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Magnevist (SH L 451A) Intra-individual Dose Comparison Study in Magnetic Resonance Angiography

Primary Purpose

Magnetic Resonance Angiography, Peripheral Vascular Diseases, Peripheral Arterial Diseases

Status

Completed

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

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

About this trial

This is an interventional diagnostic trial for Magnetic Resonance Angiography focused on measuring Magnevist, Magnetic Resonance Angiography, Meglumine gadopentetate, Determination of effective dose in MRA

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm 1

Arm 2

Arm Description

Outcomes

Primary Outcome Measures

Diagnostic ability

Secondary Outcome Measures

Visibility

Diagnostic confidence

Full Information

NCT ID

NCT00652418

First Posted

April 1, 2008

Last Updated

October 10, 2013

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00652418

Brief Title

Magnevist (SH L 451A) Intra-individual Dose Comparison Study in Magnetic Resonance Angiography

Official Title

Evaluation of a Single Intravenous Injection of Magnevist (SH L 451 A) at 0.1 mmol/kg and 0.2 mmol/kg in Contrast-enhanced 3D-Magnetic Resonance Angiography in Patients With Arterial Disease in the Abdominal to Leg Regions in the Ability of Detecting of Vessel Abnormalities

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Completed

Study Start Date

July 2004 (undefined)

Primary Completion Date

October 2004 (Actual)

Study Completion Date

October 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Magnetic Resonance Angiography, Peripheral Vascular Diseases, Peripheral Arterial Diseases

Keywords

Magnevist, Magnetic Resonance Angiography, Meglumine gadopentetate, Determination of effective dose in MRA

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Active Comparator

Arm Title

Arm 2

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

Magnevist at a dose of 0.1 mmol/kg

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

Magnevist at a dose of 0.2 mmol/kg

Primary Outcome Measure Information:

Title

Diagnostic ability

Time Frame

MRI image in blinded read

Secondary Outcome Measure Information:

Title

Visibility

Time Frame

MRI image in blinded read

Title

Diagnostic confidence

Time Frame

MRI image in blinded read

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients who are scheduled to undergo contrast-enhanced 3D-Magnetic Resonance Angiography Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Hirosaki-shi

State/Province

Aomori

ZIP/Postal Code

036-8563

Country

Japan

City

Funai-gun

State/Province

Kyoto

ZIP/Postal Code

629-0197

Country

Japan

City

Hamamatsu-shi

State/Province

Shizuoka

ZIP/Postal Code

431-3192

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

Magnevist (SH L 451A) Intra-individual Dose Comparison Study in Magnetic Resonance Angiography

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