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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00395733 |
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Date of registration:
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02/11/2006 |
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Primary sponsor: |
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Public title:
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Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Vascular Diseases in Chinese Patients
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Scientific title:
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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 |
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Date of first enrolment:
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October 2006 |
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Target sample size:
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83 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00395733 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
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Countries of recruitment
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China
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Contacts
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Name:
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Bayer Study Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bayer |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Vascular Diseases
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Intervention(s)
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Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)
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Drug: Gadopentate dimeglumine (Magnevist, BAY86-4882)
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Primary Outcome(s)
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Number of Vessel Segments Visualized With Diagnostic Quality
[Time Frame: 20-30 seconds after injection]
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Secondary Outcome(s)
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Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 1
[Time Frame: immediately before and 20-30 seconds after injection (precontrast and postcontrast)]
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Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 2
[Time Frame: immediately before and 20-30 seconds after injection (precontrast and postcontrast)]
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Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 3
[Time Frame: immediately before and 20-30 seconds after injection (precontrast and postcontrast)]
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Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Investigator
[Time Frame: immediately before and 20-30 seconds after injection (precontrast and postcontrast)]
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MRA Diagnosis by Blinded Reader 1
[Time Frame: 20-30 seconds after injection]
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MRA Diagnosis by Blinded Reader 2
[Time Frame: 20-30 seconds after injection]
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MRA Diagnosis by Blinded Reader 3
[Time Frame: 20-30 seconds after injection]
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MRA Diagnosis by Investigators
[Time Frame: 20-30 seconds after injection]
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Secondary ID(s)
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309762
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91537
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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