EUCTR2010-018663-42-IT进行中（未招募）不适用
Substitutive therapy of hypothyroid patients with L-thyroxine (T4) plus T3 sulfate (T3S). A Phase II, open-label, single centre, parallel group study on therapeutic efficacy and tolerability - ND
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- BRACCO
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 will be enrolled if they meet all the following inclusion criteria: written informed consent obtained; outpatients of either sex, aged between 18 and 70 years; hypothyroid for any raison, in T4 substitutive therapy (daily dose: 100/125/150 mcg); undetectable Tg (<5) (absence of endogenous thyroid hormones production); acceptable metabolic control (FT4, FT3 and TSH values inside the normal ranges); patient’s co-operative attitude and able to understand and adhere to study protocol procedures and timelines.
- •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
- •Patients will not be enrolled if they meet any of the following exclusion criteria: history or current evidence of cardiovascular diseases, e.g. congestive heart failure NYHA class > 1, coronary artery disease, myocardial infarction, severe hypertension, cardiac arrhythmias; history or current evidence of significant liver (i.e. AST/ALT higher than twice the upper limit of normal range) or renal (i.e. creatinine > 2 mg/dl) insufficiency, of metabolic or endocrine diseases (e.g. uncontrolled diabetes mellitus), or of any other underlying medical condition that might interfere with the study evaluation parameters; assumption of drugs affecting thyroid hormone GI absorption or metabolism; any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or postdose follow-up examinations; immunocompromised patients; malignant disease or any other disease with life expectancy less than 2 years; history of alcoholism, drug abuse, psychological or other psychiatric diseases that could invalidate informed consent or limit the subject compliance with protocol requirements; artificial or parenteral feeding; allergy, sensitivity or intolerance to study drugs and/or any of study drug formulation ingredients; pregnant or breastfeeding females, or those females not practicing adequate contraceptive measures; patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study; patients who received any investigational drug within the last 3 months; patients who have been previously enrolled in this study; employees of the investigator or study centre (i.e., principal investigator, sub-investigator, study coordinators, other study staff, employees, or contractors of each), with direct involvement in the proposed study or other studies under the direction of that investigator and/or study centre, as well as family members of the employees or the investigator.
研究者
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