EUCTR2005-005185-36-CZ进行中（未招募）1 期
AN OPEN-LABEL PHASE III, STUDY TO EVALUATE THE SAFETY OF THE COMBINATION (FENOFIBRATE / PRAVASTATIN 160-40 MG) DURING 24 WEEKS, IN HIGH VASCULAR RISK PATIENTS WITH COMBINED HYPERLIPIDEMIA - PRAVAFEN SAFETY
aboratoires SMB S.A.0 个研究点目标入组 330 人开始时间: 2006年1月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 330
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female, 18 years and older
- •High vascular risk patients according to the NCEP ATP III definitions with combined hyperlipidemia
- •Patients following a standardized diet for at least three months before the screening visit to be maintained stable throughout the study.
- •Patients taking a statin therapy for at least 8 weeks (stable dose) at the selection visit
- •Provide written, informed consent to participate in the study, indicated by a personal signature and date on the patient consent form
- •If the patient is female and of childbearing potential, she must be using an efficient mean of birth control, as determined by the investigator and provide a negative serum pregnancy test at the selection visit.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Secondary or iatrogenic dyslipidemia
- •Hyperlipidemia type I-IIa-IV-V
- •Abnormal liver function
- •CPK > 3x ULN
- •Abnormal renal function
- •Uncontrolled hypertension, as defined by SBP > 160 mm Hg or DBP > 95 mmHg under blood pressure treatment
- •Evidence of any other unstable or untreated clinically significant immunological, neoplastic, endocrine, haematological, gastrointestinal, neurological or psychiatric abnormalities or medical disease
- •Uncontrolled primary hypothyroidism
- •Uncontrolled diabetes with Hb1Ac > 8.5%
- •Use of any of the prohibited medication as detailed in the concomitant medication section
- •Patients with poor cognitive function
- •Participation in any other clinical trial within 3 months of the selection visit
- •Childbearing potential woman not using an appropriate contraceptive method, pregnant or breastfeeding woman
- •Patients with a biliary tract disease
- •Patients with high alcohol consumption or with a recent history of alcoholism
- •Patients with a personal or family history of hereditary muscle disease
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