Study to Investigate the Efficacy and Tolerability of AZD1446 in Adult ADHD Patients.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01012375
First received: November 11, 2009
Last updated: August 31, 2011
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Adult ADHD
Drug: AZD1446
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To evaluate the pharmacokinetics (PK) of AZD1446. [ Time Frame: Visits 2,3, 4 7, 8, 9 12, 13 and 14 PK will be collected ] [ Designated as safety issue: No ]

Enrollment: 135
Study Start Date: November 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AZD1446 tid
Drug: AZD1446
10 mg capsule, oral dose
Experimental: 2
AZD1446 tid
Drug: AZD1446
80 mg capsule, oral dose
Experimental: 3
AZD1446 qd
Drug: AZD1446
80 mg capsule, oral dose
Placebo Comparator: 4
Matching placebo capsule
Drug: Placebo
Matching capsule, oral dose

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01012375

Locations
United States, California
Research Site
Los Alamitos, California, United States
United States, Florida
Research Site
Ft Myers, Florida, United States
United States, New York
Research Site
New York, New York, United States
United States, Texas
Research Site
Austin, Texas, United States
United States, Vermont
Research Site
Burlington, Vermont, United States
United States, Washington
Research Site
Seattle, Washington, United States
Sponsors and Collaborators
AstraZeneca
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
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01012375     History of Changes
Other Study ID Numbers: D1950C00007
Study First Received: November 11, 2009
Last Updated: August 31, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Adult ADHD

ClinicalTrials.gov processed this record on July 26, 2014