Study Evaluating Safety and Tolerability of Ascending Multiple Dose of SLV-313 in Schizophrenia Patients

This study has been terminated.
Sponsor:
Collaborator:
Solvay Pharmaceuticals
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00581243
First received: December 21, 2007
Last updated: July 20, 2009
Last verified: July 2009
  Purpose

Randomized, inpatient, ascending multiple dose study given to subjects with schizophrenia and schizoaffective disorder to assess safety and tolerability.


Condition Intervention Phase
Healthy
Drug: SLV-313 SR
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: An Ascending Multiple-Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of SLV-313 Sustained-Release (SR) Tablets Administered Orally to Subjects With Schizophrenia and Schizoaffective Disorder

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Observe safety and tolerability [ Time Frame: 25 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • PK and PD profile [ Time Frame: 25 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: January 2008
Estimated Study Completion Date: May 2008
Estimated Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
2 mg SLV-313 SR (fixed dose)
Drug: SLV-313 SR
sustained relase tablets taken once daily for 14 days
Experimental: 2
5 mg SLV-313 SR (fixed dose)
Drug: SLV-313 SR
sustained relase tablets taken once daily for 14 days
Experimental: 3
10 mg SLV-313 SR (fixed dose)
Drug: SLV-313 SR
sustained relase tablets taken once daily for 14 days
Experimental: 4
xx mg SLV-313 SR (titration)
Drug: SLV-313 SR
sustained relase tablets taken once daily for 14 days

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men, aged 18-50 years old
  • Women, aged 18-50 years old

Exclusion Criteria:

  • Non-lactating women, aged 18-50 years old
  • Non-pregnant women, aged 18-50 years old
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00581243

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Solvay Pharmaceuticals
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00581243     History of Changes
Other Study ID Numbers: 3170A1-01001
Study First Received: December 21, 2007
Last Updated: July 20, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Safety,Tolerability, Schizophrenia

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014