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| Sponsor: | Celgene Corporation |
|---|---|
| Information provided by (Responsible Party): | Celgene Corporation |
| ClinicalTrials.gov Identifier: | NCT00124943 |
Purpose
The purpose of this study is to investigate the use of systemic intracoronary administration of albumin-bound paclitaxel, ABI-007, for the prevention and reduction of restenosis following de novo stenting or following angioplasty for in-stent restenosis.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Restenosis |
Drug: ABI-007 |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I/II Safety Trial of Intracoronary Administration of Systemic Nanoparticle Paclitaxel (ABI-007) for the Prevention of In-Stent Restenosis |
| Enrollment: | 112 |
| Study Start Date: | July 2005 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: ABI-007
10mg/m^2 ABI-007
|
| Experimental: 2 |
Drug: ABI-007
22mg/m^2 ABI-007
|
| Experimental: 3 |
Drug: ABI-007
35mg^2 ABI-007
|
| Experimental: 4 |
Drug: ABI-007
45mg/m^2 ABI-007
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The following lab values at baseline are exclusionary:
Contacts and Locations
More Information
| Responsible Party: | Celgene Corporation |
| ClinicalTrials.gov Identifier: | NCT00124943 History of Changes |
| Other Study ID Numbers: | CVR003 |
| Study First Received: | July 27, 2005 |
| Last Updated: | October 6, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Prevention of Instent Restenosis |
|
Coronary Restenosis Coronary Stenosis Coronary Disease Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Paclitaxel |
Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |