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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00308464 |
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Date of registration:
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27/03/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study To Evaluate The Dose Response And Safety Of PHA-794428 In Adults With Growth Hormone Deficiency
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Scientific title:
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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 |
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Date of first enrolment:
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July 2006 |
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Target sample size:
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136 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00308464 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Belgium
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Czech Republic
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Denmark
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France
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Germany
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Italy
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Netherlands
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Poland
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Slovakia
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Spain
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Sweden
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United Kingdom
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Growth Hormone Deficiency
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Intervention(s)
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Drug: PHA-794428
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Primary Outcome(s)
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Responder status at visits 9 (week 4) and 14 (week 7), where responder is defined as a patient who has achieved an IGF-1 level above the mid-point of the age-related normal range.
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Secondary Outcome(s)
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Change in PD and glycemic control
[Time Frame: At weeks 4 and 7]
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ALT, AST greater than 3.0 times ULN at any visit
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Anti-hGH and anti PHA-794428 antibody production
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Change in body weight
[Time Frame: At week 4 and follow-up]
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Change in PK concentrations.
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Injection site reactions
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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