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 - N/A

• Conditions: Adult Growth Hormone Deficiency; MedDRA version: 8.1Level: LLTClassification code 10056438

• Registration Number: EUCTR2005-005587-82-DK
• Lead Sponsor: Pfizer Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

1. Male and female patients between the ages of 25-60 yrs with severe AGHD as defined by GRS Guidelines (3). Patients may be included if they had idiopathic severe GHD in childhood, which is still present on re-testing, or if they have isolated GHD with evidence of hypothalamic/pituitary pathology.

2. Hypopituitary patients must be on adequate hormone replacement therapy for at least 6 months. Patients must be demonstrated to have adequate cortisol reserve or be on adequate glucocorticoid replacement therapy.

3. GH treated patients will have a minimum of 3 weeks washout (and not longer than 4 weeks) prior to dosing.
Are the trial subjects under 18?
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. AGHD patients with uncontrolled pituitary tumor growth. Patients with pituitary tumors must have demonstrated stable neuroimaging within 12 months of the screening visit.

2. Tumors within 3 mm of the optic chiasm. Patients with residual suprasellar disease, must be scanned within 3 months of the screening visit.

3. Serum ALT and/or AST = 1.5 times the upper limit of normal range (ULN), or clinically significant hepatic disease.

4. Patients with diabetes mellitus. Impaired glucose tolerance without drug treatment is permissible.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Main objectives: <br><br>To explore the safety, toleration and humoral response of PHA-794428 after multiple weekly injections in AGHD patients.<br><br>To explore the dose response relationship of PHA-794428 after multiple weekly subcutaneous injections in AGHD patients.<br><br>To explore the PK/PD relationships with PHA-794428 after single and multiple injections.<br>;Secondary Objective: ;Primary end point(s): 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.