A Feasibility Study to Evaluate the Safety of Simvastatin in Young Adults Treated for Hodgkin's Disease
N/A
18 Years
35 Years
18 Years
35 Years
Not Enrolling
Both
Carotid Artery Disease
Both
Carotid Artery Disease
Trial Information
A Feasibility Study to Evaluate the Safety of Simvastatin in Young Adults Treated for Hodgkin's Disease
Inclusion Criteria:
- At least three years from completion of treatment for Hodgkin's Disease
- Age 18- 35
- Ability to complete self report questionnaires in either English or Spanish
- Willingness of patient, or parent/guardian if patient less than 18 years of age to
sign consent to participate in study
- Willingness of patient to sign assent if greater than 7 years of age and less than 18
years
Exclusion Criteria:
- Pregnant or breast feeding
- Tanner Stage 1
- Currently taking cyclosporine, niacin, antiretrovirals, macrolide antibiotic, azole
antifungal
- Liver enzymes greater than 1.5 times the upper level of normal
- Creatine Kinase greater than 2 times the upper level of normal
- Use of estrogen containing contraceptive
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
Outcome Measure:
Liver Function Tests and Creatine Kinase
Outcome Time Frame:
every 4 weeks x 3, then at 26 weeks
Safety Issue:
Yes
Principal Investigator
Jennifer Levine, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Columbia Univeristy Medical Center
Authority:
United States: Institutional Review Board
Study ID:
AAAB4447
NCT ID:
NCT00746603
Start Date:
January 2008
Completion Date:
July 2009
Related Keywords:
- Carotid Artery Disease
- Carotid Artery Diseases
- Hodgkin Disease
Name | Location |
|---|---|
| Columbia Univeristy Medical Center | New York, New York 10032 |
