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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00475735 |
The purpose of this study is to investigate the safety and efficacy of an investigational treatment for Attention Deficit Hyperactivity Disorder (ADHD) when compared to placebo.
Condition | Intervention | Phase |
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Attention-Deficit/Hyperactivity Disorder (ADHD) |
Drug: MK0249 Drug: Comparator: methylphenidate Drug: Comparator: Placebo (unspecified) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Incomplete Block, Two-Period, Crossover Clinical Trial to Study the Safety and Efficacy of MK0249, 10 mg, for Adult Patients, Ages 18 to 55, With Attention Deficit Hyperactivity Disorder (ADHD) |
Enrollment: | 48 |
Study Start Date: | July 2007 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Arm 1: drug
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Drug: MK0249
MK0249 5mg tablet bid. Total time in the study will be ~10 weeks.
Drug: Comparator: Placebo (unspecified)
Methylphenidate 18mg encapsulated Pbo tablet up to qid. Total time in the study will be ~10 weeks.
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2: Active Comparator
Arm 2: Active comparator
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Drug: Comparator: methylphenidate
methylphenidate 18mg encapsulated tablet up to qid. Total time in the study will be ~10 weeks.
Drug: Comparator: Placebo (unspecified)
MK0249 5mg Pbo tablet bid. Total time in the study will be ~10 weeks.
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Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2007_519, MK0249-018 |
Study First Received: | May 17, 2007 |
Last Updated: | April 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00475735 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Dopamine Uptake Inhibitors Neurotransmitter Agents Attention Deficit and Disruptive Behavior Disorders Methylphenidate Central Nervous System Stimulants Dyskinesias Signs and Symptoms |
Dopamine Attention Deficit Disorder with Hyperactivity Mental Disorders Mental Disorders Diagnosed in Childhood Hyperkinesis Neurologic Manifestations Dopamine Agents |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Nervous System Diseases Attention Deficit and Disruptive Behavior Disorders Methylphenidate Central Nervous System Stimulants Dyskinesias |
Pharmacologic Actions Signs and Symptoms Attention Deficit Disorder with Hyperactivity Mental Disorders Therapeutic Uses Mental Disorders Diagnosed in Childhood Hyperkinesis Neurologic Manifestations Dopamine Agents Central Nervous System Agents |