CompletedPhase 3

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

China147 participantsStarted 2006-09

Plain-language summary

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

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Chinese origin, with known or suspected brain or spine 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

What they're measuring

Change in Contrast to Noise Ratio (CNR) Between Pre- and Post-contrast Magnetic Resonance Imaging (MRI) Scan of Central Nervous System (CNS) Lesions

Timeframe: Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)

Trial details

NCT IDNCT00395460

SponsorBayer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-04

Results submitted2011-07-04

View on ClinicalTrials.gov More Central Nervous System Diseases trials