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NCT00746603 · ClinicalTrials.gov registry record · NA
Feasibility Study of Simvastatin in Hodgkin's Lymphoma Survivors
A NA study, sponsored by Columbia University.
- Terminated
- Registry status
- NA
- Development phase
- 3
- Enrollment target
NCT00746603 is a NA study that was terminated before completion, run by Columbia University. The registered enrollment target is 3 participants.
The verdict
NCT00746603, a NA study, was terminated before completion, sponsored by Columbia University.
- TERMINATED
- Registry status
- NA
- Development phase
- 3 participants
- Enrollment target
Study Summary
Lay abstract: Study Purpose With contemporary combined modality therapy the expected longterm survival of children and adolescents with Hodgkin's disease (HD) is exceedingly high. Thus, the emphasis for future therapeutic interventions must include attention to the late effects of therapy. The development of cardiovascular disease as a late effect of radiation therapy has been well described and documented. Our recent pilot study of child and young adult HD survivors revealed significant subclinical atherosclerosis as evidenced by increased Carotid Artery Intima Media Thickness (CIMT) compared to controls. The higher CIMT values were positively associated with increasing age, total cholesterol, LDLcholesterol and diastolic BP. This finding was present in children and young adults who had received no or low dose radiation suggesting that chemotherapy or the disease process itself contributes to the development of atherosclerosis and risk for cardiovascular disease. Numerous studies have shown HMG CoA reductase inhibitors ("statins") to be effective in reducing the progression of atherosclerosis in adults. These agents have been studied in children and young adults for over a decade. The primary aim of this study is: To obtain pilot safety data on the use of simvastatin in young adults treated for HD. The secondary aims of this study are: To obtain pilot data on the effect of simvastatin on subclinical carotid artery atherosclerosis as measured by Carotid Artery IMT in young adults treated for HD. To obtain pilot data on the effect of simvastatin on markers of inflammation measured in the serum of young adults treated for HD. To obtain pilot data to serve as the basis for the development of a multicenter randomized study for the use of simvastatin in survivors of HD.
Interventions
- DRUG Simvastatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2008-01 |
| Est. Completion | 2009-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00746603
The ClinicalTrials.gov registry entry for NCT00746603 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Simvastatin is the first listed.
NCT00746603 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00746603 about?
NCT00746603 is a clinical study titled "Feasibility Study of Simvastatin in Hodgkin's Lymphoma Survivors". Lay abstract: Study Purpose With contemporary combined modality therapy the expected longterm survival of children and adolescents with Hodgkin's disease (HD) is exceedingly high. Thus, the emphasis for future therapeutic interventions must include attention to the late effects of therapy. The devel...
What is the current status of trial NCT00746603?
This trial is currently terminated. It is a NA study. The enrollment target is 3 participants. The study started on 2008-01. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00746603?
The interventions under investigation include: Simvastatin (DRUG).
Who is sponsoring clinical trial NCT00746603?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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