This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The safety and efficacy of combination therapy with Sandostatin LAR plus pegvisomant will be compared with that of Sandostatin LAR alone or pegvisomant alone in patients with active acromegaly. The primary endpoint is to determine the number of patients in each group who experience adverse events and the nature of the adverse events. Secondary endpoints of efficacy include the number of patients who achieve a normal serum IGF-1 concentration, clinical improvement (ring size, acromegaly signs and symptom scale) and quality of life scores. This is a multi-center, open-label, parallel group, partially randomized, pegvisomant dose optimization study.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
2M01RR000847-33
Application #
7374430
Study Section
Special Emphasis Panel (ZRR1-CR-8 (01))
Project Start
2006-05-05
Project End
2007-02-28
Budget Start
2006-05-05
Budget End
2007-02-28
Support Year
33
Fiscal Year
2006
Total Cost
$10,723
Indirect Cost
Name
University of Virginia
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
065391526
City
Charlottesville
State
VA
Country
United States
Zip Code
22904
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