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NCT01092754 · ClinicalTrials.gov registry record · Phase 4
Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Optimark (Gadoversetamide) in Pediatric Patients
A Phase 4 study, sponsored by Guerbet.
- Completed
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
NCT01092754 is a Phase 4 study that has completed, run by Guerbet. The registered enrollment target is 100 participants.
The verdict
NCT01092754, a Phase 4 study, has completed, sponsored by Guerbet.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
Study Summary
The objective of this study is to characterize the safety, efficacy and pharmacokinetic profiles of Optimark at the standard clinical dose of 0.1 mmol/kg in the pediatric patient population.
Interventions
- PROCEDURE MRI
- DRUG Gadoversetamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2002-05 |
| Est. Completion | 2003-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01092754
The ClinicalTrials.gov registry entry for NCT01092754 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Guerbet, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which MRI is the first listed.
NCT01092754 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01092754 about?
NCT01092754 is a clinical study titled "Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Optimark (Gadoversetamide) in Pediatric Patients". The objective of this study is to characterize the safety, efficacy and pharmacokinetic profiles of Optimark at the standard clinical dose of 0.1 mmol/kg in the pediatric patient population.
What is the current status of trial NCT01092754?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2002-05. Estimated completion is 2003-12.
What interventions are being tested in trial NCT01092754?
The interventions under investigation include: MRI (PROCEDURE), Gadoversetamide (DRUG).
Who is sponsoring clinical trial NCT01092754?
This trial is sponsored by Guerbet, which has 15 total clinical trials registered on ClinicalTrials.gov.
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