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Sponsored by: |
Medice Arzneimittel Pütter GmbH & Co KG |
Information provided by: | Medice Arzneimittel Pütter GmbH & Co KG |
ClinicalTrials.gov Identifier: | NCT00619840 |
Investigation of efficacy and tolerability of extended-release MPD in adults with ADHD, compared with a placebo, and to acquire knowledge through long-term observation of adults
Condition | Intervention | Phase |
Attention Deficit Hyperactivity Disorder |
Drug: methylphenidate hydrochloride Drug: Placebo |
Phase III |
MedlinePlus related topics: | Attention Deficit Hyperactivity Disorder |
ChemIDplus related topics: | Methylphenidate hydrochloride Methylphenidate |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Placebo-Controlled Multi-Centre Double-Blind Trial for Adults With Extended-Release Methylphenidate for ADHD |
Enrollment: | 363 |
Study Start Date: | November 2004 |
Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator |
Drug: methylphenidate hydrochloride
sustained release, 10 mg capsule 1-3 capsules twice daily according to an individual titration schedule
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2: Placebo Comparator |
Drug: Placebo
10 mg capsule 1-3 capsules twice daily according to an individual titration schedule
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany, Sarland | |||||
Institute of Forensic Psychology and Psychiatry | |||||
Homburg/Saar, Sarland, Germany, 66421 |
Medice Arzneimittel Pütter GmbH & Co KG |
Principal Investigator: | Michael Rösler, Prof. Dr. | Institute of Forensic Psychology and Psychiatry, University of Saarland |
Responsible Party: | Medice Arzneimittel Pütter GmbH & Co. KG ( Dr. Roland Fischer/Head of Medical Dept. ) |
Study ID Numbers: | 6520-9979-06 |
First Received: | February 11, 2008 |
Last Updated: | February 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00619840 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
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