Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Vascular Diseases in Chinese Patients

Vascular Diseases Clinical Trial

Official title:

A Single-blind, Intra-individual, Crossover, Multicenter Study of the Efficacy, Safety and Tolerability of Gadavist (1.0 M) in Comparison With Magnevist (0.5 M) as Contrast Agent in the Enhanced Magnetic Resonance Angiography (MRA) in Chinese Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00395733
• Other study ID #: 91537
• Secondary ID: 309762
• Status: Completed
• Phase: Phase 3
• First received: November 2, 2006
• Last updated: November 25, 2013
• Start date: October 2006
• Est. completion date: October 2007

Study information

• Verified date: November 2013
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if the contrast agent is effective and safe in the Magnetic Resonance Imaging (MRI) of vascular diseases in patients of Chinese origin.

Description:

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Chinese origin

• Known or suspected blood vessel diseases

Exclusion Criteria:

• Pregnancy

• Lactation

• Conditions interfering with MRI

• Allergy to any contrast agent or any drugs

• Participation in other trial

• Require emergency treatment

• Severely impaired liver and kidney functions

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Vascular Diseases

Intervention

Drug:
• Gadobutrol (Gadavist, Gadovist, BAY86-4875)
Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
• Gadopentate dimeglumine (Magnevist, BAY86-4882)
Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Vessel Segments Visualized With Diagnostic Quality	Each arterial segment visualized in magnetic resonance angiography (MRA) enhanced by Gadavist and Magnevist was characterized by the on-site investigators and by three independent blinded readers (reader 1, 2 and 3) according to a five-point scale (none/not assessable, poor, moderate, good, excellent), which takes into consideration intravascular contrast quality as well as vessel border delineation. The number of vessel segments with adequate diagnostic quality, i.e. good or excellent scores, was determined for each MRA image.	20-30 seconds after injection	No
Secondary	Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Investigator	The on-site investigators assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened.	immediately before and 20-30 seconds after injection (precontrast and postcontrast)	No
Secondary	Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 1	Independent blinded reader 1 assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened.	immediately before and 20-30 seconds after injection (precontrast and postcontrast)	No
Secondary	Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 2	Independent blinded reader 2 assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened.	immediately before and 20-30 seconds after injection (precontrast and postcontrast)	No
Secondary	Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 3	Independent blinded reader 3 assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened.	immediately before and 20-30 seconds after injection (precontrast and postcontrast)	No
Secondary	MRA Diagnosis by Investigators	The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis <= 50% (exemption: internal carotid artery: stenosis <= 70%), advanced arteriosclerosis, stenosis >50% but <99% (stenosis 50-99%) (exemption: internal carotid artery >70%), occlusion, and not assessable.	20-30 seconds after injection	No
Secondary	MRA Diagnosis by Blinded Reader 1	The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis <= 50% (exemption: internal carotid artery: stenosis <= 70%), advanced arteriosclerosis, stenosis >50% but <99% (stenosis 50-99%) (exemption: internal carotid artery >70%), occlusion, and not assessable.	20-30 seconds after injection	No
Secondary	MRA Diagnosis by Blinded Reader 2	The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis <= 50% (exemption: internal carotid artery: stenosis <= 70%), advanced arteriosclerosis, stenosis >50% but <99% (stenosis 50-99%) (exemption: internal carotid artery >70%), occlusion, and not assessable.	20-30 seconds after injection	No
Secondary	MRA Diagnosis by Blinded Reader 3	The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis <= 50% (exemption: internal carotid artery: stenosis <= 70%), advanced arteriosclerosis, stenosis >50% but <99% (stenosis 50-99%) (exemption: internal carotid artery >70%), occlusion, and not assessable.	20-30 seconds after injection	No

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