Study to investigate the efficacy and tolerability of AZD1446 in Adult ADHD patients.
Study identifier:D1950C00007
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase IIa, Multi-center, Randomized, Double-blind, Placebo-controlled, Cross-Over Study to Assess the Efficacy, Safety ,tolerability and Pharmacokinetics of Three Oral AZD1446 Dose Regimens and Placebo During 2 weeks of Treatment in Adult Non-Users and users of Nicotine Containing Products
Medical condition
Adult ADHD
Phase
Phase 2
Healthy volunteers
No
Study drug
AZD1446,, AZD1446, qd, AZD1446, tid, Placebo
Sex
All
Actual Enrollment
79
Study type
Interventional
Age
18 Years - 65 Years
Date
Study Start Date: 01 Nov 2009
Primary Completion Date: 01 Aug 2010
Study Completion Date: 01 Aug 2010
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Jul 2014 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Experimental: Sequence 1 Nicotine non-user: First 10 mg tid, then 80 mg qd, then Placebo | Drug: AZD1446, 10 mg capsule, oral dose, tid (three times per day) Drug: AZD1446, qd 80 mg capsule, oral dose qd (once per day) Drug: Placebo Matching capsule, oral dose |
| Experimental: Sequence 2 Nicotine non-user: First 10 mg tid, then 80 mg tid, then Placebo | Drug: AZD1446, 10 mg capsule, oral dose, tid (three times per day) Drug: AZD1446, tid 80 mg capsule, oral dose tid (three times per day) Drug: Placebo Matching capsule, oral dose |
| Experimental: Sequence 3 Nicotine non-user: First 10 mg tid, then Placebo, then 80 mg qd | Drug: AZD1446, 10 mg capsule, oral dose, tid (three times per day) Drug: AZD1446, qd 80 mg capsule, oral dose qd (once per day) Drug: Placebo Matching capsule, oral dose |
| Experimental: Sequence 4 Nicotine non-user: First 10 mg tid, then Placebo, then 80 mg tid | Drug: AZD1446, 10 mg capsule, oral dose, tid (three times per day) Drug: AZD1446, tid 80 mg capsule, oral dose tid (three times per day) Drug: Placebo Matching capsule, oral dose |
| Experimental: Sequence 5 Nicotine non-user: First 80 mg qd, then 10 mg tid, then Placebo | Drug: AZD1446, 10 mg capsule, oral dose, tid (three times per day) Drug: AZD1446, qd 80 mg capsule, oral dose qd (once per day) Drug: Placebo Matching capsule, oral dose |
| Experimental: Sequence 6 Nicotine non-user: First 80 mg qd, then 80 mg tid, then Placebo | Drug: AZD1446, qd 80 mg capsule, oral dose qd (once per day) Drug: AZD1446, tid 80 mg capsule, oral dose tid (three times per day) Drug: Placebo Matching capsule, oral dose |
| Experimental: Sequence 7 Nicotine non-user: First 80 mg qd, then Placebo, then 10 mg tid | Drug: AZD1446, 10 mg capsule, oral dose, tid (three times per day) Drug: AZD1446, qd 80 mg capsule, oral dose qd (once per day) Drug: Placebo Matching capsule, oral dose |
| Experimental: Sequence 8 Nicotine non-user: First 80 mg qd, then Placebo, then 80 mg tid | Drug: AZD1446, qd 80 mg capsule, oral dose qd (once per day) Drug: AZD1446, tid 80 mg capsule, oral dose tid (three times per day) Drug: Placebo Matching capsule, oral dose |
| Experimental: Sequence 9 Nicotine non-user: First 80 mg tid, then 10 mg tid, then Placebo | Drug: AZD1446, 10 mg capsule, oral dose, tid (three times per day) Drug: AZD1446, tid 80 mg capsule, oral dose tid (three times per day) Drug: Placebo Matching capsule, oral dose |
| Experimental: Sequence 10 Nicotine non-user: First 80 mg tid, then 80 mg qd, then Placebo | Drug: AZD1446, qd 80 mg capsule, oral dose qd (once per day) Drug: AZD1446, tid 80 mg capsule, oral dose tid (three times per day) Drug: Placebo Matching capsule, oral dose |
| Experimental: Sequence 11 Nicotine non-user: First 80 mg tid, then Placebo, then 10 mg tid | Drug: AZD1446, 10 mg capsule, oral dose, tid (three times per day) Drug: AZD1446, tid 80 mg capsule, oral dose tid (three times per day) Drug: Placebo Matching capsule, oral dose |
| Experimental: Sequence 12 Nicotine non-user: First 80 mg tid, then Placebo, then 80 mg qd | Drug: AZD1446, qd 80 mg capsule, oral dose qd (once per day) Drug: AZD1446, tid 80 mg capsule, oral dose tid (three times per day) Drug: Placebo Matching capsule, oral dose |
| Experimental: Sequence 13 Nicotine non-user: First Placebo, then 10 mg tid, then 80 mg qd | Drug: AZD1446, 10 mg capsule, oral dose, tid (three times per day) Drug: AZD1446, qd 80 mg capsule, oral dose qd (once per day) Drug: Placebo Matching capsule, oral dose |
| Experimental: Sequence 14 Nicotine non-user: First Placebo, then 10 mg tid, then 80 mg tid | Drug: AZD1446, 10 mg capsule, oral dose, tid (three times per day) Drug: AZD1446, tid 80 mg capsule, oral dose tid (three times per day) Drug: Placebo Matching capsule, oral dose |
| Experimental: Sequence 15 Nicotine non-user: First Placebo, then 80 mg qd, then 10 mg tid | Drug: AZD1446, 10 mg capsule, oral dose, tid (three times per day) Drug: AZD1446, qd 80 mg capsule, oral dose qd (once per day) Drug: Placebo Matching capsule, oral dose |
| Experimental: Sequence 16 Nicotine non-user: First Placebo, then 80 mg qd, then 80 mg tid | Drug: AZD1446, qd 80 mg capsule, oral dose qd (once per day) Drug: AZD1446, tid 80 mg capsule, oral dose tid (three times per day) Drug: Placebo Matching capsule, oral dose |
| Experimental: Sequence 17 Nicotine non-user: First Placebo, then 80 mg tid, then 10 mg tid | Drug: AZD1446, 10 mg capsule, oral dose, tid (three times per day) Drug: AZD1446, tid 80 mg capsule, oral dose tid (three times per day) Drug: Placebo Matching capsule, oral dose |
| Experimental: Sequence 18 Nicotine non-user: First Placebo, then 80 mg tid, then 80 mg qd | Drug: AZD1446, qd 80 mg capsule, oral dose qd (once per day) Drug: AZD1446, tid 80 mg capsule, oral dose tid (three times per day) Drug: Placebo Matching capsule, oral dose |
| Experimental: Sequence 19 Nicotine user: First 80 mg qd, then 80 mg tid, then Placebo | Drug: AZD1446, qd 80 mg capsule, oral dose qd (once per day) Drug: AZD1446, tid 80 mg capsule, oral dose tid (three times per day) Drug: Placebo Matching capsule, oral dose |
| Experimental: Sequence 20 Nicotine user: First 80 mg qd, then Placebo, then 10 mg tid | Drug: AZD1446, 10 mg capsule, oral dose, tid (three times per day) Drug: AZD1446, qd 80 mg capsule, oral dose qd (once per day) Drug: Placebo Matching capsule, oral dose |
| Experimental: Sequence 21 Nicotine user: First 80 mg qd, then Placebo, then 80 mg tid | Drug: AZD1446, qd 80 mg capsule, oral dose qd (once per day) Drug: AZD1446, tid 80 mg capsule, oral dose tid (three times per day) Drug: Placebo Matching capsule, oral dose |
| Experimental: Sequence 22 Nicotine user: First 80 mg tid, then 80 mg qd, then Placebo | Drug: AZD1446, qd 80 mg capsule, oral dose qd (once per day) Drug: AZD1446, tid 80 mg capsule, oral dose tid (three times per day) Drug: Placebo Matching capsule, oral dose |
| Experimental: Sequence 23 Nicotine user: First 80 mg tid, then Placebo, then 80 mg qd | Drug: AZD1446, qd 80 mg capsule, oral dose qd (once per day) Drug: AZD1446, tid 80 mg capsule, oral dose tid (three times per day) Drug: Placebo Matching capsule, oral dose |
| Experimental: Sequence 24 Nicotine user: First Placebo, then 80 mg qd, then 80 mg tid | Drug: AZD1446, qd 80 mg capsule, oral dose qd (once per day) Drug: AZD1446, tid 80 mg capsule, oral dose tid (three times per day) Drug: Placebo Matching capsule, oral dose |
| Experimental: Sequence 25 Nicotine user: First Placebo, then 80 mg tid, then 80 mg qd | Drug: AZD1446, qd 80 mg capsule, oral dose qd (once per day) Drug: AZD1446, tid 80 mg capsule, oral dose tid (three times per day) Drug: Placebo Matching capsule, oral dose |
Contacts
Investigators
Principal Investigator
Paul A Newhouse
Clinical Science Research Unit, Department of Psychiatry, University of Vermont,1 South Prospect Street, Burlington, VT 05401
