Main
|
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: |
|
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
|
Name:
|
|
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
|
|
Name:
|
|
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
|
| |
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 ID(s)
|
05_ENDO_46
|
Source(s) of Monetary Support
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|