Ignite Creation Date:
2025-12-24 @ 6:30 PM
Ignite Modification Date:
2026-01-04 @ 10:00 AM
Study NCT ID:
NCT00620568
Status:
TERMINATED
Last Update Posted:
2009-08-04
First Post:
2008-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating Multiple Ascending Dose in Schizophrenia Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-08-03', 'studyFirstSubmitDate': '2008-02-08', 'studyFirstSubmitQcDate': '2008-02-08', 'lastUpdatePostDateStruct': {'date': '2009-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Observe safety and tolerability', 'timeFrame': '25 days'}], 'secondaryOutcomes': [{'measure': 'PK and PD profile', 'timeFrame': '25 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Safety', 'Tolerability', 'Schizophrenia'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This is a randomized, inpatient, ascending multiple dose study to assess safety and tolerability of SLV-313 SR tablets administered orally to subjects with schizophrenia and schizoaffective disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men, aged 18-50 years old\n* Women, aged 18-50 years old\n\nExclusion Criteria:\n\n* Non-lactating women, aged 18-50 years old\n* Non-pregnant women, aged 18-50 years old'}, 'identificationModule': {'nctId': 'NCT00620568', 'briefTitle': 'Study Evaluating Multiple Ascending Dose in Schizophrenia Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '3170A1-1001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: SLV-313 SR']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: SLV-313 SR']}, {'type': 'EXPERIMENTAL', 'label': '3', 'interventionNames': ['Drug: SLV-313 SR']}, {'type': 'EXPERIMENTAL', 'label': '4', 'interventionNames': ['Drug: SLV-313 SR']}], 'interventions': [{'name': 'SLV-313 SR', 'type': 'DRUG', 'description': 'sustained release tablets taken once daily for 14 days', 'armGroupLabels': ['1', '2', '3', '4']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Wyeth is now a wholly owned subsidiary of Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Solvay Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Wyeth (Registry Contact: Clinical Trial Registry Specialist)', 'oldOrganization': 'Wyeth'}}}}