check_circleStudy Completed
Vascular Diseases
Bayer Identifier:
91537
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Efficacy and safety study to evaluate Gadavist (Gadobutrol) as contrast agent in Magnetic Resonance Imaging (MRI) of vascular diseases in Chinese patients
Trial purpose
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.
Key Participants Requirements
Sex
BothAge
18 - 65 YearsTrial summary
Enrollment Goal
83Trial Dates
October 2006 - October 2007Phase
Phase 3Could I Receive a placebo
NoProducts
Gadavist/Gadovist (Gadobutrol, BAY86-4875)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Affiliated Ruijin Hosp. Shanghai Jiaotong Univ. Med School | Shanghai, 200025, China |
Completed | Chinese PLA General Hosp. | Beijing, 100853, China |
Completed | West China Hospital, Sichuan University | Chengdu, 610041, China |
Primary Outcome
- Number of vessel segments visualized with diagnostic qualitydate_rangeTime Frame:20-30 seconds after injectionenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Change in diagnostic confidence from pre- to post-contrast Magnetic Resonance Angiography (MRA) by investigatordate_rangeTime Frame:immediately before and 20-30 seconds after injection (precontrast and postcontrast)enhanced_encryptionNoSafety Issue:
- Change in diagnostic confidence from pre- to post-contrast MRA by blinded reader 1date_rangeTime Frame:immediately before and 20-30 seconds after injection (precontrast and postcontrast)enhanced_encryptionNoSafety Issue:
- Change in diagnostic confidence from pre- to post-contrast MRA by blinded reader 2date_rangeTime Frame:immediately before and 20-30 seconds after injection (precontrast and postcontrast)enhanced_encryptionNoSafety Issue:
- Change in diagnostic confidence from pre- to post-contrast MRA by blinded reader 3date_rangeTime Frame:immediately before and 20-30 seconds after injection (precontrast and postcontrast)enhanced_encryptionNoSafety Issue:
- MRA diagnosis by investigatorsdate_rangeTime Frame:20-30 seconds after injectionenhanced_encryptionNoSafety Issue:
- MRA diagnosis by blinded reader 1date_rangeTime Frame:20-30 seconds after injectionenhanced_encryptionNoSafety Issue:
- MRA diagnosis by blinded reader 2date_rangeTime Frame:20-30 seconds after injectionenhanced_encryptionNoSafety Issue:
- MRA diagnosis by blinded reader 3date_rangeTime Frame:20-30 seconds after injectionenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
DiagnosticAllocation
RandomizedBlinding
Single BlindAssignment
Crossover AssignmentTrial Arms
2