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

Adult ADHD Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01012375
• Other study ID #: D1950C00007
• Status: Completed
• Phase: Phase 2
• First received: November 11, 2009
• Last updated: August 31, 2011
• Start date: November 2009
• Est. completion date: August 2010

Study information

• Verified date: September 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Adult ADHD

Intervention

Drug:
• AZD1446
10 mg capsule, oral dose
• AZD1446
80 mg capsule, oral dose
• AZD1446
80 mg capsule, oral dose
• Placebo
Matching capsule, oral dose

Locations

Country	Name	City	State
United States	Research Site	Austin	Texas
United States	Research Site	Burlington	Vermont
United States	Research Site	Ft Myers	Florida
United States	Research Site	Los Alamitos	California
United States	Research Site	New York	New York
United States	Research Site	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		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
Secondary	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		Visit 1; Visit 2; Visits 3,4,5; Visit 7; Visits 8, 9, 10; Visit 12; and Visits 13, 14 and 15
Secondary	To assess the safety and tolerability of effects of 2 weeks treatment with AZD1446 compared to placebo.		From enrollment visit to follow up
Secondary	To evaluate the pharmacokinetics (PK) of AZD1446.		Visits 2,3, 4 7, 8, 9 12, 13 and 14 PK will be collected