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Sponsors and Collaborators: |
AstraZeneca Targacept Inc. |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00683462 |
A 3-way cross-over trial of two weeks of treatment with three drug conditions. AZD3480 will be given in doses of (A) 5mg/day, (B) 50 mg/day and (C) placebo to 24 non-smoking adults with DSM-IV confirmed ADHD. Three week washout between each treatment period. CYP2D6 genotyping will be completed at screening and slow metabolisers will be excluded from participation in this study. Cognitive, ADHD symptom, safety and pharmacokinetic (PK) assessments will be made during each treatment period. Safety and tolerability assessments will be a major component of the trial and all serious adverse events (SAE) will be immediately (within 24 hours) reported to both Targacept and to AstraZenca.
Condition | Intervention | Phase |
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ADHD |
Drug: Placebo Drug: AZD3480 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Efficacy Study |
Official Title: | An Exploratory Trial of AZD3480 (TC-1734) for the Treatment of Adult Attention-Deficit/Hyperactivity Disorder (ADHD) |
Estimated Enrollment: | 24 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | April 2009 |
Arms | Assigned Interventions |
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1: Placebo Comparator | Drug: Placebo |
2: Experimental |
Drug: AZD3480
Capsules 5 mg/day (once a day) for 2 weeks
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3: Experimental |
Drug: AZD3480
Capsules 50 mg/day (once a day) for 2 weeks
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: David Hosford, MD | +1 919 480-2137 | david.hosford@targacept.com |
United States, Vermont | |
Research Site | Recruiting |
Burlington, Vermont, United States |
Responsible Party: | AstraZeneca R&D, Södertälje ( Hans-Göran Hårdemark, MD, PhD, Medical Science Director AZD3480 ) |
Study ID Numbers: | TC-1734-226-CRD-005 |
Study First Received: | May 21, 2008 |
Last Updated: | May 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00683462 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Attention Deficit Disorder with Hyperactivity Mental Disorders Mental Disorders Diagnosed in Childhood Attention Deficit and Disruptive Behavior Disorders Hyperkinesis |
Attention Deficit Disorder with Hyperactivity Mental Disorders Mental Disorders Diagnosed in Childhood Attention Deficit and Disruptive Behavior Disorders |