check_circleStudy Completed

Vascular Diseases

Bayer Identifier:

91537

ClinicalTrials.gov Identifier:

NCT00395733

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

Both

Age

18 - 65 Years
  • - Chinese origin
    - Known or suspected blood vessel diseases
  • - 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

Trial summary

Enrollment Goal
83
Trial Dates
October 2006 - October 2007
Phase
Phase 3
Could I Receive a placebo
No
Products
Gadavist/Gadovist (Gadobutrol, BAY86-4875)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Affiliated Ruijin Hosp. Shanghai Jiaotong Univ. Med SchoolShanghai, 200025, China
Completed
Chinese PLA General Hosp.Beijing, 100853, China
Completed
West China Hospital, Sichuan UniversityChengdu, 610041, China

Primary Outcome

  • Number of vessel segments visualized with diagnostic quality
    date_rangeTime Frame:
    20-30 seconds after injection
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Change in diagnostic confidence from pre- to post-contrast Magnetic Resonance Angiography (MRA) by investigator
    date_rangeTime Frame:
    immediately before and 20-30 seconds after injection (precontrast and postcontrast)
    enhanced_encryption
    Safety Issue:
    No
  • Change in diagnostic confidence from pre- to post-contrast MRA by blinded reader 1
    date_rangeTime Frame:
    immediately before and 20-30 seconds after injection (precontrast and postcontrast)
    enhanced_encryption
    Safety Issue:
    No
  • Change in diagnostic confidence from pre- to post-contrast MRA by blinded reader 2
    date_rangeTime Frame:
    immediately before and 20-30 seconds after injection (precontrast and postcontrast)
    enhanced_encryption
    Safety Issue:
    No
  • Change in diagnostic confidence from pre- to post-contrast MRA by blinded reader 3
    date_rangeTime Frame:
    immediately before and 20-30 seconds after injection (precontrast and postcontrast)
    enhanced_encryption
    Safety Issue:
    No
  • MRA diagnosis by investigators
    date_rangeTime Frame:
    20-30 seconds after injection
    enhanced_encryption
    Safety Issue:
    No
  • MRA diagnosis by blinded reader 1
    date_rangeTime Frame:
    20-30 seconds after injection
    enhanced_encryption
    Safety Issue:
    No
  • MRA diagnosis by blinded reader 2
    date_rangeTime Frame:
    20-30 seconds after injection
    enhanced_encryption
    Safety Issue:
    No
  • MRA diagnosis by blinded reader 3
    date_rangeTime Frame:
    20-30 seconds after injection
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Diagnostic
Allocation
Randomized
Blinding
Single Blind
Assignment
Crossover Assignment
Trial Arms
2

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.