EUCTR2012-000575-17-HR进行中（未招募）不适用
A phase III, two-armed, randomised, double blind, parallel study to compare the efficacy and safety in high CHD-risk patients with mixed dyslipidaemia of a 12-week administration of a fixed dose combination of Fenofibrate 160 mg and Pravastatin 40 mg (PRAVAFENIX®) versus Atorvastatin 20 mg. - PART
ABORATOIRES SMB S.A.0 个研究点目标入组 430 人开始时间: 2014年9月3日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 430
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
- •Patients with HDL-C < 40 mg/dl for male and HDL-C< 50 mg/dl for
- •female at the laboratory sample taken one week before the
- •randomization visit (B2)
- •Patients with TG > or equal to 150 mg/dl and < or equal to 600 mg/dl at the laboratory
- •sample taken one week before the randomization visit (B2)
- •Patients with LDL-C < 100 mg/dl at the laboratory sample taken one
- •week before the randomization visit (B2)
- •Patients still respecting the other selection criteria
- •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 408
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 22
排除标准
- •-Secondary or iatrogenic dyslipidaemia
- •-Dyslipidaemia type I-IIa-IV-V
- •-Personal history of myopathy and/or rhabdomyolysis with statins
- •and/or fibrates or confirmed CPK elevation > 5X ULN under previous statin treatment or at the selection and randomization visits
- •-Moderate to severe renal impairment (defined as an estimated
- •creatinine clearance < 60 ml/min) at the selection and randomization
- •-Severe hepatic impairment including biliary cirrhosis or active liver
- •disease including unexplained persistent elevations in liver function
- •tests (including ASAT/SGOT or ALAT/SGPT elevation exceeding 3X ULN)
- •at the selection and randomization visits
- •-Gallbladder disease
- •-Chronic or acute pancreatitis
- •-Patients who had an acute cardiovascular episode within the 3 months
- •prior to the start of the trial, or with a history of coronary angioplasty
- •with mounting of a stent within the past 6 months
- •-Uncontrolled hypertension (SBP > 160 mmHg or DBP > 95 mmHg)
- •under blood pressure treatment
- •-Uncontrolled primary hypothyroidism
- •-Uncontrolled diabetes with HbA1c > 8.5%
- •-Diabetes requiring insulin
- •-Evidence of any other unstable or untreated clinically significant
- •immunological, neoplastic, endocrine, haematological, gastrointestinal,
- •neurological or psychiatric abnormalities or medical disease
- •-Non adherence to a stable standardized diet during the study
- •-Patients with high alcohol consumption (above 21 beverages per week or with a recent history of alcoholism : one alcoholic beverage is defined as 30 ml distilled spirits, 120 ml wine, or 330 ml beer)
- •-Patients with poor cognitive function
- •-Hypersensitivity to the active substances or to any of the excipients
- •-Known photo allergy or photo toxic reaction during treatment with fibrates or ketoprofen
- •-Use of any of the prohibited medication as detailed in the non-permitted medication section
- •-Participation in any other clinical trial within 3 months before the selection visit
- •-Woman of childbearing potential not using an appropriate contraceptive method
- •-Pregnancy and breast feeding
- •-Patient not covered by Health Insurance System and / or not in compliance with the recommendations of National Law in force
- •-Compliance <80% during the run-in phase
- •-Presence of any other condition or illness, which, in the opinion of the investigator would interfere with optimal participation in the study and likely to jeopardize the planned termination of the study
研究者
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