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

NCT00395733 | Completed Phase 3 Results

• 2 other identifiers: 91537309762
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Vascular Diseases

Keywords

Gadovist; Gadavist; MRI Imaging; vascular diseases; Chinese

Outcome Measures

Primary Outcomes (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.

  20-30 seconds after injection

Secondary Outcomes (8)

• Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Investigator

  immediately before and 20-30 seconds after injection (precontrast and postcontrast)

• Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 1

  immediately before and 20-30 seconds after injection (precontrast and postcontrast)

• Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 2

  immediately before and 20-30 seconds after injection (precontrast and postcontrast)

• Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 3

  immediately before and 20-30 seconds after injection (precontrast and postcontrast)

• MRA Diagnosis by Investigators

  20-30 seconds after injection

Study Arms (2)

Gadobutrol, then Gadopentate dimeglumine

EXPERIMENTAL

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

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

Gadopentate, dimeglumine then Gadobutrol

EXPERIMENTAL

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

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

Interventions

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)

Gadobutrol, then Gadopentate dimeglumine; Gadopentate, dimeglumine then Gadobutrol

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)

Gadobutrol, then Gadopentate dimeglumine; Gadopentate, dimeglumine then Gadobutrol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chinese origin
• Known or suspected blood vessel diseases

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (3)

Unknown Facility

Chengdu, Sichuan, 610041, China

Location

Unknown Facility

Beijing, 100853, China

Location

Unknown Facility

Shanghai, 200025, China

Location

MeSH Terms

Conditions

Vascular Diseases

Interventions

gadobutrol; Gadolinium DTPA

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pentetic Acid; Polyamines; Amines; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Coordination Complexes

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: BAYER

clinical-trials-contact@bayerhealthcare.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2006
• First Posted: November 3, 2006
• Study Start: October 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: December 18, 2013
• Results First Posted: August 3, 2011

Record last verified: 2013-11

Locations

CN (3)