirubin levels greater than or equal to 1.5 the upper limit of normal)
- •15. Diagnosed to have any other endocrinal or metabolic disease other than Type II DM that is known to influence serum lipids and lipoproteins
- •16. Patients having history suggestive of myalgia/myositis/arthralgia
- •17. Serious or unstable medical or psychological condition that could compromise the patient?s safety or successful trial participation
- •18. History of alcohol consumption greater than 2 drinks/day (30 ml) or 10 drinks per week
研究者
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Study to evaluate the efficacy and safety of rosuvastatin in indian population who have diabetes with abnormal lipid levels (dyslipidemia)Dyslipidemia in patients with Diabetes MellitusCardiovascular - Coronary heart diseaseACTRN12607000473460Ranbaxy Laboratories Ltd360
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