Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Optimark (Gadoversetamide) in Pediatric Patients
Public ClinicalTrials.gov record NCT01092754. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-Label, Multicenter, Phase 4 Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Optimark(R) in Pediatric Patients (2-11 & 12-18 Yrs) Referred for Contrast-Enhanced MRI
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01092754
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 100 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years to 18 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2002
- Primary completion
- Nov 30, 2003
- Completion
- Nov 30, 2003
- Last update posted
- Jul 31, 2017
2002 – 2003
United States locations
- U.S. sites
- 12
- U.S. states
- 10
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arkansas Childrens Hospital | Little Rock | Arkansas | 72201 | — |
| Childrens Hospital and Health Center | San Diego | California | 92101 | — |
| Miami Children's Hospital | Miami | Florida | 33011 | — |
| Children's Mercy Hospitals and clinics | Kansas City | Kansas | 66101 | — |
| Louisiana State University Sciences Center- Shreveport | Shreveport | Louisiana | 71101 | — |
| Childrens Hospital of Michigan | Detroit | Michigan | 48201 | — |
| Cardinal Glennon Childrens Hospital | St Louis | Missouri | 63010 | — |
| St. Louis Childrens Hospital | St Louis | Missouri | 63010 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45202 | — |
| University Hospitals of Cleveland | Cleveland | Ohio | 44102 | — |
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19092 | — |
| Texas Childrens Hospital | Houston | Texas | 77002 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01092754, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 31, 2017 · Synced Sep 12, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01092754 live on ClinicalTrials.gov.