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

Bayer

Status and phase: Completed; Phase 3

Conditions: Central Nervous System Diseases

Treatments: Drug: Magnevist; Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00395460

309761 (Other Identifier)

91536

Project DE 00562 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 147 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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147 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)

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

Active Comparator group

Description:

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

Treatment:

Drug: Magnevist