Comparison of Paliperidone Palmitate and RISPERDAL CONSTA in Patients With Schizophrenia

PHASE3CompletedINTERVENTIONAL
Enrollment

1,221

Participants

Timeline

Start Date

March 31, 2007

Primary Completion Date

June 30, 2009

Study Completion Date

June 30, 2009

Conditions
Schizophrenia
Interventions
DRUG

RISPERDAL CONSTA

RISPERDAL CONSTA: Type=exact number, unit=mg, number=25, 37.5, or 50, form=suspension for injection, route=Intramuscular use. One i.m. injection of RISPERDAL CONSTA 25-50 mg eq every 2 weeks at V4, V6, V7, V8, V9, and V10. PALIPERIDONE PALMITATE PLACEBO: Form=suspension for injection, route=Intramuscular use. One i.m. injection every 2 weeks at Baseline and at V4, V7, and V9. RISPERIDONE: Type=up to, unit=mg, number=1 to 6, form=Tablet, route=Oral Use. One tablet for the first 4 weeks (28 days) of the DB treatment period.

DRUG

Paliperidone palmitate

PALIPERIDONE PALMITATE: Type=exact number, unit=mg, number=50, 100, or 150, form=suspension for injection, route=Intramuscular use. One i.m. injection of Paliperidone palmitate 50-150 mg eq every 4 wks at Baseline, V4, V7, and V9. RISPERDAL CONSTA PLACEBO: Form=suspension for injection, route=Intramuscular use. One i.m. injection every 4 weeks at Baseline, V4, V7, and V9.

Trial Locations (82)

Unknown

Birmingham

Little Rock

Cerritos

Garden Grove

Los Angeles

Washington D.C.

Atlanta

Chicago

Flowood

Hollis

Willoughby

Oklahoma City

DeSoto

Houston

Odessa

Linz

Salzburg

Vienna

Plovdiv

Varna

Brno

Dobřany

Kroměříž

Kutná Hora

Olomouc

Prague

Pärnu

Tallinn

Tartu

Bourges Cedex N/A

Dole

Romans-sur-Isère

Achim

Berlin

Bielefeld

Bochum

Jena

Leipzig

Mannheim

München

Stralsund

Baja

Budapest

Gyõr

Kalocsa

Nagykálló

Aurangabad

Bangalore

Chandigarh

Mangalore

Pune

Varanasi

Alytus

Kaunas

Klaipėda

Vilnius

Bełchatów

Bytom Na

Chełmno

Gdynia Na

Katowice Woj Slaskie

Krakow Na

Lubliniec

Piekary Slaskie Na

Skorzewo Na

Warszawa Na

Moscow

Moscow Russia

Nizny Novgorod

Saint Petersburg

Saratov

Yaroslavl

Barcelona

Madrid

San Juan

Dnipro

Donetsk

Kharkiv

Kiev

Kyiv

Odesa

Simferopol

All Listed Sponsors
lead

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

INDUSTRY

NCT00589914 - Comparison of Paliperidone Palmitate and RISPERDAL CONSTA in Patients With Schizophrenia | Biotech Hunter | Biotech Hunter