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A Study To Evaluate The Dose Response And Safety Of PHA-794428 In Adults With Growth Hormone Deficiency

Last updated on May 12, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Edegem, , 2650 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Growth Hormone Deficiency
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male and female patients with severe AGHD.

- Hypopituitary patients must be on adequate hormone replacement therapy for at least 6
months.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- AGHD patients with uncontrolled pituitary tumor growth.

- Tumors within 3 mm of the optic chiasm.

- Patients with diabetes mellitus.

NCT00308464
Pfizer
Terminated
A Study To Evaluate The Dose Response And Safety Of PHA-794428 In Adults With Growth Hormone Deficiency

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A Study To Evaluate The Dose Response And Safety Of PHA-794428 In Adults With Growth Hormone Deficiency
A Double Blind Parallel Group Randomised Multiple Dose Study To Evaluate The Pharmacodynamic Response And Safety Of PHA-794428 In Adult Growth Hormone Deficient Patients
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.
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 injection of PHA 794428.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Growth Hormone Deficiency
Drug: PHA-794428
Not Provided
Touraine P, D'Souza GA, Kourides I, Abs R, Barclay P, Xie R, Pico A, Torres-Vela E, Ekman B; GH Lipoatrophy Study Group. Lipoatrophy in GH deficient patients treated with a long-acting pegylated GH. Eur J Endocrinol. 2009 Oct;161(4):533-40. doi: 10.1530/EJE-09-0422. Epub 2009 Aug 4.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
136
December 2007
December 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and female patients with severe AGHD.
  • Hypopituitary patients must be on adequate hormone replacement therapy for at least 6 months.

Exclusion Criteria:

  • AGHD patients with uncontrolled pituitary tumor growth.
  • Tumors within 3 mm of the optic chiasm.
  • Patients with diabetes mellitus.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Czech Republic,   Denmark,   France,   Germany,   Italy,   Netherlands,   Poland,   Slovakia,   Spain,   Sweden,   United Kingdom
 
 
NCT00308464
A6391003
Not Provided
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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