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

NCT00310596 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2014-12-30

No results posted yet for this study

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).

Conditions

  • Healthy

Interventions

DRUG

Gadopentetate dimeglumine (Magnevist, BAY86-4882)

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

DRUG

Gadopentetate dimeglumine (Magnevist, BAY86-4882)

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

DRUG

Gadopentetate dimeglumine (Magnevist, BAY86-4882)

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

DRUG

Gadopentetate dimeglumine (Magnevist, BAY86-4882)

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

DRUG

Moxifloxacin (BAY12-8039)

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

DRUG

Placebo

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

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Completion
2004-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00310596 on ClinicalTrials.gov