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Trial record 16 of 96 for:    gadobenate dimeglumine

Magnevist (SH L 451A) Intra-individual Dose Comparison Study in Magnetic Resonance Angiography

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00652418
Recruitment Status : Completed
First Posted : April 3, 2008
Last Update Posted : October 14, 2013
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE April 1, 2008
First Posted Date  ICMJE April 3, 2008
Last Update Posted Date October 14, 2013
Study Start Date  ICMJE July 2004
Actual Primary Completion Date October 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2008)
Diagnostic ability [ Time Frame: MRI image in blinded read ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00652418 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2008)
  • Visibility [ Time Frame: MRI image in blinded read ]
  • Diagnostic confidence [ Time Frame: MRI image in blinded read ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Magnevist (SH L 451A) Intra-individual Dose Comparison Study in Magnetic Resonance Angiography
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Magnetic Resonance Angiography
  • Peripheral Vascular Diseases
  • Peripheral Arterial Diseases
Intervention  ICMJE
  • Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)
    Magnevist at a dose of 0.1 mmol/kg
  • Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)
    Magnevist at a dose of 0.2 mmol/kg
Study Arms  ICMJE
  • Active Comparator: Arm 1
    Intervention: Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)
  • Experimental: Arm 2
    Intervention: Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 2, 2008)
12
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2004
Actual Primary Completion Date October 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00652418
Other Study ID Numbers  ICMJE 91396
308612
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP