NCT00652418

Brief Summary

The objective of the study was to compare the efficacy of Magnevist (SH L 451 A) at doses of 0.1 mmol/kg and 0.2 mmol/kg in contrast-enhanced 3D-Magnetic Resonance Angiography in three regions (abdominal, femoral, and leg regions) for visualization of arteries, evaluating 179 not assessable: caused by contrast media in the evaluation of structural abnormalities. Magnevist (SH L 451 A) was administered intravenously in a crossover design in patients with arterial disease in the abdominal to leg regions. The safety of the 0.2 mmol/kg dose was also assessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2004

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2008

Completed
Last Updated

October 14, 2013

Status Verified

October 1, 2013

Enrollment Period

3 months

First QC Date

April 1, 2008

Last Update Submit

October 10, 2013

Conditions

Magnetic Resonance AngiographyPeripheral Vascular DiseasesPeripheral Arterial Diseases

Keywords

MagnevistMagnetic Resonance AngiographyMeglumine gadopentetateDetermination of effective dose in MRA

Outcome Measures

Primary Outcomes (1)

  • Diagnostic ability

    MRI image in blinded read

Secondary Outcomes (2)

  • Visibility

    MRI image in blinded read

  • Diagnostic confidence

    MRI image in blinded read

Study Arms (2)

Arm 1

ACTIVE COMPARATOR
Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)

Arm 2

EXPERIMENTAL
Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)

Interventions

Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)DRUG

Magnevist at a dose of 0.1 mmol/kg

Arm 1

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are scheduled to undergo contrast-enhanced 3D-Magnetic Resonance Angiography

You may not qualify if:

  • Patients with an ankle brachial pressure index (ABPI) of 0.3 or less
  • Patients with allergy to contrast media
  • Patients with serious hepatic impairment
  • Patients with serious renal impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Hirosaki-shi, Aomori, 036-8563, Japan

Location

Unknown Facility

Funai-gun, Kyoto, 629-0197, Japan

Location

Unknown Facility

Hamamatsu, Shizuoka, 431-3192, Japan

Location

MeSH Terms

Conditions

Peripheral Vascular DiseasesPeripheral Arterial Disease

Interventions

Gadolinium DTPA

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesAtherosclerosisArteriosclerosisArterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Pentetic AcidPolyaminesAminesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsCoordination Complexes

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2008

First Posted

April 3, 2008

Study Start

July 1, 2004

Primary Completion

October 1, 2004

Study Completion

October 1, 2004

Last Updated

October 14, 2013

Record last verified: 2013-10

Locations

JP(3)