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Sponsored by: |
TargeGen |
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Information provided by: | TargeGen |
ClinicalTrials.gov Identifier: | NCT00103350 |
TG100-115 is able to reduce the size of heart attacks in pre-clinical models. The hypothesis of this study is that TG100-115 can be given safely to patients who suffer a heart attack and undergo angioplasty to restore blood flow. We will also evaluate whether TG100-115 reduces heart muscle damage.
Condition | Intervention | Phase |
---|---|---|
Myocardial Infarction |
Drug: TG100-115 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 1-2, Multicenter, Randomized, Double-Blind, Placebo Controlled, Prospective Study to Evaluate the Safety and Potential Efficacy of Single, Increasing Doses of TG100-115 in Subjects Undergoing Percutaneous Coronary Intervention for Acute Anterior ST Elevation Myocardial Infarction |
Estimated Enrollment: | 100 |
Study Start Date: | January 2005 |
Study Completion Date: | January 2008 |
Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | TG001-03 |
Study First Received: | February 7, 2005 |
Last Updated: | May 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00103350 |
Health Authority: | United States: Food and Drug Administration |
myocardial infarction infarct size angioplasty percutaneous coronary intervention Acute Myocardial Infarction |
Necrosis Heart Diseases Myocardial Ischemia Vascular Diseases |
Ischemia Infarction Myocardial Infarction |
Pathologic Processes Cardiovascular Diseases |