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NCT01290302 · ClinicalTrials.gov registry record · Phase 1
Blinded Cross-Over Bioequivalence (BE) Trial of Luitpold Azacitidine vs Vidaza
A Phase 1 study of Chronic Lymphocytic Leukemia and Myelodysplastic Syndrome, sponsored by American Regent.
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
- 1
- Study location
NCT01290302 is a Phase 1 study of Chronic Lymphocytic Leukemia and Myelodysplastic Syndrome that has completed, run by American Regent. The registered enrollment target is 38 participants, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01290302, a Phase 1 study of Chronic Lymphocytic Leukemia and Myelodysplastic Syndrome, has completed, sponsored by American Regent.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to assess the bioequivalence of subcutaneous Vidaza® and subcutaneous Luitpold Azacitidine pharmacokinetics and to assess the comparative safety of subcutaneous Vidaza® versus subcutaneous Luitpold Azacitidine.
Conditions Studied
Interventions
- DRUG Luitpold Azacitidine
- DRUG Vidaza®
Study Locations (1)
Pennsylvania
- Luitpold Pharmaceuticals, Inc. - Norristown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2010-11-22 |
| Est. Completion | 2012-12-21 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01290302
The ClinicalTrials.gov registry entry for NCT01290302 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (79% lower). The listed sponsor is American Regent, which has 34 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Luitpold Azacitidine is the first listed.
NCT01290302 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01290302 about?
NCT01290302 is a clinical study titled "Blinded Cross-Over Bioequivalence (BE) Trial of Luitpold Azacitidine vs Vidaza". The purpose of this study is to assess the bioequivalence of subcutaneous Vidaza® and subcutaneous Luitpold Azacitidine pharmacokinetics and to assess the comparative safety of subcutaneous Vidaza® versus subcutaneous Luitpold Azacitidine.
What is the current status of trial NCT01290302?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2010-11-22. Estimated completion is 2012-12-21.
What conditions does trial NCT01290302 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Myelodysplastic Syndrome, Myelofibrosis, Chronic Myeloid Leukemia.
What interventions are being tested in trial NCT01290302?
The interventions under investigation include: Luitpold Azacitidine (DRUG), Vidaza® (DRUG).
Who is sponsoring clinical trial NCT01290302?
This trial is sponsored by American Regent, which has 34 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01290302 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.