Observational Study on the Safety and Tolerability of Gad... | NCT00905879

Studies
Observational Study on the Safety and Tolerability of Gadobutrol (Gadovist) Among Filipino Patients in Magnetic Resonance Imaging

NCT00905879

Sponsor

Bayer

Status

Completed

Last Update Posted

Apr 26, 2013Estimated

Enrollment

30Actual

Phase

Not provided

Conditions

Magnetic Resonance Imaging

Interventions

Gadobutrol (Gadovist, BAY86-4875)

Countries

Philippines

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
GV0811PH	Other Identifier	Company Internal

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Not provided

Completion Date

Jan 2011Actual

First Submitted Date

Apr 27, 2009

First Submission Date that Met QC Criteria

May 20, 2009

First Posted Date

May 21, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2013

Last Update Posted Date

Apr 26, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1			Drug: Gadobutrol (Gadovist, BAY86-4875)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gadobutrol (Gadovist, BAY86-4875)	Drug	Patients who will need to undergo contrast enhanced MRI with gadobutrol (Gadovist)	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary outcome measures would be safety and tolerability of Gadovist which would be measured by change in Vital signs before and after the procedure and the occurrence of serious or non-serious adverse events		Up to 1 hour after MRI

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
Magnetic field strength of MRI		During the procedure
Volume of contrast agent used		During the procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years old and above undergoing contrast enhanced cranial or spinal MRI with Gadobutrol (Gadovist)

Exclusion Criteria:

History of hypersensitivity reaction to gadolinium containing contrast material
Hypersensitivity to any of the ingredients of Gadobutrol (Gadovist)
History of hypersensitivity to any other contrast agent
Patients with uncorrected hypokalemia
Pregnant and lactating women
Patients with severe cardiovascular diseases
Patients in whom MRI cannot be performed.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients 18 years old and above who will undergo contrast enhanced MRI with Gadobutrol (Gadovist)

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Intervention Browse Module

MeSH Terms

ID	Term
C090600	gadobutrol

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided