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NCT00908596 · ClinicalTrials.gov registry record · Phase 4
Primovist / Eovist in Renally Impaired Patients
A Phase 4 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 4
- Development phase
- 357
- Enrollment target
NCT00908596 is a Phase 4 study that has completed, run by Bayer. The registered enrollment target is 357 participants.
The verdict
NCT00908596, a Phase 4 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 357 participants
- Enrollment target
Study Summary
Patients with moderate to severe renal impairment scheduled for a magnetic resonance imaging (MRI) scan and injection with a contrast agent, Primovist/Eovist, will be asked to participate. The administration of contrast agents that contain gadolinium such as Primovist/Eovist might increase a potential risk to develop a rare condition called nephrogenic systemic fibrosis (NSF) in patients with renal impairment. This study is to assess the potential risk to develop NSF in patients with renal impairment after the administration of Primovist/Eovist. Patients who are enrolled in this study will receive a Primovist/Eovist enhanced MRI scan which was prescribed by the referring doctor. After the MRI scan the patient will be included in a two year follow-up period to assess if signs or symptoms suggestive of NSF have appeared.
Interventions
- DRUG Gadoxetic acid disodium (Primovist, BAY86-4873)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 357 participants |
| Start Date | 2009-05 |
| Est. Completion | 2013-07 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00908596
The ClinicalTrials.gov registry entry for NCT00908596 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 357 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Gadoxetic acid disodium (Primovist, BAY86-4873) is the first listed.
NCT00908596 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00908596 about?
NCT00908596 is a clinical study titled "Primovist / Eovist in Renally Impaired Patients". Patients with moderate to severe renal impairment scheduled for a magnetic resonance imaging (MRI) scan and injection with a contrast agent, Primovist/Eovist, will be asked to participate. The administration of contrast agents that contain gadolinium such as Primovist/Eovist might increase a potent...
What is the current status of trial NCT00908596?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 357 participants. The study started on 2009-05. Estimated completion is 2013-07.
What interventions are being tested in trial NCT00908596?
The interventions under investigation include: Gadoxetic acid disodium (Primovist, BAY86-4873) (DRUG).
Who is sponsoring clinical trial NCT00908596?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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