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

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ClinicalTrials.gov Identifier: NCT00581243
Recruitment Status : Terminated
First Posted : December 27, 2007
Last Update Posted : July 21, 2009
Sponsor:
Collaborator:
Solvay Pharmaceuticals
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

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

Condition or disease Intervention/treatment Phase
Healthy Drug: SLV-313 SR Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
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
Study Start Date : January 2008
Estimated Primary Completion Date : May 2008
Estimated Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Observe safety and tolerability [ Time Frame: 25 days ]

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


Information from the National Library of Medicine

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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

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

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00581243     History of Changes
Other Study ID Numbers: 3170A1-01001
First Posted: December 27, 2007    Key Record Dates
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