Efficacy and Safety Study of Methylphenidate Hydrochloride Extended Release in Adults With Childhood-onset Attention Deficit/Hyperactivity Disorder (ADHD)

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate efficacy and safety of methylphenidate hydrochloride extended release compared to placebo in adult patients with childhood-onset attention deficit/hyperactivity disorder (ADHD).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Methylphenidate

Criteria

Inclusion criteria:

1. Diagnosis of attention deficit/hyperactivity disorder (ADHD) which started in childhood

2. Female patients of childbearing potential must be practicing an acceptable method of contraception.

Exclusion criteria:

1. Patients with body mass index (BMI) less than 18.5 kg/m2 or more than 35 kg/m2

2. History of alcohol or substance abuse within the last six months.

3. History of seizures or use of anticonvulsant medication.

4. Any psychiatric condition that requires medication or may interfere with study participation.

5. Pre-existing cardiovascular disorders including severe hypertension, heart failure, myocardial infraction, etc.

6. Significant respiratory, hepatic, gastrointestinal, renal, hematological or oncologic disorder

7. Diagnosis of glaucoma, hyperthyroidism, pheochromocytoma

8. Diagnosis or family history of Tourette's syndrome

9. Pre-existing cerebrovascular disorders such as cerebral aneurysm, vascular abnormalities including vasculitis or stroke

Other protocol-defined inclusion/exclusion criteria may apply