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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 21 January 2013
Main ID:  EUCTR2004-005184-15-GB
Date of registration: 29/04/2005
Prospective Registration: Yes
Primary sponsor: Christie Hospital NHS Trust
Public title: Central Hypothyroidism and Adjusted Thyroxine dose Study (CHATS): impact of increasing free thyroxine levels in patients with hypopituitarism - CHATS
Scientific title: Central Hypothyroidism and Adjusted Thyroxine dose Study (CHATS): impact of increasing free thyroxine levels in patients with hypopituitarism - CHATS
Date of first enrolment: 24/05/2005
Target sample size: 80
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-005184-15
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: Single blind: Double blind: yes Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no  
Phase: 
Countries of recruitment
United Kingdom
Contacts
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Key inclusion & exclusion criteria
Inclusion criteria:
Patients aged 20-70 with hypopituitarism and free thyroxine levels within the lower third of the reference range
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

Exclusion criteria:
thyrotoxicosis, uncontrolled cardiac arrhythmias or unstable ischaemic heart disease, treatment with amiodarone/lithium within the last 6 months, acromegaly, Cushing's disease


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Central (secondary/tertiary) hypothyroidism (subclinical)
Intervention(s)

Trade Name: Levothyroxine
Product Name: Levothyroxine
Pharmaceutical Form: Capsule*
INN or Proposed INN: Levothyroxine
Concentration unit: µg microgram(s)
Concentration type: range
Concentration number: 25-100
Pharmaceutical form of the placebo: Capsule*

Primary Outcome(s)
Secondary Objective: Changes in cardiovascular parameters (24hour Holter ECG, carotid intima-media thickness), body composition (assessed by total body dual x-ray absorptiometry), lipid profile, creatine kinase, quality of life assessment by AGHDA (Adult Growth Hormone Deficiency Assessment) questionnaire, and thyroid symptom score
Primary end point(s): changes in quality of life assessed by SF-36, EQ-5D
Main Objective: Assessment of change in quality of life assessed by standard questionnaires (SF-36, EQ-5D)
Secondary Outcome(s)
Secondary ID(s)
05_ENDO_46
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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