check_circleStudy Completed
Healthy
Bayer Identifier:
91024
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Cardiovascular safety study of Magnevist® Injection at two dose levels and two injection rates in normal subjects
Trial purpose
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).
Key Participants Requirements
Sex
BothAge
18 YearsTrial summary
Enrollment Goal
71Trial Dates
January 2004 - March 2004Phase
Phase 1Could I Receive a placebo
YesProducts
Magnevist (Gadopentetate Dimeglumine, BAY86-4882)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | SFBC International | Miami, 33181-3405, United States |
Primary Outcome
- The primary study variable was heart-rate corrected QT (QTc) intervaldate_rangeTime Frame:Within 15 min postinjectionenhanced_encryptionNoneSafety Issue:
Secondary Outcome
- Adverse event monitoring, laboratory evaluationsdate_rangeTime Frame:24 hrs postinjectionenhanced_encryptionNoneSafety Issue:
- ECG variables and overall interpretationdate_rangeTime Frame:24 hrs postinjectionenhanced_encryptionNoneSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
DiagnosticAllocation
RandomizedBlinding
Double BlindAssignment
Crossover AssignmentTrial Arms
6