- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01012375
Study to Investigate the Efficacy and Tolerability of AZD1446 in Adult ADHD Patients.
August 31, 2011 updated by: AstraZeneca
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
The purpose of this study is to determine whether 2 weeks of treatment with AZD1446 compared to placebo improves ADHD symptoms and is well tolerated.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
135
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Alamitos, California, United States
- Research Site
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Florida
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Ft Myers, Florida, United States
- Research Site
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New York
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New York, New York, United States
- Research Site
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Texas
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Austin, Texas, United States
- Research Site
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Vermont
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Burlington, Vermont, United States
- Research Site
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Washington
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Seattle, Washington, United States
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- A confirmed diagnosis of ADHD
- Patient understands and is willing to comply with all study requirements
- Adults between the ages of 18-65 inclusive
Exclusion Criteria:
- Current psychiatric disorder other than ADHD
- Previous randomization into this study
- Women with a positive pregnancy test
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
AZD1446 tid
|
10 mg capsule, oral dose
80 mg capsule, oral dose
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EXPERIMENTAL: 2
AZD1446 tid
|
10 mg capsule, oral dose
80 mg capsule, oral dose
|
EXPERIMENTAL: 3
AZD1446 qd
|
10 mg capsule, oral dose
80 mg capsule, oral dose
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PLACEBO_COMPARATOR: 4
Matching placebo capsule
|
Matching capsule, oral dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AZD1446 compared to placebo, improves ADHD core symptoms in adult non-users and users of nicotine products after 2 weeks of treatment as measured by the Conners' Adult ADHD Rating Scale-Investigator Rated (CAARS-INV) Total ADHD Symptoms score (18 item)
Time Frame: The CAARS-INV will be administered once at each of the following visits: Visit 1; Visit 2; Visits 3,4,5; Visit 7; Visits 8, 9, 10; Visit 12; and Visits 13, 14 and 15
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The CAARS-INV will be administered once at each of the following visits: Visit 1; Visit 2; Visits 3,4,5; Visit 7; Visits 8, 9, 10; Visit 12; and Visits 13, 14 and 15
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the effect of AZD1446 treatment compared to placebo on ADHD symptoms as derived from the 30 item Conners' Adult ADHD Rating Scale-Investigator Rated (CAARS-INV) scoring
Time Frame: Visit 1; Visit 2; Visits 3,4,5; Visit 7; Visits 8, 9, 10; Visit 12; and Visits 13, 14 and 15
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Visit 1; Visit 2; Visits 3,4,5; Visit 7; Visits 8, 9, 10; Visit 12; and Visits 13, 14 and 15
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To assess the safety and tolerability of effects of 2 weeks treatment with AZD1446 compared to placebo.
Time Frame: From enrollment visit to follow up
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From enrollment visit to follow up
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To evaluate the pharmacokinetics (PK) of AZD1446.
Time Frame: Visits 2,3, 4 7, 8, 9 12, 13 and 14 PK will be collected
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Visits 2,3, 4 7, 8, 9 12, 13 and 14 PK will be collected
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Paul A Newhouse, MD, Clinical Science Research Unit, Department of Psychiatry, University of Vermont,1 South Prospect Street, Burlington, VT 05401
- Study Director: Bjorn Paulsson, MD, AstraZeneca Pharmaceuticals, Kvarnbergagatan 12S-151 85, Sodertalje, Sweden
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (ACTUAL)
August 1, 2010
Study Completion (ACTUAL)
August 1, 2010
Study Registration Dates
First Submitted
November 11, 2009
First Submitted That Met QC Criteria
November 12, 2009
First Posted (ESTIMATE)
November 13, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
September 2, 2011
Last Update Submitted That Met QC Criteria
August 31, 2011
Last Verified
September 1, 2010
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- D1950C00007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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