NCT00310596

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jan 2004

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 4, 2006

Completed
Last Updated

December 30, 2014

Status Verified

December 1, 2014

First QC Date

March 31, 2006

Last Update Submit

December 29, 2014

Conditions

Healthy

Keywords

ECG safety

Outcome Measures

Primary Outcomes (1)

  • The primary study variable was heart-rate corrected QT (QTc) interval

    Within 15 min postinjection

Secondary Outcomes (2)

  • Adverse event monitoring, laboratory evaluations

    24 hrs postinjection

  • ECG variables and overall interpretation

    24 hrs postinjection

Study Arms (6)

Arm 1

EXPERIMENTAL
Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Arm 2

EXPERIMENTAL
Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Arm 3

EXPERIMENTAL
Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Arm 4

EXPERIMENTAL
Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Arm 5

ACTIVE COMPARATOR
Drug: Moxifloxacin (BAY12-8039)

Arm 6

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Gadopentetate dimeglumine (Magnevist, BAY86-4882)DRUG

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

Arm 1
Moxifloxacin (BAY12-8039)DRUG

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

Arm 5
PlaceboDRUG

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

Arm 6

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with an electrocardiogram \[ECG\] (normal sinus rhythm \[SR\], QTc \> 450 msec) without clinically significant abnormalities
  • Non-smoker

You may not qualify if:

  • History of cardiovascular disease- Pregnant or nursing- Had any contraindication to moxifloxacin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Miami, Florida, 33181-3405, United States

Location

MeSH Terms

Interventions

Gadolinium DTPAMoxifloxacin

Intervention Hierarchy (Ancestors)

Pentetic AcidPolyaminesAminesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsCoordination ComplexesFluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2006

First Posted

April 4, 2006

Study Start

January 1, 2004

Study Completion

March 1, 2004

Last Updated

December 30, 2014

Record last verified: 2014-12

Locations

US(1)