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.
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