Open-label Extension Evaluating Methylphenidate Hydrochloride Extended Release in Adults With Attention Deficit/Hyperactivity Disorder

Completed · Phase 3

Conditions studied: Attention Deficit/Hyperactivity Disorder

In brief

This study will evaluate the long-term safety of methylphenidate hydrochloride extended release in adults with attention deficit/hyperactivity disorder

Key facts

Study ID

NCT01338818

Run by

Novartis Pharmaceuticals

People needed

299

Starts

2011-04-01

Expected to finish

2013-02-01

Last updated by the study team

2014-11-24

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Completion of the 40-week core study CRIT124D2302 and Week 40 (End of Study) assessments or Patients who meet predefined criteria for treatment failure, were withdrawn from the core study, and have completed core-study week 40 assessments (Premature Discontinuation Visit)

You may not qualify if…

• Patients who, during the core study, developed any psychiatric condition that requires treatment with medication or that may interfere with study participation and /or study assessments.
• Patients who during the core study developed cardiovascular disorders.
• Pregnant women.
• Patients who developed seizures during the core study.
• Diagnosis of glaucoma, hyperthyroidism, pheochromocytoma.
• Diagnosis or family history of Tourette's syndrome.
• Patients who during the core study developed cerebrovascular disorders such as cerebral aneurysm, vascular abnormalities including vasculitis and stroke
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Novartis Investigative Site — Little Rock, Arkansas, United States
• Novartis Investigative Site — Beverly Hills, California, United States
• Novartis Investigative Site — Spring Valley, California, United States
• Novartis Investigative Site — Bradenton, Florida, United States
• Novartis Investigative Site — Orlando, Florida, United States
• Novartis Investigative Site — West Plam Beach, Florida, United States
• Novartis Investigative Site — Libertyville, Illinois, United States
• Novartis Investigative Site — Owensboro, Kentucky, United States
• Novartis Investigative Site — Las Vegas, Nevada, United States
• Novartis Investigative Site — Las Vegas, Nevada, United States
• Novartis Investigative Site — Fargo, North Dakota, United States
• Novartis Investigative Site — Columbus, Ohio, United States
• Novartis Investigative Site — Philadelphia, Pennsylvania, United States
• Novartis Investigative Site — Houston, Texas, United States
• Novartis Investigative Site — Bellevue, Washington, United States
• Novartis Investigative Site — Seattle, Washington, United States
• Novartis Investigative Site — Bruges, Belgium, Belgium
• Novartis Investigative Site — Heusden-Zolder, Belgium, Belgium
• Novartis Investigative Site — Uccle, Belgium, Belgium
• Novartis Investigative Site — Kessel-Lo, Belgium
• Novartis Investigative Site — Mechelen, Belgium
• Novartis Investigative Site — Santa Fe de Antioquia, Antioquia, Colombia
• Novartis Investigative Site — Antioquia, Colombia
• Novartis Investigative Site — Århus C, Denmark
• Novartis Investigative Site — Bamberg, Germany, Germany

Full record on ClinicalTrials.gov

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