Ignite Creation Date:
2024-05-05 @ 4:48 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00310596
Status:
COMPLETED
Last Update Posted:
2014-12-30
First Post:
2006-03-31
Brief Title:
Cardiovascular Safety Study of Magnevist Injection at Two Dose Levels and Two Injection Rates in Normal Subjects
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
Cardiovascular Safety Study of 01 and 03 mmolkg Magnevist Injection at Two Injection Rates Bolus and 10 mL15 Sec in Normal Subjects Following a Randomized Cross-over Design Using Placebo and a Concurrent Positive Control
Status:
COMPLETED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 injections effect to that of placebo a saline injection
Detailed Description:
This study has previously been posted by Berlex Inc Berlex Inc has been renamed to Bayer HealthCare Pharmaceuticals IncBayer HealthCare Pharmaceuticals Incis the sponsor of the trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 305340 | None | None | None |