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



Status:Completed
Conditions:Neurology, Psychiatric
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:18 - 60
Updated:7/16/2013
Start Date:April 2011
End Date:February 2013
Contact:Novartis Pharmaceuticals
Phone:+1(862)778-8300

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


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


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assessments or Patients who meet predefined criteria for treatment failure, were withdrawn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
We found this trial at
14
sites
Dallas, Texas 75216
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Ann Arbor, Michigan 48109
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Bismark, North Dakota 58501
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Blue Bell, Pennsylvania 19422
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Brick, New Jersey 08724
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Brick, NJ
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Chicago, Illinois 60637
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Chicago, IL
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Cincinatti, Ohio 45219
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Fayetteville, Arkansas 72703
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Las Vegas, Nevada 89135
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Las Vegas, NV
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Los Angeles, California 90095
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Los Angeles, CA
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Louisville, Kentucky 40202
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Louisville, KY
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Miami, Florida 33136
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Miami, FL
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Oklahoma City, Oklahoma 73104
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Oklahoma City, OK
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Spokane, Washington 99202
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Spokane, WA
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