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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00652418
First received: April 1, 2008
Last updated: October 10, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Magnetic Resonance Angiography
Peripheral Vascular Diseases
Peripheral Arterial Diseases
Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Diagnostic ability [ Time Frame: MRI image in blinded read ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visibility [ Time Frame: MRI image in blinded read ] [ Designated as safety issue: No ]
  • Diagnostic confidence [ Time Frame: MRI image in blinded read ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: July 2004
Study Completion Date: October 2004
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1 Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)
Magnevist at a dose of 0.1 mmol/kg
Experimental: Arm 2 Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)
Magnevist at a dose of 0.2 mmol/kg

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00652418

Locations
Japan
Hirosaki-shi, Aomori, Japan, 036-8563
Funai-gun, Kyoto, Japan, 629-0197
Hamamatsu-shi, Shizuoka, Japan, 431-3192
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00652418     History of Changes
Other Study ID Numbers: 91396, 308612
Study First Received: April 1, 2008
Last Updated: October 10, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Bayer:
Magnevist
Magnetic Resonance Angiography
Meglumine gadopentetate
Determination of effective dose in MRA

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on April 22, 2014