Primovist Regulatory Post Marketing Surveillance (PMS)

NCT ID: NCT00924248

Last Updated: 2012-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

4358 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2011-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of this Post Marketing Surveillance (PMS) is to gain information about safety and efficacy in real practice

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Liver

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Liver MRI

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

Gadoxetic acid disodium (Primovist, BAY86-4873)

Intervention Type DRUG

Patients in daily life clinical practice treatment receiving Primovist according to indication on the label.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Gadoxetic acid disodium (Primovist, BAY86-4873)

Patients in daily life clinical practice treatment receiving Primovist according to indication on the label.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patient who take Primovist for liver MRI

Exclusion Criteria

* Patients who belong to the contraindication on the product label
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Bayer Healthcare AG

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Many Locations, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PR0810KR

Identifier Type: OTHER

Identifier Source: secondary_id

14332

Identifier Type: -

Identifier Source: org_study_id