EUCTR2005-003626-26-GB进行中（未招募）不适用
A double-blind, placebo-controlled, randomized study to evaluate the efficacy and safety of TAK-475 or placebo when co-administered with current lipid-lowering therapy in subjects with homozygous familial hypercholesterolemia
Takeda Europe R&D Centre Ltd0 个研究点目标入组 40 人开始时间: 2005年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
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. Subjects must be at least 8 years of age and weigh = 30kg
- •2. Subjects must have homozygous FH documented by genetic testing confirming 2
- •mutated alleles at the LDL-receptor locus or by the following clinical criteria (both
- •criteria must be satisfied):
- •Subjects must have documented history of untreated fasting serum LDL > 460
- •mg/dL (11.91 mmol/L)
- •Tendinous xanthomas and/or corneal arcus before 10 years of age and /or
- •premature coronary heart disease before 20 years of age.
- •3. Subjects must have read and understood the Subject Information Sheet / Informed Consent and signed the Informed Consent Form. If the subject is considered a minor, a minor assent form should be executed by the minor and a parent or legal guardian must also give their full consent in writing in accordance with applicable laws and regulations.
- •4. Subjects must have been taking a stable, approved lipid-lowering drug regimen for a minimum of 8 weeks prior to Screening Visit 1 and will continue to do so for the
- •duration of the study.
- •5. If female and of childbearing potential, the subject is not pregnant, not lactating, not planning on becoming pregnant and agrees to use adequate contraception (as defined in the informed consent form) between Screening Visit 1 and 30 days following the last dose of study medication.
- •6. The subject is capable of understanding and complying with protocol requirements.
- •Are the trial subjects under 18? yes
- •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
- •1. The subject has an alanine aminotransferase (ALT) or aspartate aminotransferase
- •(AST) levels > 2 times the upper limit of normal (ULN), active liver disease,
- •jaundice, or serum creatinine > 135 µmol/L (1.5mg/dL) at screening.
- •2. The subject has a CPK > 3 times the ULN at screening. A repeat test for any of these tests described in the first two criteria is permitted and is at the discretion of the investigator.
- •3. The subject has a positive hepatitis B surface antigen, or hepatitis C virus antibody, as determined by medical history and/or subject’s verbal report.
- •4. The subject has a positive human immunodeficiency virus (HIV) status or is taking
- •antiretroviral medications, as determined by medical history and/or subject’s verbal
- •5. The subject is unable or unwilling to discontinue excluded medications (see Section
- •7.4) or to continue stable doses of stable dose” medications or would require treatment with any excluded medication during the study.
- •6. The subject is currently participating in another investigational study or has
- •participated in an investigational study within the past 30 days or, for drugs with a
- •long half-life, within a period of less than 5 times the drug’s half-life.
- •7. The subject has a previous history of cancer that has been in remission for less than 5 years prior to the first dose of study drug. This criterion does not include those subjects with basal cell or Stage 1 squamous cell carcinoma of the skin.
- •8. The subject has known hypersensitivity or history of adverse reaction to TAK-475.
- •9. The subject has a history of fibromyalgia, myopathy, rhabdomyolysis or unexplained muscle pain.
- •10. The subject has an endocrine disorder, such as Cushing’s Syndrome,
- •hyperthyroidism, or inappropriately treated hypothyroidism, affecting lipid
- •metabolism. Subjects with hypothyroidism on appropriate replacement therapy
- •(defined as stable thyroid hormone replacement therapy at least 3 months prior to
- •Visit 1 and TSH levels < 1.5 x ULN) will be eligible for enrollment. If the subject’s
- •TSH is >1.5 x ULN, a free T4 level will be determined and if the free T4 is within
- •normal limits the subject may continue in the study.
- •11. The subject has uncontrolled hypertension despite medical treatment (defined for
- •adults as mean resting diastolic blood pressure >100 mm Hg or mean resting systolic
- •blood pressure >160 mm Hg) at Screening Visit 1.
- •12. The subject has inflammatory bowel disease or any other malabsorption syndrome or has had gastric bypass or any other surgical procedure for weight loss.
- •13. The subject has a history of drug abuse (defined as illicit drug use) or a history of
- •alcohol abuse (defined as regular or daily consumption of more than 2 alcoholic
- •drinks per day) within the past 2 years.
- •14. The subject is unable to understand verbal or written English or any other language for which a certified translation of the approved informed consent (including minor assent) is available.
- •15. The subject has any other serious disease or condition at screening or at
- •randomization that might reduce life expectancy, impair successful management according to the protocol or make the subject an unsuitable candidate to receive
- •study drug.
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