Status:
TERMINATED
A Study To Evaluate The Dose Response And Safety Of PHA-794428 In Adults With Growth Hormone Deficiency
Lead Sponsor:
Pfizer
Conditions:
Growth Hormone Deficiency
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to explore the safety, toleration and dose response of PHA-794428 after multiple weekly injections in male and female growth hormone deficient patients.
Detailed Description
The study terminated on 10-Dec-2007. Pfizer's decision to terminate the program was due to cases of injection-site lipoatrophy that were reported in the clinical Phase 2 studies after a single injecti...
Eligibility Criteria
Inclusion
- Male and female patients with severe AGHD.
- Hypopituitary patients must be on adequate hormone replacement therapy for at least 6 months.
Exclusion
- AGHD patients with uncontrolled pituitary tumor growth.
- Tumors within 3 mm of the optic chiasm.
- Patients with diabetes mellitus.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
End Date :
December 1 2007
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT00308464
Start Date
July 1 2006
End Date
December 1 2007
Last Update
May 18 2011
Active Locations (35)
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1
Pfizer Investigational Site
Edegem, Belgium, 2650
2
Pfizer Investigational Site
Ghent, Belgium, 9000
3
Pfizer Investigational Site
Leuven, Belgium, 3000
4
Pfizer Investigational Site
Hradec Králové, Czechia, 500 05