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| ID | Type | Description | Link |
|---|---|---|---|
| 305340 |
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The purpose of this study is to determine what effect Magnevist (gadopentetate dimeglumine) injection has on the way the heart conducts the electrical impulses that allow it to beat effectively. The study will compare Magnevist injection's effect to that of placebo (a saline injection).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Experimental |
| |
| Arm 3 | Experimental |
| |
| Arm 4 | Experimental |
| |
| Arm 5 | Active Comparator |
| |
| Arm 6 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gadopentetate dimeglumine (Magnevist, BAY86-4882) | Drug | 0,1mmol/kg at 10 mL/15 sec |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The primary study variable was heart-rate corrected QT (QTc) interval | Within 15 min postinjection |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event monitoring, laboratory evaluations | 24 hrs postinjection | |
| ECG variables and overall interpretation | 24 hrs postinjection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami | Florida | 33181-3405 | United States |
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| Gadopentetate dimeglumine (Magnevist, BAY86-4882) |
| Drug |
same dose as arm 1 at bolus rate (2mL/sec) |
|
| Gadopentetate dimeglumine (Magnevist, BAY86-4882) | Drug | 0,3mmol/kg at 10 mL/15 sec |
|
| Gadopentetate dimeglumine (Magnevist, BAY86-4882) | Drug | same dose as arm 3 at bolus rate (2mL/sec) |
|
| Moxifloxacin (BAY12-8039) | Drug | 400 mg at 0,07 mL/sec over 60 min |
|
| Placebo | Drug | 0,9% saline at 0,6mL/kg at bolus rate |
|
| ID | Term |
|---|---|
| D019786 | Gadolinium DTPA |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D004369 | Pentetic Acid |
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D056831 | Coordination Complexes |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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