MedTrace Logo

A Safety, Tolerability, and Treatment Response Study of Paliperidone Palmitate Administered to Patients With Schizophrenia

NCT01051531 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 546

Last updated 2024-10-28

No results posted yet for this study

Summary

The purpose of the study is to evaluate the safety, tolerability and treatment response of paliperidone palmitate administered as once-monthly injections to patients with schizophrenia.

Conditions

Interventions

DRUG

Paliperidone palmitate

One intramuscular (IM) injection of paliperidone palmitate 150 mg equivalent (eq.) on Day 1, 100 mg eq. on Day 8, and 75 mg eq. on Day 38. Thereafter, one IM injection of paliperidone palmitate 50, 75, 100, or 150 mg eq. once monthly. Doses may be adjusted every 30 days per the clinician's judgment within the dose range of 50 to 150 mg eq.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-22
Primary Completion
2013-05-17
Completion
2013-05-17

Countries

  • Australia
  • China
  • Hong Kong
  • Malaysia
  • New Zealand
  • Philippines
  • South Korea
  • Taiwan
  • Thailand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01051531 on ClinicalTrials.gov