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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-04-30

Brief Summary

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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.

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Detailed Description

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The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.

Conditions

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Central Nervous System Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Gadobutrol 0.1 mmol/kg Body Weight (BW) (Gadavist, BAY86-4875)

Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)

Group Type EXPERIMENTAL

Gadobutrol (Gadavist, Gadovist, BAY86-4875)

Intervention Type DRUG

1,0M, intra venous injection at a dose of 0,1 ml/kg BW (= 0,1 mmol Gd/kg BW)

GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)

Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec

Group Type ACTIVE_COMPARATOR

Magnevist

Intervention Type DRUG

0,5M, intra venous injection at a dose of 0,2 ml/kg BW (= 0,1 mmol Gd/kg BW)

Interventions

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Gadobutrol (Gadavist, Gadovist, BAY86-4875)

1,0M, intra venous injection at a dose of 0,1 ml/kg BW (= 0,1 mmol Gd/kg BW)

Intervention Type DRUG

Magnevist

0,5M, intra venous injection at a dose of 0,2 ml/kg BW (= 0,1 mmol Gd/kg BW)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No