Cardiovascular Safety Study of Magnevist® Injection at Two Dose Levels and Two Injection Rates in Normal Subjects

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00310596
• Collaborator: (none)
• Enrollment: 71
• Location: 1
• Arms: 6
• Duration (Months): 2
• Patients Per Site Per Month: 36

Study Details

Study Description

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 injection's effect to that of placebo (a saline injection).

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882); Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882); Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882); Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882); Drug: Moxifloxacin (BAY12-8039); Drug: Placebo	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 71 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: 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
• Study Start Date: Jan 1, 2004
• Actual Study Completion Date: Mar 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882); 0,1mmol/kg at 10 mL/15 sec
Experimental: Arm 2	Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882); same dose as arm 1 at bolus rate (2mL/sec)
Experimental: Arm 3	Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882); 0,3mmol/kg at 10 mL/15 sec
Experimental: Arm 4	Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882); same dose as arm 3 at bolus rate (2mL/sec)
Active Comparator: Arm 5	Drug: Moxifloxacin (BAY12-8039); 400 mg at 0,07 mL/sec over 60 min
Placebo Comparator: Arm 6	Drug: Placebo; 0,9% saline at 0,6mL/kg at bolus rate

Outcome Measures

Primary Outcome Measures

1. The primary study variable was heart-rate corrected QT (QTc) interval [Within 15 min postinjection]

Secondary Outcome Measures

1. Adverse event monitoring, laboratory evaluations [24 hrs postinjection]

2. ECG variables and overall interpretation [24 hrs postinjection]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Miami	Florida	United States	33181-3405

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT00310596
• Other Study ID Numbers: 91024; 305340
• First Posted: Apr 4, 2006
• Last Update Posted: Dec 30, 2014
• Last Verified: Dec 1, 2014

• Keywords provided by Bayer: ECG safety
• Additional relevant MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Study Results

No Results Posted as of Dec 30, 2014