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

NCT ID: NCT00310596

Last Updated: 2014-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2004-03-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Healthy

Keywords

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ECG safety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Intervention Type DRUG

0,1mmol/kg at 10 mL/15 sec

Arm 2

Group Type EXPERIMENTAL

Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Intervention Type DRUG

same dose as arm 1 at bolus rate (2mL/sec)

Arm 3

Group Type EXPERIMENTAL

Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Intervention Type DRUG

0,3mmol/kg at 10 mL/15 sec

Arm 4

Group Type EXPERIMENTAL

Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Intervention Type DRUG

same dose as arm 3 at bolus rate (2mL/sec)

Arm 5

Group Type ACTIVE_COMPARATOR

Moxifloxacin (BAY12-8039)

Intervention Type DRUG

400 mg at 0,07 mL/sec over 60 min

Arm 6

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

0,9% saline at 0,6mL/kg at bolus rate

Interventions

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Gadopentetate dimeglumine (Magnevist, BAY86-4882)

0,1mmol/kg at 10 mL/15 sec

Intervention Type DRUG

Gadopentetate dimeglumine (Magnevist, BAY86-4882)

same dose as arm 1 at bolus rate (2mL/sec)

Intervention Type DRUG

Gadopentetate dimeglumine (Magnevist, BAY86-4882)

0,3mmol/kg at 10 mL/15 sec

Intervention Type DRUG

Gadopentetate dimeglumine (Magnevist, BAY86-4882)

same dose as arm 3 at bolus rate (2mL/sec)

Intervention Type DRUG

Moxifloxacin (BAY12-8039)

400 mg at 0,07 mL/sec over 60 min

Intervention Type DRUG

Placebo

0,9% saline at 0,6mL/kg at bolus rate

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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305340

Identifier Type: -

Identifier Source: secondary_id

91024

Identifier Type: -

Identifier Source: org_study_id