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 |
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assessments or Patients who meet predefined criteria for treatment failure, were withdrawn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
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