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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Gadolinium DTPA
Gadobenic acid
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014