A Safety and Pharmacokinetic Study of Paliperidone Palmitate in Patients With Schizophrenia

PHASE1CompletedINTERVENTIONAL
Enrollment

212

Participants

Timeline

Start Date

September 30, 2007

Primary Completion Date

June 30, 2009

Study Completion Date

June 30, 2009

Conditions
Schizophrenia
Interventions
DRUG

Paliperidone palmitate Treatment A

All patients will receive a single IM injection of 150mg eq of study drug on Day 1. Patients who tolerate 150mg eq will receive a 2nd IM injection of 150mg eq on Day 8 followed by 12 IM injections (1 every 4 weeks) of 150mg eq. All other patients will be assigned to Treatment B.

DRUG

Paliperidone palmitate Treatment B

Patients not tolerating Treatment A will receive a single IM injection of study drug 100mg eq at their next scheduled visit followed by injections (1 every 4 weeks) ranging from 50 to 150mg eq

Trial Locations (28)

Unknown

Cerritos

National City

San Diego

Atlanta

Philadelphia

Aalst

Zagreb

Kuala Lumpur

Leszno

Lubliniec

Poznan

Torun

Bratislava

Michalovce

Rimavská Sobota

Gwangju

Incheon

Seoul

Badalona

Barcelona

Madrid

Hualien City

Kaohsiung City

Tainan City

Taipei

Taoyuan District

Bangkok

Chiang Mai

All Listed Sponsors
lead

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

NCT01150448 - A Safety and Pharmacokinetic Study of Paliperidone Palmitate in Patients With Schizophrenia | Biotech Hunter | Biotech Hunter