Who is sponsoring NCT00604279?

NCT00604279 is sponsored by Xian-Janssen Pharmaceutical Ltd..

What drugs are being tested in NCT00604279?

Interventions in NCT00604279: Paliperidone palmitate (R092670), Risperidone.

What condition does NCT00604279 study?

NCT00604279 studies Schizophrenia.

Is NCT00604279 still recruiting?

NCT00604279 is currently completed. Last updated 4 June 2013.

Are results published for NCT00604279?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2013-06-04 · How we verify

NCT00604279

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Randomized, Open-Label, Parallel Group Comparative Study of Paliperidone Palmitate (50, 100, 150 mg eq) and Risperidone LAI (25, 37.5, or 50 mg) in Subjects With Schizophrenia

Completed Phase 3 Results posted Last updated 4 June 2013

What this trial tests

Phase 3 trial testing Paliperidone palmitate (R092670) in Schizophrenia in 452 participants. Completed in 1 January 2009.

Timeline

1 January 2008

Primary endpoint
1 January 2009

1 January 2009

Quick facts

Lead sponsor	Xian-Janssen Pharmaceutical Ltd.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	452
Start date	1 January 2008
Primary completion	1 January 2009
Estimated completion	1 January 2009
Sites	8 locations across China

Drugs / interventions tested

Paliperidone palmitate (R092670) — full drug profile →
Risperidone (risperidone) — full drug profile →

Conditions studied

Schizophrenia — all drugs for Schizophrenia →

Sponsor

Xian-Janssen Pharmaceutical Ltd. — full company profile →

Who can join

18 and older, any sex, with Schizophrenia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 92 or Early Withdrawal
Time frame: Baseline, Day 92 or early withdrawal
The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 (absent) to 210 (extreme ps

Sponsor's own description

The purpose of this study is to compare the efficacy of paliperidone palmitate and risperidone long acting injection (LAI) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) along with safety and tolerability.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Schizophrenia

Currently open trials in the same condition.

NCT07424404 — A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Au · Phase 3 · recruiting
NCT07467993 — Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With Schizophrenia · Phase 2 · recruiting
NCT07379827 — Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT) · recruiting
NCT06758414 — CBT-CP for Veterans With SMI · NA · recruiting
NCT07395206 — Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Dis · NA · recruiting

Other Xian-Janssen Pharmaceutical Ltd. trials

Trials by the same sponsor.

NCT07310095 — A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD) · Phase 4 · recruiting
NCT07302360 — A Real-World Study of Guselkumab in Chinese Participants With Ulcerative Colitis · recruiting
NCT06082986 — A Retrospective Observational Study of Ustekinumab Among Bio-naive Participants With Crohn's Disease in China · completed
NCT03617016 — Preliminarily Evaluate the Efficacy of Domperidone in Adult Chinese Participants With Functional Dyspepsia · Phase 4 · completed
NCT03220867 — Bioequivalence Study of Xian Risperdal Tablets Compared With Gurabo Risperdal Tablets Under Fasting and Fed Conditions i · Phase 1 · withdrawn

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00604279 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Xian-Janssen Pharmaceutical Ltd.
Last refreshed: 4 June 2013

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00604279.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing