Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00326300
Status:
COMPLETED
Last Update Posted:
2011-05-24
First Post:
2006-05-12
Brief Title:
A Long-Term Safety Study to Evaluate Methylphenidate HCL Tablets at Multiple Dose Levels in Adults With Attention Deficit Hyperactivity Disorder
Sponsor:
McNeil Consumer Specialty Pharmaceuticals a Division of McNeil-PPC Inc
Organization:
McNeil Consumer Specialty Pharmaceuticals a Division of McNeil-PPC Inc
Study Overview
Official Title:
An Open-Label Dose-Titration Long-Term Safety Study to Evaluate CONCERTA Methylphenidate HCL Extended-release Tablets at Doses of 36 mg 54 mg 72 mg 90 mg and 108 mg Per Day in Adults With Attention Deficit Hyperactivity Disorder
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the long-term safety of methylphenidate HCL extended-release tablets at five dose levels in adults with Attention Deficit Hyperactivity Disorder ADHD
Detailed Description:
This is a multicenter open-label dose-titration long-term study to evaluate the long-term safety of five dose levels 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 and 108 mg two 54 mg tablets per day in adults with ADHD At the baseline visit all patients will initiate treatment with 36 mg of methylphenidate HCL extended-release tablets The dose will be increased in 18 mg increments every seven days -2 days until an individualized dose is achieved An individualized dose is achieved when there is at least a 30 improvement on the ADHD Investigator Symptoms Rating Scale AISRS and a Clinical Global Impression - Improvement CGI-I score of 1 or 2 or until 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 individualized dose Once an individualized dose is achieved patients will remain on that dose for approximately six months or one year as assigned at the time of enrollment Patients will be given a prescription for a one-month supply of drug and a pharmacy card at each visit Safety assessments include monitoring adverse events blood pressure pulse weight and electrocardiograms ECG throughout the study The study hypothesis is that methylphenidate HCL extended-release tablets in doses of 36 mg 54 mg 72 mg 90 mg and 108 mg per day will have an acceptable safety profile for the management of ADHD in adults
Patients will start treatment with 36 mg extended-release tablets of methylphenidate HCL per day The dose will be increased in 18 mg increments every 7 days -2 days until they achieve their individualized dose or reach a maximum dose of 108 mg daily Following the patients titration the patient will remain on the individualized dose for approximately 6 months or one year as determined at the time of enrollment
Patients will start treatment with 36 mg extended-release tablets of methylphenidate HCL per day The dose will be increased in 18 mg increments every 7 days -2 days until they achieve their individualized dose or reach a maximum dose of 108 mg daily Following the patients titration the patient will remain on the individualized dose for approximately 6 months or one year as determined at the time of enrollment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None