EUCTR2004-000775-34-HU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9月28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
- •1. Male or female aged = 18 years
- •2. Documented 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. If this is
- •not the case, an initial blood sample should be taken and analysed at the local laboratory
- •to confirm this. These results should be confirmed at Screening Visit 1.
- •3. Female subjects 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)
- •4. In good physical and mental health as determined by a physician on the basis of medical
- •history, physical examination and laboratory results
- •5. Read and understood the Subject Information Sheet and signed the Informed Consent
- •At Visit 2/2.1 during Dietary Run-In subjects must be/have:
- •6. 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 subjects must have fulfilled the above
- •criteria and have:
- •7. 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
- •8. Pupils must dilate = 6mm.
- •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 subjects must not be/have:
- •1. Coronary heart disease (CHD) or CHD-risk factors comprised of:
- •1.1 Diabetes mellitus Type I or II
- •1.2 History 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
- •2. A body mass index (BMI) < 15 or > 35 kg/m2
- •3.A history or presence of:
- •1.1 Drug 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. For a definition of a unit of alcohol see section 9.11
- •1.2 Uncontrolled hypertension despite medical treatment (Stage 2 hypertension defined
- •as mean resting diastolic blood pressure > 100mmHg or mean resting systolic blood
- •pressure > 160mmHg)
- •1.3 Thyroid disease, particularly hyperthyroidism or subjects whose thyroid replacement
- •therapy was initiated within the last 3 months
- •1.4 HIV positive status, hepatitis B or C
- •1.5 Malignancy, except subjects whose malignancy has been diagnosed as Stage 1 basal
- •or squamous cell carcinoma
- •1.6 Heterozygous or homozygous familial hypercholesteroleamia or known Type III
- •hyperlipoproteinaemia (familial dysbetalipoproteinaemia)
- •1.7 Fibromyalgia, myopathy, rhabdomyolysis or unexplained muscle pain and/or
- •discontinuation of HMG-CoA reductase inhibitors due to myalgia
- •1.8 Trauma 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
- •1.9 A clinically significant food allergy that would prevent adherence to the specialised
- •4. Any other serious disease or condition that might affect life expectancy or make it
- •difficult to successfully manage and monitor the subject according to the protocol
- •5. A known hypersensitivity or history of adverse reaction to atorvastatin or to TAK-475
- •6. Taken any excluded medication (see Section 9.10) in the 30 days prior to Screening Visit
- •1 or be planning to take any for the duration of the study
- •7. Taking part in another investigational study or have been participating in an
- •investigational study within the 30 days prior to Screening Visit 1
- •8. Unable to give written informed consent for any reason
- •9. An ALT or AST level > 2 times the ULN, active liver disease, jaundice (bilirubin >1.5
- •times the ULN) or serum creatinine > 135 µmol/l (1.5 mg/dl), CPK > 3 times the ULN.
研究者
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