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Sponsored by: |
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. |
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Information provided by: | McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. |
ClinicalTrials.gov Identifier: | NCT00326391 |
The purpose of this study is to evaluate the effectiveness and safety of methylphenidate HCl extended-release tablets at five dose levels compared to placebo in adults with Attention Deficit Hyperactivity Disorder (ADHD)
Condition | Intervention | Phase |
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Attention Deficit Disorder With Hyperactivity |
Drug: methylphenidate hydrochloride extended-release tablets |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Placebo-Controlled, Double-Blind, Parallel-Group, Dose-Titration Study to Evaluate the Efficacy and Safety of CONCERTA (Methylphenidate HCl) Extended-Release Tablets in Adults With Attention Deficit Hyperactivity Disorder at Doses of 36 mg, 54 mg, 72 mg, 90 mg, or 108 mg Per Day. |
Estimated Enrollment: | 208 |
Study Start Date: | April 2006 |
Study Completion Date: | December 2006 |
This is a randomized (patients are assigned different treatments based on chance), placebo-controlled , double-blind (neither the patient nor the physician knows whether drug or placebo is being taken), parallel-group, dose-titration, multicenter study to determine the effectiveness and safety of five doses of methylphenidate HCl extended-release tablets, 36 mg, 54 mg, 72 mg (two 36 mg tablets), 90 mg (one 36 mg tablet plus one 54 mg tablet), or 108 mg (two 54 mg tablets) administered orally once per day in adults with Attention Deficit Hyperactivity Disorder. Patients will be randomized to receive either placebo or methylphenidate HCl extended-release tablets for seven weeks. Patients assigned to methylphenidate HCl extended-release tablets will start treatment with 36 mg and continue to receive incremental increases of 18 mg of methylphenidate HCl extended-release tablets every seven days (+/-2 days) until an individualized dose is achieved. The individualized dose is achieved when Adult ADHD Investigator Symptom Rating Scale (AISRS) decreases by 30% and a Clinical Global Impression - Improvement (CGI-I) score is 1 or 2, or titration to the maximum dose of 108 mg is achieved. If a limiting adverse event occurs, the dose will be titrated downward by 18 mg. This dose is then the patient's individualized dose. Once an individualized dose has been achieved, patients will remain on that dose for the duration of the titration period and for the two weeks prior to Final Visit/2-Week Efficacy Assessment Visit. Patients assigned to placebo will follow the same dosing schedule and procedures as the patients randomized to methylphenidate HCl tablets. Safety assessments include monitoring adverse events, blood pressure, pulse, weight, and electrocardiograms (ECG) throughout the study. The primary hypothesis is that methylphenidate HCL extended-release tablets at an individualized dose will be superior to placebo with respect to improvement in the primary efficacy endpoint defined bychange from baseline in the Adult ADHD Investigator Symptom Rating Scale.
Patients will initiate methylphenidate HCl extended-release tablets with 36 mg and continue to receive increases in 18 mg increments for 7 days until an individualized dose or maximum dose of 108 mg is achieved. Patients will remain on this dose for the duration of the titration period and for 2 weeks prior to Final Visit/2 Week Efficacy Assessment; a maximum of 51 days. Patients receiving placebo will follow the same dosing schedule/procedures as patients receiving methylphenidate HCL tablets
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | McNeil Consumer & Specialty Pharmaceuticals Clinical Trial | McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. |
Study ID Numbers: | CR011560 |
Study First Received: | May 12, 2006 |
Last Updated: | March 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00326391 |
Health Authority: | United States: Food and Drug Administration |
Attention Deficit Disorder with Hyperactivity, ADHD,
Attention Deficit Disorder Adult |
Signs and Symptoms Dopamine Attention Deficit Disorder with Hyperactivity Mental Disorders Mental Disorders Diagnosed in Childhood |
Methylphenidate Neurologic Manifestations Attention Deficit and Disruptive Behavior Disorders Hyperkinesis Dyskinesias |
Dopamine Uptake Inhibitors Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Disease Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs |
Central Nervous System Stimulants Pharmacologic Actions Pathologic Processes Therapeutic Uses Dopamine Agents Central Nervous System Agents |