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

Bayer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Moxifloxacin (BAY12-8039); Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00310596

305340

91024

Details and patient eligibility

About

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).

Full 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.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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71 participants in 6 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Arm 2

Experimental group

Treatment:

Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Arm 3

Experimental group

Treatment:

Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Arm 4

Experimental group

Treatment:

Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Arm 5

Active Comparator group

Treatment:

Drug: Moxifloxacin (BAY12-8039)

Arm 6

Placebo Comparator group

Treatment:

Drug: Placebo