Open Label, Multicentre Extension Study of Protocol 42603ATT3002 to Evaluate Safety of Prolonged Release OROS Methlyphenidate in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

PHASE3CompletedINTERVENTIONAL
Enrollment

155

Participants

Timeline

Start Date

January 31, 2006

Primary Completion Date

July 31, 2008

Study Completion Date

July 31, 2008

Conditions
Attention Deficit Disorder With Hyperactivity
Interventions
DRUG

double blind placebo

matching placebo tablets once daily for 4 weeks

DRUG

double blind PR OROS methylphenidate

18, 36, 54,72 or 90 mg/day once daily for 4 weeks

DRUG

open label PR OROS methylphenidate

Flexible dosage MPH (18 to 90 mg/day) for 72 weeks (108 weeks for Germany)

Trial Locations (21)

Unknown

Paris

Ahrensburg

Aschaffenburg

Berlin

Cologne

Essen

Freiburg I. Br.

Homburg

Mannheim

Ottobrunn bei München

Saarbrücken

Würzburg

Nijmegen

The Hague

Drammen

Ottestad

Cascais

Porto

Barcelona

Basel Bs

Zurich

Sponsors
All Listed Sponsors
lead

Janssen-Cilag International NV

INDUSTRY

NCT00307684 - Open Label, Multicentre Extension Study of Protocol 42603ATT3002 to Evaluate Safety of Prolonged Release OROS Methlyphenidate in Adults With Attention Deficit Hyperactivity Disorder (ADHD) | Biotech Hunter | Biotech Hunter