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Main
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Note: This record shows only the 20 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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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00428792 |
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Date of registration:
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29/01/2007 |
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Primary sponsor: |
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Public title:
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Safety and Efficacy of Methylphenidate in Children With Attention-deficit Hyperactivity Disorder (ADHD)
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Scientific title:
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An Open-label, Randomized, Rater-blinded, Cross-over, Multicenter Study Comparing the Clinical Efficacy of Methylphenidate (Immediate Release/Extended Release) Treatment (20 or 40 mg Orally od) in Children With Attention-Deficit Hyperactivity Disorder (ADHD) Under Different Breakfast Conditions Over Two Weeks |
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Date of first enrolment:
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April 2007 |
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Target sample size:
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150 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00428792 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Germany
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Contacts
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Name:
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Novartis Pharma |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Pharmaceuticals |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Children aged 6-12
- Diagnosis of Attention-Deficit Hyperactivity Disorder (ADHD)
- Current medication with either 20 mg or 40 mg immediate release methylphenidate
Exclusion Criteria:
- Concomitant psychiatric disorders requiring pharmacological treatment
- Concomitant severe somatic disorders
- Eating disorders
- Addiction disorders
- Very high or low body weight according to age
- Known hypersensitivity to methylphenidate
- Contraindications for methylphenidate
Other protocol-defined inclusion/exclusion criteria applied to the study.
Age minimum:
6 Years
Age maximum:
12 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Attention Deficit Hyperactivity Disorder
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Intervention(s)
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Drug: Methylphenidate 20 mg long-acting capsules
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Primary Outcome(s)
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Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Teacher Rating in the Intent-to-Treat (ITT) Population
[Time Frame: Friday of each of the 2 treatment weeks]
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Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Teacher Rating in the Per Protocol (PP) Population
[Time Frame: Friday of each of the 2 treatment weeks]
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Secondary Outcome(s)
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10-Minute Math Test - Problems Attempted
[Time Frame: Saturday of each of the 2 treatment weeks]
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10-Minute Math Test - Problems Solved
[Time Frame: Saturday of each of the 2 treatment weeks]
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Clinical Global Impression (CGI-I) Scale Score - Physician Rating of Improvement (Change in State)
[Time Frame: Saturday of each of the 2 treatment weeks]
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Clinical Global Impression Severity (CGI-S) Scale Score - Physician Rating of Severity
[Time Frame: Saturday of each of the 2 treatment weeks]
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Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Attention Deficit Subscale Teacher Rating
[Time Frame: Friday of each of the 2 treatment weeks]
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Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Hyperactivity Subscale Teacher Rating
[Time Frame: Friday of each of the 2 treatment weeks]
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Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Impulsiveness Subscale Teacher Rating
[Time Frame: Friday of each of the 2 treatment weeks]
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Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Parent Rating
[Time Frame: Saturday of each of the 2 treatment weeks]
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Secondary ID(s)
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CRIT124DDE04
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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