EUCTR2004-000775-34-EE进行中（未招募）不适用
A double-blind, randomised, parallel group study to evaluate the safety, tolerability and efficacy of TAK-475 alone or co-administered with atorvastatin in patients with primary dyslipidemia - Not available
Takeda Europe R&D Centre Ltd0 个研究点目标入组 1,500 人开始时间: 2004年11月26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
- 1,500
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
- •At Screening Visit 1 in order to be eligible for enrolment patients must be/have:·
- •Male or female aged = 18 years.
- •History of dyslipidemia (fasting LDL-C levels = 160 mg/dL (4.15 mmol/L) and triglycerides < 400 mg/dL (4.52 mmol/L) within 30 days prior to screening. These results should be confirmed at screening
- •Female patients of child-bearing age must have undergone surgical sterilisation, hysterectomy, tubal ligation, bilateral oophorectomy or be post menopausal women (defined as amenorrhoea > 1yr due to menopause)·
- •In good physical and mental health as determined by a physician on the basis of medical history, physical examination and laboratory results·
- •Read and understood the Patient Information Sheet and signed the Informed Consent Form
- •At Visit 2/2.1 during the Dietary Run-In period patients must be/have:·Fasting LDL-C levels = 130 mg/dL (3.37 mmol/L) <190mg/dL (4.92mmol/L) and triglycerides < 400 mg/dL (4.52 mmol/L)At Randomisation Visit 3 in order to be randomised patients must have fulfilled the above criteria and have:·
- •A LOCS III assessment of nuclear opalescence less than or equal to 3.0, cortical cataract less than or equal to 2.0, posterior subcapsular cataract less than or equal to 1.0, and nuclear colour less than 3.0
- •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
- •At Screening Visit 1 to enter the 6-week Dietary Run-In period the patients must not be/have: ·
- •Coronary heart disease (CHD) or CHD-risk factors comprised of:
- •oDiabetes mellitus Type I or IIoHistory or presence of myocardial infarction, angina pectoris, unstable angina, coronary angioplasty, coronary or peripheral arterial surgery (bypass graft), aortic aneurysm, transient ischaemic attacks or cerebrovascular accident·
- •A body mass index (BMI) < 15 or > 35 kg/m2·
- •A history or presence of:
- •oDrug abuse (defined as illicit drug use) or a history of alcohol abuse(defined as routinely consumes > 21 units of alcohol per week) within the 2 years previous to screening
- •oUncontrolled hypertension (Stage 2 hypertension defined as mean resting diastolic blood pressure > 100mmHg or mean resting systolic blood pressure > 160mmHg)
- •oUncontrolled hyper- or hypothyroidism or patients whose thyroid replacement therapy was initiated within the last 3 months
- •oHIV positive status, liver disease, hepatitis B or CoMalignancy, except patients whose malignancy has been diagnosed as Stage 1 basal or squamous cell carcinoma
- •oHeterozygous or homozygous familial hypercholesteroleamia or known Type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia)
- •oFibromyalgia, myopathy, rhabdomyolysis or unexplained muscle pain and/or discontinuation of HMG-CoA reductase inhibitors due to myalgia
- •oTrauma to the eye or eye irradiation, glaucoma, iritis, uveitis, prior intraocular surgery, laser surgery to the iris, retinal photocoagulation, or laser trabeculoplasty, corneal opacification or other medial opacities, or has received LASIK refractive surgery within 6 months prior to Screening Visit 1
- •oA clinically significant food allergy that would prevent adherence to the specialised diet ·
- •Any other serious disease or condition that might affect life expectancy or make it difficult to successfully manage and monitor the patient according to the protocol
- •oA known hypersensitivity or history of adverse reaction to atorvastatin or to TAK-475
- •oTaken any excluded medication (see Section 9.10) in the 30 days prior to the Screening Visit 1 or be planning to take any for the duration of the study
- •oTaking part in another investigational study or have been participating in an investigational study within the 30 days prior to the Screening Visit 1
- •oUnable to give written informed consent for any reason
- •oAn ALT or AST level > 2 times the ULN, active liver disease, jaundice (bilirubin >1.5 times the ULN) or serum creatinine > 135 mmol/l (1.5 mg/dl), CPK > 3 times the ULN.
研究者
相似试验
进行中（未招募）
不适用
A double-blind, randomised, parallel group study to evaluate the safety, tolerability and efficacy of TAK-475 alone or co-administered with atorvastatin in patients with primary dyslipidemia - Not availableTreatment of patients with primary dyslipidemiaMedDRA version: 7Level: PTClassification code 10058108EUCTR2004-000775-34-CZTakeda Europe R&D Centre Ltd1,500
进行中（未招募）
不适用
A double-blind, randomised, parallel group study to evaluate the safety, tolerability and efficacy of TAK-475 alone or co-administered with atorvastatin in patients with primary dyslipidemia - Not availableTreatment of patients with primary dyslipidemiaMedDRA version: 7Level: PTClassification code 10058108EUCTR2004-000775-34-LTTakeda Europe R&D Centre Ltd1,500
进行中（未招募）
1 期
A double-blind, randomised, parallel group study to evaluate the safety, tolerability and efficacy of TAK-475 alone or co-administered with atorvastatin in patients with primary dyslipidemia - Not availableTreatment of patients with primary dyslipidemiaMedDRA version: 7 Level: PT Classification code 10058108EUCTR2004-000775-34-GBTakeda Europe R&D Centre Ltd
进行中（未招募）
1 期
A double-blind, randomised, parallel group study to evaluate the safety, tolerability and efficacy of TAK-475 alone or co-administered with atorvastatin in patients with primary dyslipidemia - Not availableTreatment of patients with primary dyslipidemiaMedDRA version: 7Level: PTClassification code 10058108EUCTR2004-000775-34-SKTakeda Europe R&D Centre Ltd1,500
进行中（未招募）
不适用
A double-blind, randomised, parallel group study to evaluate the safety, tolerability and efficacy of TAK-475 alone or co-administered with atorvastatin in patients with primary dyslipidemia - Not availableEUCTR2004-000775-34-HUTakeda Europe R&D Centre Ltd1,500