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

Bayer

Status and phase: Completed; Phase 3

Conditions: Vascular Diseases

Treatments: Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875); Drug: Gadopentate dimeglumine (Magnevist, BAY86-4882)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00395733

309762 (Other Identifier)

91537

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 vascular 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: 83 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chinese origin
• Known or suspected blood vessel 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: Crossover Assignment

Masking: Single Blind

---

83 participants in 2 patient groups

Gadobutrol, then Gadopentate dimeglumine

Experimental group

Description:

Period 1: Participant received Gadobutrol 1.0 M (iv: intravenous injection), at a dose of 0.2 mL/kg BW, up to 0.3 mL/kg BW if 3 Fields of View (FOVs) to be imaged; Period 2: Participant received Gadopentate 0.5 M (iv), at a dose of 0.4 mL/kg BW, up to 0.6 mL/kg BW if 3 FOVs to be imaged

Treatment:

Drug: Gadopentate dimeglumine (Magnevist, BAY86-4882)

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

Gadopentate, dimeglumine then Gadobutrol

Experimental group

Description:

Period 1: Participant received Gadopentate 0.5 M (iv), at a dose of 0.4 mL/kg BW, up to 0.6 mL/kg BW if 3 FOVs to be imaged; Period 2: Participant received Gadobutrol 1.0 M (iv: intravenous injection), at a dose of 0.2 mL/kg BW, up to 0.3 mL/kg BW if 3 Fields of View (FOVs) to be imaged

Treatment:

Drug: Gadopentate dimeglumine (Magnevist, BAY86-4882)

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