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| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 2, 1999 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00002131 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | A Pilot Study of OPC-8212 (Vesnarinone) in Persons With AIDS-Related Kaposi's Sarcoma |
| Official Title ICMJE | A Pilot Study of OPC-8212 (Vesnarinone) in Persons With AIDS-Related Kaposi's Sarcoma |
| Brief Summary | To examine the safety and efficacy of two doses of vesnarinone in patients with AIDS-related Kaposi's sarcoma. |
| Detailed Description | Twenty-eight patients (14 per cohort) receive daily vesnarinone at one of two doses. At least seven patients at the lower dose must have completed 2 weeks of therapy before subsequent patients are entered at the higher dose. Patients who successfully complete 16 weeks of treatment may receive maintenance therapy for the duration of the study (approximately 12-18 months). |
| Study Phase | Phase II |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Open Label, Safety Study |
| Condition ICMJE |
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| Intervention ICMJE | Drug: Vesnarinone |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 28 |
| Completion Date | |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Inclusion Criteria Concurrent Medication: Allowed:
Concurrent Treatment: Allowed:
Patients must have:
Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded:
Concurrent Medication: Excluded:
Concurrent Treatment: Excluded:
Patients with the following prior conditions are excluded:
Prior Medication: Excluded:
Excluded within 30 days prior to study entry:
Prior Treatment: Excluded within 30 days prior to study entry:
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| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00002131 |
| Responsible Party | |
| Study ID Numbers ICMJE | 234D, 22-93-254 |
| Study Sponsor ICMJE | Otsuka America Pharmaceutical |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | NIH AIDS Clinical Trials Information Service |
| Verification Date | April 1996 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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