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Main
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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: |
EUCTR2004-003340-22-LV |
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Date of registration:
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29/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A randomised, placebo controlled, double blind trial of asenapine in the prevention of relapse after long term treatment of schizophrenia.
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Scientific title:
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A randomised, placebo controlled, double blind trial of asenapine in the prevention of relapse after long term treatment of schizophrenia. |
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Date of first enrolment:
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19/09/2005 |
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Target sample size:
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447 |
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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:2004-003340-22 |
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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: yes
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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Latvia
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. at least 18 years of age,
2. signed informed consent,
3. a male, or a woman who is not of child-bearing potential (and breastfeeding),
4. fluent in the language of an investigator and study staff,
5. having a caregiver or an identified responsible person,
6. having access to appropriate supervision during the randomized treatment period,
7. primary diagnosis of schizophreania
8. documented history of at least 1 year episode of acute schizophrenia
9. antipsychotic treatment required for at least 2 years
etc.
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:
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Schizophrenia
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Intervention(s)
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Product Name: Asenapine maleate
Product Code: Org 5222
Pharmaceutical Form: Tablet
INN or Proposed INN: Asenapine maleate
CAS Number: 85650-56-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
INN or Proposed INN: Asenapine maleate
CAS Number: 85650-56-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Sublingual use
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Primary Outcome(s)
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Main Objective: To determine the efficacy of asenapine compared to placebo with respect to the time to an impending relapse in schizophrenia subjects who received treatment with asenapine for 26 weeks.
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Primary end point(s):
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Secondary Objective: To compare asenapine and placebo treatment for up to 1 year in schizophrenia subjects previously treated with asenapine for 26 weeks with respect to:
1. the 5 dimensions of schizophrenia
2. overall clinical impression of severity and imrpovement
3. depressive symptoms
4. suidical thinking
5. cognitive function, as assessed with a computerised cognitive battery
6. safety and tolerability
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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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