Cardiovascular Safety Study of Magnevist® Injection at Two Dose Levels and Two Injection Rates in Normal Subjects
December 29, 2014 updated by: Bayer
Cardiovascular Safety Study of 0.1 and 0.3 mmol/kg Magnevist® Injection at Two Injection Rates (Bolus and 10 mL/15 Sec.) in Normal Subjects Following a Randomized, Cross-over Design Using Placebo and a Concurrent Positive Control
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).
Study Overview
Status
Completed
Conditions
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
71
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33181-3405
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects with an electrocardiogram [ECG] (normal sinus rhythm [SR], QTc > 450 msec) without clinically significant abnormalities
- Non-smoker
Exclusion Criteria:
- History of cardiovascular disease- Pregnant or nursing- Had any contraindication to moxifloxacin
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Arm 1
|
0,1mmol/kg at 10 mL/15 sec
same dose as arm 1 at bolus rate (2mL/sec)
0,3mmol/kg at 10 mL/15 sec
same dose as arm 3 at bolus rate (2mL/sec)
|
|
EXPERIMENTAL: Arm 2
|
0,1mmol/kg at 10 mL/15 sec
same dose as arm 1 at bolus rate (2mL/sec)
0,3mmol/kg at 10 mL/15 sec
same dose as arm 3 at bolus rate (2mL/sec)
|
|
EXPERIMENTAL: Arm 3
|
0,1mmol/kg at 10 mL/15 sec
same dose as arm 1 at bolus rate (2mL/sec)
0,3mmol/kg at 10 mL/15 sec
same dose as arm 3 at bolus rate (2mL/sec)
|
|
EXPERIMENTAL: Arm 4
|
0,1mmol/kg at 10 mL/15 sec
same dose as arm 1 at bolus rate (2mL/sec)
0,3mmol/kg at 10 mL/15 sec
same dose as arm 3 at bolus rate (2mL/sec)
|
|
ACTIVE_COMPARATOR: Arm 5
|
400 mg at 0,07 mL/sec over 60 min
|
|
PLACEBO_COMPARATOR: Arm 6
|
0,9% saline at 0,6mL/kg at bolus rate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The primary study variable was heart-rate corrected QT (QTc) interval
Time Frame: Within 15 min postinjection
|
Within 15 min postinjection
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Adverse event monitoring, laboratory evaluations
Time Frame: 24 hrs postinjection
|
24 hrs postinjection
|
|
ECG variables and overall interpretation
Time Frame: 24 hrs postinjection
|
24 hrs postinjection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2004
Study Completion (ACTUAL)
March 1, 2004
Study Registration Dates
First Submitted
March 31, 2006
First Submitted That Met QC Criteria
April 3, 2006
First Posted (ESTIMATE)
April 4, 2006
Study Record Updates
Last Update Posted (ESTIMATE)
December 30, 2014
Last Update Submitted That Met QC Criteria
December 29, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Anti-Bacterial Agents
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral, Combined
- Contraceptives, Oral
- Contraceptive Agents, Female
- Moxifloxacin
- Norgestimate, ethinyl estradiol drug combination
Other Study ID Numbers
- 91024
- 305340
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.