Clinical trial NCT00301236: Efficacy, Tolerability and Safety of Dexmethylphenidate HCl Extended-Release Capsules in Children With Attention-Deficit/Hyperactivity Disorder
Official title: A 5-Week Treatment, Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Fixed-Dose Study of the Efficacy, Tolerability and Safety of Dexmethylphenidate HCl Extended-Release Capsules Administered Once Daily in Pediatric Children With Attention-Deficit/Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: ADHD, ADD
Keywords: ADHD, children, CADS-T, Dexmethylphenidate-HCl, extended release
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-03-10
Enrollment: 252
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine which dosages of dexmethylphenidate HCl extended-release capsules may represent effective treatment for ADHD in children 6-12 years of age.

Detailed description: The purpose of this study is to determine which dosages of dexmethylphenidate HCl extended-release capsules may represent effective treatment for ADHD in children 6-12 years of age.

Eligibility criteria: Inclusion Criteria:

* Children 6 - 12 with a diagnosis of ADHD of any type , Same teacher who is willing to complete the assessment during the school term

Exclusion Criteria:

* Previous cardiac problems of the patient or the parents or current cardiac findings of the patient; Relevant medical condition other than ADHD; ADHD medication within a specified timeperiod prior to study start; Pregnancy or nursing; Positive drug screen

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Assessment of the symptoms by the patient's teacher after 5 weeks of treatment.
Secondary outcomes:
measure: Assessment of the symptoms by the patient's parent after five weeks of treatment.
measure: Change in severity of the illness assessed by the physician after 5 weeks of treatment
measure: Improvement of the illness assessed by the physician after 5 weeks of treatment
measure: Safety and tolerability of 5 week's treatment with dexmethylphenidate HCl extended-release capsules in children with Attention-Deficit/Hyperactivity Disorder by assessing the frequency of adverse findings
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Novartis Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Novartis Investigational Site
state: Arkansas
city: Los Angeles
country: United States
facility: Novartis Investigational Site
state: California
city: Boulder
country: United States
facility: Novartis Investigational Site
state: Colorado
city: Maitland
country: United States
facility: Novartis Investigational Site
state: Florida
city: Orlando
country: United States
facility: Novartis Investigational Site
state: Florida
city: Stone Mountain
country: United States
facility: Novartis Investigational Site
state: Georgia
city: Libertyville
country: United States
facility: Novartis Investigational Site
state: Illinois
city: Overland Park
country: United States
facility: Novartis Investigational Site
state: Kansas
city: Prairie Village
country: United States
facility: Novartis Investigational Site
state: Kansas
city: Cambridge
country: United States
facility: Novartis Investigational Site
state: Massachusetts
city: Las Vegas
country: United States
facility: Novartis Investigational Site
state: Nevada
city: Piscataway
country: United States
facility: Novartis Investigational Site
state: New Jersey
city: Toms River
country: United States
facility: Novartis Investigational Site
state: New Jersey
city: New York
country: United States
facility: Novartis Investigational Site
state: New York
city: New York
country: United States
facility: Novartis Investigational Site
state: New York
city: Staten Island
country: United States
facility: Novartis Investigational Site
state: New York
city: Chapel Hill
country: United States
facility: Novartis Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Novartis Investigational Site
state: North Carolina
city: Columbus
country: United States
facility: Novartis Investigational Site
state: Ohio
city: Gresham
country: United States
facility: Novartis Investigational Site
state: Oregon
city: Philadelphia
country: United States
facility: Novartis Investigational Site
state: Pennsylvania
city: Jackson
country: United States
facility: Novartis Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: Novartis Investigational Site
state: Tennessee
city: Houston
country: United States
facility: Novartis Investigational Site
state: Texas
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References: