Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Patients With Schizophrenia

PHASE3CompletedINTERVENTIONAL
Enrollment

1,429

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

February 28, 2015

Study Completion Date

March 31, 2015

Conditions
Schizophrenia
Interventions
DRUG

PP3M 175 mg eq.

Type= exact number, unit= mg eq., number= 175, form= injection, route= intramuscular use. One injection every third month for 48 weeks.

DRUG

PP3M 263 mg eq.

Type= exact number, unit= mg eq., number= 263, form= injection, route= intramuscular use. One injection every third month for 48 weeks.

DRUG

PP3M 350 mg eq.

Type= exact number, unit= mg eq., number= 350, form= injection, route= intramuscular use. One injection every third month for 48 weeks.

DRUG

PP3M 525 mg eq.

Type= exact number, unit= mg eq., number= 525, form= injection, route= intramuscular use. One injection every third month for 48 weeks.

DRUG

Placebo (20% Intralipid)

Form= injection, route= intramuscular use. One injection monthly when not receiving active medication for 48 weeks.

DRUG

PP1M 50 mg eq.

Type= exact number, unit= mg eq., number= 50, form= injection, route= intramuscular use. One injection every month for 48 weeks.

DRUG

PP1M 75 mg eq.

Type= exact number, unit= mg eq., number= 75, form= injection, route= intramuscular use. One injection every month for 48 weeks.

DRUG

PP1M 100 mg eq.

Type= exact number, unit= mg eq., number= 100, form= injection, route= intramuscular use. One injection every month for 48 weeks.

DRUG

PP1M 150 mg eq.

Type= exact number, unit= mg eq., number= 150, form= injection, route= intramuscular use. One injection every month for 48 weeks.

Trial Locations (174)

Unknown

Little Rock

Glendale

Long Beach

Oakland

Oceanside

Orange

San Diego

New Britain

Bradenton

Kissimmee

Tampa

Wichita

East Lansing

St Louis

Las Vegas

Jamaica

Durham

Canton

Oklahoma City

Philadelphia

Charleston

Memphis

Austin

Bothell

Buenos Aires

Córdoba

Rosario

Elizabeth Vale

Frankston

Innsbruck

Assebroek

Bertrix

Dave

Heusden

Jette

Marchienne-au-Pont

Sint-Denijs-Westrem

Rio de Janeiro

Burgas

Kazanlak

Radnevo

Sofia

Calgary

Halifax

Montreal

Burlington

Baoding

Beijing

Changsha

Guangdong

Guangzhou

Hangzhou

Kunming

Shanghai

Tianjin

Wuhan

Xi'an

Brno

Hořovice

Liberec

Prague

Přerov

Clermont-Ferrand

Dole

Montpellier

Toulon

Bochum

Gelsenkirchen

Hamburg

Heidelberg

München

Arta

Athens

Katerini

Balassagyarmat

Budapest

Gyõr

Kalocsa

Sopron

Aizu-Wakamatsu

Fujioka

Fujisawa

Hadano

Himeji

Hitachi

Ichikawa

Kanuma

Kanzaki

Kashihara

Kashiwara

Kasuya

Kawasaki

Kitagunma

Kochi

Kodaira

Kumagaya

Kumamoto

Kure

Matsusaka

Mitaka

Moriguchi

Nagasaki

Naha

Nirasaki

Ohta

Okayama

Okinawa

Sakai

Shibukawa

Takatsuki

Toki

Tokushima

Tokyo

Toyoake

Ueda

Yatsushiro

Yokkaichi

Yokohama

Guadalajara

Monterrey

Tlalnepantla

Bełchatów

Bydgoszcz

Chełmno

Gdynia Na

Lubin

Lubliniec

Piekary Śląskie

Torun

Ząbki

Almada

Angra do Heroísmo

Coimbra

Lisbon

Porto

Brasov

Cluj-Napoca

Arkhangelsk

Gatchina

Krasnodar

Moscow

Nizhny Novgorod

Saint Petersburg

Saratov

Smolensk

Smolensk Region N/A

St-Peterburg

Tomsk Na

Yaroslavl

Yekaterinburg

Bratislava

Michalovce

Rimavská Sobota

Trenčín

Busan

Gwangju

Gyeonggi-do

Seoul

Alicante

Barakaldo

Barcelona

Coslada

Elche

Madrid

Zamora

Uppsala

Bali Township, Taipei County

Kaohsiung City

Taoyuan District

Hlevakha

Kharkiv

Kiev

Odesa

Poltava

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT01515423 - Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Patients With Schizophrenia | Biotech Hunter | Biotech Hunter