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NCT01559272 · ClinicalTrials.gov registry record · Phase 1

A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Paliperidone Palmitate in Patients With Schizophrenia

A Phase 1 study of Schizophrenia, sponsored by Janssen Research & Development.

Completed
Registry status
Phase 1
Development phase
328
Enrollment target
20
Study locations

NCT01559272 is a Phase 1 study of Schizophrenia that has completed, run by Janssen Research & Development. The registered enrollment target is 328 participants, above the 218-participant average among 315 other Schizophrenia trials with a reported enrollment target (50% higher). The trial reports 20 study locations across 6 states.

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The verdict

NCT01559272, a Phase 1 study of Schizophrenia, has completed, sponsored by Janssen Research & Development.

COMPLETED
Registry status
Phase 1
Development phase
328 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to assess the pharmacokinetics, safety, and tolerability of a paliperidone palmitate 3-month formulation in patients with schizophrenia.

Conditions Studied

Interventions

  • DRUG Paliperidone IR (Period 1)
  • DRUG Paliperidone palmitate F015 (Panel A: treatment group 1)
  • DRUG Paliperidone palmitate F015 (Panel A: treatment group 2)
  • DRUG Paliperidone palmitate F015 (Panel B: treatment group 1)
  • DRUG Paliperidone palmitate F015 (Panel B: treatment group 2)

Study Locations (20)

Other

  • - Aalst
  • - Diest
  • - Burgas
  • - Zagreb
  • - Beer Yaakov
  • - Hod HaSharon
  • - Ramat Gan
  • - Johor Bahru
  • - Kuala Lumpur
  • - Perak

California

  • - Cerritos
  • - Garden Grove
  • - Glendale
  • - National City
  • - Paramount

Texas

  • - Austin
  • - DeSoto

Arkansas

  • - Little Rock

Georgia

  • - Atlanta

Pennsylvania

  • - Philadelphia

Trial Details

FieldValue
Enrollment Target 328 participants
Start Date 2008-02-21
Est. Completion 2014-05-24
Phase Phase 1

Sponsor

Janssen Research & Development

593 total trials

What the Registry Record Tells You About NCT01559272

The ClinicalTrials.gov registry entry for NCT01559272 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 328 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 218-participant average among 315 other Schizophrenia trials with a reported enrollment target (50% 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 Paliperidone IR (Period 1) is the first listed.

NCT01559272 reports 20 study locations spanning 6 distinct geographic areas - top geographies include Other, California, Texas.

Frequently Asked Questions

What is clinical trial NCT01559272 about?

NCT01559272 is a clinical study titled "A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Paliperidone Palmitate in Patients With Schizophrenia". The purpose of this study is to assess the pharmacokinetics, safety, and tolerability of a paliperidone palmitate 3-month formulation in patients with schizophrenia.

What is the current status of trial NCT01559272?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 328 participants. The study started on 2008-02-21. Estimated completion is 2014-05-24.

What conditions does trial NCT01559272 study?

This clinical trial studies the following conditions: Schizophrenia.

What interventions are being tested in trial NCT01559272?

The interventions under investigation include: Paliperidone IR (Period 1) (DRUG), Paliperidone palmitate F015 (Panel A: treatment group 1) (DRUG), Paliperidone palmitate F015 (Panel A: treatment group 2) (DRUG), Paliperidone palmitate F015 (Panel B: treatment group 1) (DRUG), Paliperidone palmitate F015 (Panel B: treatment group 2) (DRUG).

Who is sponsoring clinical trial NCT01559272?

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

Where is trial NCT01559272 being conducted?

This trial has 20 study locations across Arkansas, California, Georgia, Pennsylvania, Texas. 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.