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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 65 years
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

3 sites in 1 country.

About this study

Official title: A Single-blind, Intra-individual, Crossover, Multicenter Study of the Efficacy, Safety and Tolerability of Gadavist (1.0 M) in Comparison With Magnevist (0.5 M) as Contrast Agent in the Enhanced Magnetic Resonance Angiography (MRA) in Chinese Patients

Conditions

Vascular Diseases

Being tested

Gadobutrol (Gadavist, Gadovist, BAY86-4875), Gadopentate dimeglumine (Magnevist, BAY86-4882)

Keywords

Gadovist, Gadavist, MRI Imaging, vascular diseases, Chinese

Medical subject headings

Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

  Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)

• Gadopentate dimeglumine (Magnevist, BAY86-4882)Drug

  Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Number of Vessel Segments Visualized With Diagnostic Quality

   Each arterial segment visualized in magnetic resonance angiography (MRA) enhanced by Gadavist and Magnevist was characterized by the on-site investigators and by three independent blinded readers (reader 1, 2 and 3) according to a five-point scale (none/not assessable, poor, moderate, good, excellent), which takes into consideration intravascular contrast quality as well as vessel border delineation. The number of vessel segments with adequate diagnostic quality, i.e. good or excellent scores, was determined for each MRA image.

   Measured: 20-30 seconds after injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted3 Nov 2006 (estimated)
2. Study startOct 2006
3. Primary completionOct 2007
4. Study completionOct 2007

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Other trials for Vascular DiseasesStudies of the same condition, open and under way.
• More trials run by BayerThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.