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Twice Daily Titration Study of Bifeprunox in Subjects With Schizophrenia

This study has been completed.
Sponsor:
Collaborators:
H. Lundbeck A/S
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00139906
First received: August 30, 2005
Last updated: January 15, 2015
Last verified: March 2006
  Purpose
This study is to assess the safety and tolerability of a five-day titration schedule (using twice daily dosing for the first three days) to achieve the highest proposed dose of 40 mg daily. The study duration is two months.

Condition Intervention Phase
Schizophrenia Schizoaffective Disorder Drug: Bifeprunox Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Twice Daily Titration Study of the Safety and Tolerability of Bifeprunox in Subjects With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Solvay Pharmaceuticals:

Study Start Date: August 2005
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who have current diagnosis of Schizophrenia or Schizoaffective disorder
  • Body weight of 100-250 lbs
  • Male or females
  • 18-55 years of age

Exclusion Criteria:

  • Subjects who are acutely psychotic
  • Subjects with current Axis I primary psychiatric diagnosis other than schizophrenia, at significant risk of suicide
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00139906

Locations
United States, California
Site 1
National City, California, United States
Sponsors and Collaborators
Solvay Pharmaceuticals
H. Lundbeck A/S
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

ClinicalTrials.gov Identifier: NCT00139906     History of Changes
Other Study ID Numbers: S154.2.016
Study First Received: August 30, 2005
Last Updated: January 15, 2015

Keywords provided by Solvay Pharmaceuticals:
Titration Study
Schizophrenia
BID dosing
Pharmacokinetic

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 21, 2017