CTRI/2011/05/001761Other2 期
Comparative Assessment of Tolerability, Efficacy and Safety of Combination of Compound CDRI 80/574 and Atorvastatin versus Atorvastatin in subjects with Hyperlipidemia (A Randomized, Double-blind, Parallel-group, Active-comparator Controlled, Phase II Clinical Study)
试验速览
- 阶段
- 2 期
- 状态
- Other
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- change in LDL-C, triglycerides and HDL-C from baseline to study close out
研究概览
简要总结
Comparative Assessment of Tolerability, Efficacy and Safety of Combination of Compound CDRI 80/574 and Atorvastatin versus Atorvastatin in subjects with Hyperlipidemia (A Randomized, Double-blind, Parallel-group, Active-comparator Controlled, Phase II Clinical Study)
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy volunteers 2.18-45 years of age 3.Either sex 4.Willing to give written informed consent.
排除标准
- •1.Known hypersensitivity or intolerance to the study drugs 2.Pregnant or lactating women 3.HIV positive subjects 4.Presence of liver disease: Serum bilirubin, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 1.5 times the upper limit of normal (ULN) 5.Presence of kidney disease: Serum Creatinine 1.5 times the ULN 6.Subjects with abnormal hematologic function (Hemoglobin ¡Ü 8gm/dl, WBC count ¡Ü3000/mm3, platelet count ¡Ü100,000/mm3).
- •7.Presence of systemic diseases such as seizure disorder, diabetes mellitus, congestive heart failure or malignancy 8.Subject with a pre-existing condition interfering with normal gastrointestinal anatomy or motility that could interfere with the absorption, metabolism, and/or excretion of the study drugs.
- •Subjects with a history of cholecystectomy will be excluded.
- •9.Evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
- •10.Resting heart rate of 100 beats/min or 60 beats/min on the screening day.
- •11.History of hypotensive episodes, or systolic blood pressure reading of 100 mm Hg or a diastolic reading of 60 mm Hg at time of general physical examination.
- •12.History of hypertension, or systolic blood pressure reading of 139 mm Hg or a diastolic reading 89 mm Hg at time of general physical examination.
- •13.Subject who have taken over the counter or prescribed medications, including any enzymes modifying drugs or any systemic medication within the past four weeks prior to start of clinical period.
- •14.Subjects receiving lipid-lowering therapy during 4 weeks preceding enrollment 15.Chronic alcoholic or drug abuse subjects 16.Heavy smokers (smoking 10 cigarettes/biddies/day) or mild to moderate smokers (smoking 10 cigarettes/biddies/day) who are not willing to discontinue smoking 48 hours before initiation of study and during the study period.
- •17.Subject who participated in any other clinical investigation using an experimental drug or have donated blood or had more than 300ml of blood drawn in the past 3 months.
- •18.Subject without adequate venous access to allow collection of all samples via venous cannula during the study.
- •19.Subjects unwilling or unable to comply with the study procedures.
结局指标
主要结局
change in LDL-C, triglycerides and HDL-C from baseline to study close out
时间窗: change in LDL-C, triglycerides and HDL-C from baseline to study close out
次要结局
- percentage change in other lipid parameters, including total cholesterol, apo B and apo A-1 from baseline to study close out and rate of dropouts due to treatment related adverse events(percentage change in other lipid parameters, including total cholesterol, apo B and apo A-1 from baseline to study close out and rate of dropouts due to treatment related adverse events)
研究者
研究点 (1)
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