EUCTR2009-016722-13-BE进行中（未招募）1 期
A phase III, multicenter, randomized, parallel-group study to assess the efficacy and safety of double-blind pasireotide LAR 40 mg and pasireotide LAR 60 mg versus open-label octreotide LAR or lanreotide ATG in patients with inadequately controlled acromegaly
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 219
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
- •Male and female patients = 18 years of age
- •Patients with written informed consent prior to any study related activity
- •Patients with inadequately controlled acromegaly as defined by
- •a mean GH concentration of a 5-point profile over a 2-hour period > 2.5 µg/L
- •sex- and age adjusted IGF-1 > 1.3 x upper limit of normal (ULN)
- •Patients treated with maximum indicated doses of octreotide LAR or lanreotide ATG for at least 6 months prior to Visit 1 (Screening). The maximum indicated dose for octreotide LAR is 30 mg and for lanreotide ATG is 120 mg
- •Patients with diagnosis of pituitary micro- or macro adenoma. Patients can have been previously submitted to surgery
- •Additional inclusion criteria as per full protocol may apply
- •Are the trial subjects under 18? no
- •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 119
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1.Patients who have received pasireotide (SOM 230) prior to enrolment
- •2. Concomitant treatment with Growth Hormone Receptor (GHR)-
- •antagonist or dopamine agonists unless concomitant treatment was
- •discontinued 8 weeks prior to visit 1 (screening)(8 weeks wash out
- •period). Such patients must have been treated with octreotide LAR 30
- •mg or lanreotide ATG 120 mg monotherapy continuously for a minimum
- •of 6 months prior to starting combination therapy and they should have
- •been inadequately controlled on monotherapy.
- •3. Patients with compression of the optic chiasm causing acute clinically
- •significant visual field defects
- •4. Patients who require a surgical intervention for relief of any sign or
- •symptom associated with tumor compression
- •5. Patients who have received pituitary irradiation within 10 years prior
- •to visit 1 (screening).
- •6. Patients who have undergone major surgery/surgical therapy for any
- •cause within 4 weeks prior to visit 1 (screening).
- •7. Patients who are hypothyroid and not adequately treated with a stable
- •dose of thyroid hormone replacement therapy
- •Other protocol-defined exclusion criteria may apply
研究者
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