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Sponsored by: |
Abraxis BioScience Inc. |
---|---|
Information provided by: | Abraxis BioScience Inc. |
ClinicalTrials.gov Identifier: | NCT00093223 |
This trial will treat patients with a new chemotherapeutic medicine who have undergone a successful and uncomplicated de novo stent placement in up to two native coronary arteries. The purpose of the trial is to determine the appropriate dose of the new medicine for future trials and to evaluate the incidence of treatment-emergent adverse events and serious adverse events.
Condition | Intervention | Phase |
---|---|---|
Angina Pectoris Coronary Artery Disease |
Drug: Paclitaxel Nanoparticle Albumin Bound |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study |
Enrollment: | 99 |
Study Start Date: | September 2001 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
35mg/m^2 infusion time is 3.5 minutes
|
Drug: Paclitaxel Nanoparticle Albumin Bound
Single or duel doses of 35mg/m^2 ABI-007, administered IV, administered after placement of denovo stent(s).
Drug: Paclitaxel Nanoparticle Albumin Bound
|
2: Experimental
2 doses of 35mg.m^2 with the second dose given 2 months later
|
Drug: Paclitaxel Nanoparticle Albumin Bound
Single or duel doses of 35mg/m^2 ABI-007, administered IV, administered after placement of denovo stent(s).
Drug: Paclitaxel Nanoparticle Albumin Bound
35mg/35 infusion time is 3.5 minutes
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
General Exclusion Criteria:
Exclusion Criteria Related to Angioplasty:
Exclusion Criteria Related to ABI-007:
United States, North Carolina | |
Abraxis BioScience, Inc. | |
Durham, North Carolina, United States, 27703 |
Study Director: | Angela Ogden, MD | Abraxis BioScience Inc. |
Responsible Party: | Abraxis BioScience ( Selena Rush, Senior Clinical Trials Manager ) |
Study ID Numbers: | CVR001-0 |
Study First Received: | October 4, 2004 |
Last Updated: | February 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00093223 |
Health Authority: | United States: Food and Drug Administration |
In-Stent Restenosis |
Arterial Occlusive Diseases Heart Diseases Myocardial Ischemia Angina Pectoris Vascular Diseases Pain Ischemia |
Arteriosclerosis Chest Pain Coronary Disease Signs and Symptoms Paclitaxel Coronary Artery Disease |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Mitosis Modulators Tubulin Modulators |
Cardiovascular Diseases Antimitotic Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions |