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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. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2005-001315-22-AT |
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Date of registration:
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18/01/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The effect of the cholinesterase inhibitor donepezil on organic and functional deficits related to growth hormone deficiency in old age.
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Scientific title:
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The effect of the cholinesterase inhibitor donepezil on organic and functional deficits related to growth hormone deficiency in old age. |
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Date of first enrolment:
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09/03/2006 |
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Target sample size:
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80 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-001315-22 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Countries of recruitment
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Austria
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
Healthy aging women and men aged 70 to 75 years.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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:
Sick sinus syndrome, atrioventricular block, sinuatrial block
Asthma brochiale, COPD
Gastric or duodenal ulcers
Urinary obstruction
Severe renal or hepatic impairment
Known hypersensitivity against the investigational drug
Medication with beta-blockers, cholinomemetica or NSAIDs
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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We plan to study healthy aging subjects.
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Intervention(s)
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Trade Name: Aricept
Product Name: Aricept
Product Code: Donepezil
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Gastroenteral use
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Primary Outcome(s)
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Main Objective: The main objective of the trial is to assess if the application of the cholinesterase inhibitor donezpezil results in an increase secretion of growth hormone and IGF-1 and if this effect is sustained.
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Secondary Objective: Seconary objectives are to investigate effects of an increased growth hormone/IGF-1 secretion on selected age related alterations of body composition and functional decline (e.g. bone mineral density, muscle function, fat mass, serum lipids, cognitive function, depression).
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Primary end point(s): IGF-1 serum levels
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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