Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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.

View on ClinicalTrials.gov ↗

View your shortlist →

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

FieldValue
Enrollment Target 3 participants
Start Date 2008-01
Est. Completion 2009-07
Phase NA

Sponsor

Columbia University

958 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.