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

NCT ID: NCT01012375

Last Updated: 2011-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Adult ADHD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

AZD1446 tid

Group Type EXPERIMENTAL

AZD1446

Intervention Type DRUG

10 mg capsule, oral dose

2

AZD1446 tid

Group Type EXPERIMENTAL

AZD1446

Intervention Type DRUG

80 mg capsule, oral dose

3

AZD1446 qd

Group Type EXPERIMENTAL

AZD1446

Intervention Type DRUG

80 mg capsule, oral dose

4

Matching placebo capsule

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching capsule, oral dose

Interventions

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AZD1446

10 mg capsule, oral dose

Intervention Type DRUG

AZD1446

80 mg capsule, oral dose

Intervention Type DRUG

AZD1446

80 mg capsule, oral dose

Intervention Type DRUG

Placebo

Matching capsule, oral dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul A Newhouse, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Science Research Unit, Department of Psychiatry, University of Vermont,1 South Prospect Street, Burlington, VT 05401

Bjorn Paulsson, MD

Role: STUDY_DIRECTOR

AstraZeneca Pharmaceuticals, Kvarnbergagatan 12S-151 85, Sodertalje, Sweden

Locations

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Research Site

Los Alamitos, California, United States

Site Status

Research Site

Fort Myers, Florida, United States

Site Status

Research Site

New York, New York, United States

Site Status

Research Site

Austin, Texas, United States

Site Status

Research Site

Burlington, Vermont, United States

Site Status

Research Site

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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D1950C00007

Identifier Type: -

Identifier Source: org_study_id

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