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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Attention Deficit/Hyperactivity Disorder

Intervention: Ritalin LA (methylphenidate hydrochloride extended release) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

Summary

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

Clinical Details

Official title: A 6-month, Open-label Extension to a 40-week, Randomized, Double-blind, Placebo-controlled, Multicenter Efficacy and Safety Study of Methylphenidate Hydrochloride Extended Release in the Treatment of Adult Patients With Childhood-onset ADHD

Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Participants With Adverse Events, Serious Adverse Events and Deaths.

Secondary outcome:

Change From Extension Baseline (Week 40) to End of Study (Week 66) in on DSM-IV Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) Total Score.

Change From Extension Baseline (Week 40) to End of Study (Week 66) on Sheehan Disability Scale (SDS) Total Score

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. 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and Week 40 (End of Study) assessments or Patients who meet predefined criteria for treatment failure, were withdrawn from the core study, and have completed core-study week 40 assessments (Premature Discontinuation Visit) Exclusion Criteria: 1. 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. 2. Patients who during the core study developed cardiovascular disorders. 3. Pregnant women. 4. Patients who developed seizures during the core study. 5. Diagnosis of glaucoma, hyperthyroidism, pheochromocytoma. 6. Diagnosis or family history of Tourette's syndrome. 7. 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

Locations and Contacts

Novartis Investigative Site, Brugge 8310, Belgium

Novartis Investigative Site, Heusden-Zolder 3550, Belgium

Novartis Investigative Site, Kessel-Lo 3010, Belgium

Novartis Investigative Site, Mechelen 2800, Belgium

Novartis Investigative Site, Uccle 1180, Belgium

Novartis Investigative Site, Antioquia 0000, Colombia

Novartis Investigative Site, Antioquia, Colombia

Novartis Investigative Site, Århus C 8000, Denmark

Novartis Investigative Site, Bamberg 96047, Germany

Novartis Investigative Site, Berlin 10629, Germany

Novartis Investigative Site, Berlin 12203, Germany

Novartis Investigative Site, Dresden 01129, Germany

Novartis Investigative Site, Freiburg 79104, Germany

Novartis Investigative Site, Freiburg 79106, Germany

Novartis Investigative Site, Hamburg 20259, Germany

Novartis Investigative Site, Homburg 66421, Germany

Novartis Investigative Site, Landau 76829, Germany

Novartis Investigative Site, Leipzig 04157, Germany

Novartis Investigative Site, Limburg 65549, Germany

Novartis Investigative Site, Ludwigsburg 71636, Germany

Novartis Investigative Site, Mainz 55131, Germany

Novartis Investigative Site, Mannheim 68159, Germany

Novartis Investigative Site, München 80333, Germany

Novartis Investigative Site, Naumburg 06618, Germany

Novartis Investigative Site, Nürnberg 90419, Germany

Novartis Investigative Site, Siegen 57076, Germany

Novartis Investigative Site, Ulm 89081, Germany

Novartis Investigative Site, Westerstede/Oldenburg 26655, Germany

Novartis Investigative Site, Wolfsburg 38444, Germany

Novartis Investigative Site, Würzburg 97070, Germany

Novartis Investigative Site, Luleå 972 35, Sweden

Novartis Investigative Site, Malmö 211 53, Sweden

Novartis Investigative Site, Little Rock, Arkansas 72205, United States

Novartis Investigative Site, Beverly Hills, California 90210, United States

Novartis Investigative Site, Spring Valley, California 91978-1522, United States

Novartis Investigative Site, Bradenton, Florida 34208, United States

Novartis Investigative Site, Orlando, Florida 32806, United States

Novartis Investigative Site, West Plam Beach, Florida 33407, United States

Novartis Investigative Site, Libertyville, Illinois 60048, United States

Novartis Investigative Site, Owensboro, Kentucky 42301, United States

Novartis Investigative Site, Las Vegas, Nevada 89128, United States

Novartis Investigative Site, Las Vegas, Nevada 89119, United States

Novartis Investigative Site, Fargo, North Dakota 58103, United States

Novartis Investigative Site, Columbus, Ohio 43210, United States

Novartis Investigative Site, Philadelphia, Pennsylvania 19149, United States

Novartis Investigative Site, Houston, Texas 77007, United States

Novartis Investigative Site, Bellevue, Washington 98004, United States

Novartis Investigative Site, Seattle, Washington 98104, United States

Additional Information

Starting date: April 2011
Last updated: November 4, 2014

Page last updated: August 23, 2015

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