Study Evaluating Safety and Tolerability of Ascending Multiple Dose of SLV-313 in Schizophrenia Patients
NCT00581243
Last updated date
ABOUT THIS STUDY
Randomized, inpatient, ascending multiple dose study given to subjects with schizophrenia and
schizoaffective disorder to assess safety and tolerability.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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Eligibility Criteria
condition
Healthy
Sex
Females and Males
Age
18-50 years
Inclusion Criteria
Show details
- Men, aged 18-50 years old
- Women, aged 18-50 years old
Exclusion Criteria
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- Non-lactating women, aged 18-50 years old
- Non-pregnant women, aged 18-50 years old
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Advanced Information
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Study Evaluating Safety and Tolerability of Ascending Multiple Dose of SLV-313 in Schizophrenia Patients | |||
Official Title ICMJE | 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 | |||
Brief Summary | Randomized, inpatient, ascending multiple dose study given to subjects with schizophrenia and schizoaffective disorder to assess safety and tolerability. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE | Healthy | |||
Intervention ICMJE | Drug: SLV-313 SR
sustained relase tablets taken once daily for 14 days | |||
Study Arms ICMJE |
| |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Estimated Enrollment ICMJE | 32 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Estimated Study Completion Date ICMJE | May 2008 | |||
Estimated Primary Completion Date | May 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 50 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00581243 | |||
Other Study ID Numbers ICMJE | 3170A1-01001 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth | |||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators ICMJE | Solvay Pharmaceuticals | |||
Investigators ICMJE |
| |||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | July 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |