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

Last updated on May 11, 2018

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-50 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Men, aged 18-50 years old

- Women, aged 18-50 years old

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Non-lactating women, aged 18-50 years old

- Non-pregnant women, aged 18-50 years old

NCT00581243
Pfizer
Terminated
Study Evaluating Safety and Tolerability of Ascending Multiple Dose of SLV-313 in Schizophrenia Patients

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Study Evaluating Safety and Tolerability of Ascending Multiple Dose of SLV-313 in Schizophrenia Patients
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
Randomized, inpatient, ascending multiple dose study given to subjects with schizophrenia and schizoaffective disorder to assess safety and tolerability.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Healthy
Drug: SLV-313 SR
sustained relase tablets taken once daily for 14 days
  • Experimental: 1
    2 mg SLV-313 SR (fixed dose)
    Intervention: Drug: SLV-313 SR
  • Experimental: 2
    5 mg SLV-313 SR (fixed dose)
    Intervention: Drug: SLV-313 SR
  • Experimental: 3
    10 mg SLV-313 SR (fixed dose)
    Intervention: Drug: SLV-313 SR
  • Experimental: 4
    xx mg SLV-313 SR (titration)
    Intervention: Drug: SLV-313 SR
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
32
May 2008
May 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00581243
3170A1-01001
No
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Solvay Pharmaceuticals
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
July 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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