PER-087-04已完成未知
A STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COADMINISTRATION OF EZETIMIBE / SIMVASTATIN AND PHENOFIBRATE IN PATIENTS WITH MIXED HYPERLIPIDEMIA
MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 0 人开始时间: 2005年2月21日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
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
- •The patient is 18 to 79 years of age.
- •The patient is a post-menopausal man or woman. The patient is a pre-menopausal woman who is surgically sterile or who is highly unlikely to conceive, and who has a negative pregnancy test at Visit 1.
- •The patient will follow a stable diet throughout the study.
- •The patient maintains a stable weight (± 2 kg) for> 6 weeks before Visit 1.
- •The patient has a LDL-C level of 130 to 220 mg / dL (3.37 to 5.70 mmol / L) if he / she does not have diabetes; LDL-C from 100 to 180 mg / dL (2.59 to 4.66 mmol / L) if you have diabetes.
- •The patient has a triglyceride level of 150 to 500 mg / dL (1.71 to 5.70 mmol / L). [according to the reference ranges of the central laboratory] in Visit 2.
- •The patient has a creatine phosphokinase (CPK) level <2 x the upper limit of normal (ULN) [according to the reference ranges of the central laboratory] in Visit 2.
- •The patient has a level of alanine aminotransferase (ALT), and aspartate aminotransferase (AST) <1.5 x the upper limit of normal (ULN) [according to the reference ranges of the central laboratory] in Visit 2.
排除标准
- •The patient has Chronic Class II or IV heart failure as defined by the New York Heart Association (NYHA).
- •The patient has uncontrolled cardiac arrhythmias.
- •The patient has a history of coronary heart disease (CHD), a disease equivalent to CHD, with the exception of diabetes mellitus, [for example, peripheral arterial disease (femoral, popliteal), abdominal aortic aneurysm, symptomatic carotid artery disease (TIA), stroke)] or risk of CHD> 20%, as indicated by the National Cholesterol Education Program (NCEP) ATP criteria (Appendix 4 and 5).
- •The patient has unstable hypertension (systolic blood pressure> 160 mm Hg or diastolic blood pressure> 100 mm Hg) at Visit 1.
- •The patient suffers from hematological, digestive or central nervous system disorders, including a degenerative disease that limits the evaluation or participation in the study.
- •The patient has inadequately controlled diabetes mellitus (HbAlc> 8.5%), or has recently been diagnosed (within 3 months), or has had a recent change in antidiabetic pharmacotherapy (ie, a change in dosage [a exception of ± 10 units of insulin] or the addition of a new medication) within 3 months of Visit 1.
- •The patient suffers from an uncontrolled endocrine or metabolic disease that is known to influence serum lipids or lipoproteins (ie, secondary causes of hyperlipidemia).
- •The patient suffers from homozygous familial hypercholesterolemia, type I or V hyperlipidemia, or receives an LDL apheresis treatment.
- •The patient has a history of cholelithiasis and has not undergone cholecystectomy.
- •The patient has an active or chronic hepatobiliary or hepatic disease.
- •The patient has a serum creatinine level> 1.5mg / dL (133 micromol / L) at Visit 1, nephrotic syndrome, or other clinically significant kidney disease.
- •The patient has a serum creatinine level of 1.1 to 1.5 mg / dL (97 to 133 micromol / L), and their creatinine clearance (calculated using the Cockroft-Gault formula, Appendix 3) is <50 mL / min .
- •The patient has a history of mental instability, drug / alcohol abuse within the last 5 years or a major psychiatric illness that is not adequately controlled and is unstable.
- •The patient has a condition or situation that, in the opinion of the investigator, may interfere with their participation in the study.
- •The patient is currently pregnant or breastfeeding.
- •The patient has a history of ileal bypass, gastric bypass, or other significant condition associated with malabsorption.
- •The patient has a positive HIV history.
- •The patient currently follows a vigorous exercise regimen that exceeds the level of daily exercises currently recommended by the American Heart Association / American Diabetes Association (eg, marathon training, muscle development training, intensive military reserve training, etc.)
- •The patient has a history of cancer within the last 5 years (with the exception of dermatological carcinoma of basal cells or squamous cells).
- •The patient is currently taking cardiovascular medications, such as beta-blockers, calcium channel blockers, AGE inhibitors, nitrates, α-adrenergic blockers, thiazide-type diuretics, non-anticoagulant angiotensin receptor antagonists (ie, warfarin), and NO have received, or will not receive, a stable dose for> 6 weeks prior to randomization (Visit 3).
- •The patient has been receiving treatment with orlistat, sibutramine, or another anti-obesity m
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