A Study of Paliperidone Palmitate 3 Month Formulation for the Treatment of Patients With Schizophrenia

PHASE3CompletedINTERVENTIONAL
Enrollment

509

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

April 30, 2014

Study Completion Date

April 30, 2014

Conditions
Schizophrenia
Interventions
DRUG

PP3M 175 mg eq.

Type= exact number, unit= mg eq., number= 175, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.

DRUG

PP3M 263 mg eq.

Type= exact number, unit= mg eq., number= 263, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.

DRUG

PP3M 350 mg eq.

Type= exact number, unit= mg eq., number= 350, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.

DRUG

PP3M 525 mg eq.

Type= exact number, unit= mg eq., number= 525, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.

DRUG

Placebo (20% Intralipid emulsion)

Form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.

Trial Locations (53)

Unknown

Little Rock

San Fran Cisco

Washington D.C.

Lauderhill

Chicago

Hoffman Estates

Topeka

Baltimore

Flowood

Marlton

Cedarhurst

Oklahoma City

Austin

Dallas

Salt Lake City

Barranquilla

Bogotá

Medellín

Pereira

Johor Bahru

Kuala Lumpur

Tanjong Rambutan

Guadajalara

Mexico City

Monterrey

San Luis Potosí City

Zapopan

Arad

Craiova

Iași

Sibiu

Tg Mures

Deajun

Gyeongsangnam-Do

Incheon

Seongnam

Diyarbakır

Sakarya

Donetsk

Evpatoriya

Hlevakha

Ivano-Frankivsk

Kerch

Kharkiv

Kherson

Kiev

Lviv

Odesa

Poltava

Smila

Ternopil

Uzhhorod

Vinnitsa

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT01529515 - A Study of Paliperidone Palmitate 3 Month Formulation for the Treatment of Patients With Schizophrenia | Biotech Hunter | Biotech Hunter