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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00581243
First Posted: December 27, 2007
Last Update Posted: July 21, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Solvay Pharmaceuticals
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
  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
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • PK and PD profile [ Time Frame: 25 days ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00581243     History of Changes
Other Study ID Numbers: 3170A1-01001
First Submitted: December 21, 2007
First Posted: December 27, 2007
Last Update Posted: July 21, 2009
Last Verified: July 2009

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

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