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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00310544 |
The purpose of this study is to determine the dose of drug which is most effective in the delineation of dead heart muscle.
Condition | Intervention | Phase |
---|---|---|
Myocardial Infarction |
Drug: Magnevist (Gadopentetate dimeglumine, BAY86-4882) |
Phase II |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Single Blind (Subject), Dose Comparison, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Multicenter, Single-Blind, Randomized, Intraindividual Study of the Safety and Efficacy of Magnevist Gadopentetate Dimeglumine (Magnevist® Injection) at 0.1 and 0.2 Mmol/kg for the Depiction of Delayed Enhancement in Patients With Documented Myocardial Infarction |
Enrollment: | 79 |
Study Start Date: | February 2006 |
Study Completion Date: | October 2006 |
Arms | Assigned Interventions |
---|---|
Arm 2: Experimental |
Drug: Magnevist (Gadopentetate dimeglumine, BAY86-4882)
One intravenous injection per period. Period 1 and 2 are separated by 4 to 14 days. period 1: Magnevist 0.2 mmol/kg body weight period 2: Magnevist 0.1 mmol/kg body weight |
Arm 1: Experimental |
Drug: Magnevist (Gadopentetate dimeglumine, BAY86-4882)
One intravenous injection per period. Period 1 and 2 are separated by 4 to 14 days. period1:Magnevist 0.1 mmol/kg body weight period 2: Magnevist 0.2 mmol/kg body weight |
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.
Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
San Diego, California, United States, 92103 | |
United States, North Carolina | |
Winston-Salem, North Carolina, United States, 27103 | |
United States, Oklahoma | |
Tulsa, Oklahoma, United States, 74133 | |
United States, Oregon | |
Portland, Oregon, United States, 97239 | |
United States, Pennsylvania | |
Pittsburgh, Pennsylvania, United States, 15212-4772 | |
Hershey, Pennsylvania, United States, 17033 | |
Argentina | |
Buenos Aires, Argentina, C1428BKN |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer Healthcare Pharmaceuticals Inc. ( Therapeutic Area Head ) |
Study ID Numbers: | 91230, DE-03899, 306947 |
Study First Received: | March 31, 2006 |
Last Updated: | November 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00310544 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Necrosis Heart Diseases Myocardial Ischemia Vascular Diseases |
Ischemia Infarction Myocardial Infarction |
Necrosis Heart Diseases Pathologic Processes Myocardial Ischemia Vascular Diseases |
Cardiovascular Diseases Ischemia Infarction Myocardial Infarction |