EUCTR2005-005587-82-DK进行中（未招募）不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 136
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
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