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NCT01515423 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Schizophrenia, sponsored by Janssen Research & Development.

Completed
Registry status
Phase 3
Development phase
1,429
Enrollment target
20
Study locations

NCT01515423 is a Phase 3 study of Schizophrenia that has completed, run by Janssen Research & Development. The registered enrollment target is 1,429 participants, above the 214-participant average among 315 other Schizophrenia trials with a reported enrollment target (568% higher). The trial reports 20 study locations across 13 states.

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The verdict

NCT01515423, a Phase 3 study of Schizophrenia, has completed, sponsored by Janssen Research & Development.

COMPLETED
Registry status
Phase 3
Development phase
1,429 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to demonstrate that a paliperidone palmitate 3 month formulation (PP3M) is as effective as the paliperidone palmitate 1 month formulation (PP1M) in the treatment of patients with schizophrenia who have been stabilized on PP1M.

Conditions Studied

Interventions

  • DRUG PP3M 350 mg eq.
  • DRUG PP3M 525 mg eq.
  • DRUG PP3M 175 mg eq.
  • DRUG PP3M 263 mg eq.
  • DRUG Placebo (20% Intralipid)

Study Locations (20)

California

  • - Glendale
  • - Long Beach
  • - Oakland
  • - Oceanside
  • - Orange
  • - San Diego

Florida

  • - Bradenton
  • - Kissimmee
  • - Tampa

Arkansas

  • - Little Rock

Connecticut

  • - New Britain

Kansas

  • - Wichita

Michigan

  • - East Lansing

Missouri

  • - St Louis

Nevada

  • - Las Vegas

Trial Details

FieldValue
Enrollment Target 1,429 participants
Start Date 2012-05
Est. Completion 2015-03
Phase Phase 3

Sponsor

Janssen Research & Development

593 total trials

What the Registry Record Tells You About NCT01515423

The ClinicalTrials.gov registry entry for NCT01515423 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,429 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 214-participant average among 315 other Schizophrenia trials with a reported enrollment target (568% higher). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Schizophrenia appearing as the primary indexed condition, and to 5 interventions - of which PP3M 350 mg eq. is the first listed.

NCT01515423 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, Florida, Arkansas.

Frequently Asked Questions

What is clinical trial NCT01515423 about?

NCT01515423 is a clinical study titled "Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Patients With Schizophrenia". The purpose of this study is to demonstrate that a paliperidone palmitate 3 month formulation (PP3M) is as effective as the paliperidone palmitate 1 month formulation (PP1M) in the treatment of patients with schizophrenia who have been stabilized on PP1M.

What is the current status of trial NCT01515423?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,429 participants. The study started on 2012-05. Estimated completion is 2015-03.

What conditions does trial NCT01515423 study?

This clinical trial studies the following conditions: Schizophrenia.

What interventions are being tested in trial NCT01515423?

The interventions under investigation include: PP3M 350 mg eq. (DRUG), PP3M 525 mg eq. (DRUG), PP3M 175 mg eq. (DRUG), PP3M 263 mg eq. (DRUG), Placebo (20% Intralipid) (DRUG).

Who is sponsoring clinical trial NCT01515423?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01515423 being conducted?

This trial has 20 study locations across Arkansas, California, Connecticut, Florida, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.