A prospective, randomized, single-blind, placebo-controlled, two-armed, phase IV study in patients with subclinical hypothyroidism treated over 52 weeks either with levothyroxine in adjusted dosing to a serum TSH target value of 1,0 mU/L +/- 0,5 mU/L or with placebo in the control group. - IIT2010 - Levothyroxine Study

Institut für klinische Forschung und Entwicklung Berlin GmbH am St. Hedwig Krankenhaus0 个研究点开始时间: 2011年2月21日最近更新: 2013年8月19日

适应症

试验速览

暂无简介。

•1.Male or female, 18 - 64 years old at screening
•2.Serum TSH 3 - 10 mU/L and fT3 and fT4 in normal range at screening
•3.Willing and able to provide written informed consent and to participate in all study specific procedures
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 120
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1.Known clinically significant thyroid diseases requiring treatment
•2.Use of any thyroid medication 8 weeks before screening
•3.Pregnant or breastfeeding patients or patients planning to become pregnant in the next year
•4.Symptomatic coronary artery disease, heart failure, tachycardic arrhythmia
•5.Severe depression or other psychiatric disorders requiring treatment
•6.Medication with a significant impact on thyroid function (see Appedix 2)
•7.Clinically significant abnormal laboratory values at screening
•8.Patients with galactose intolerance, lactase deficiency or glucose-galactose malabsorption
•9.Participation in another study in the last 30 days before screening
•10.Alcohol and/or drug abuse or dependence
•11. Severe illnesses (such as cancer, clinically significant cardiovascular, gastrointestinal, pulmonary, endocrinological, neurological, psychiatric disorders), which would compromise the patient´s safety during the study
•12.MMSE test score < 18
•13.Insufficient knowledge of German to understand the questionnaires
•14.Other factors (such as psychosocial stress, administrative factors, inadequate understanding of the study), which would compromise a successful participation in the clinical study

发起方

Institut für klinische Forschung und Entwicklung Berlin GmbH am St. Hedwig Krankenhaus