NCT00068029已完成4 期
A Randomized, Parallel Group, Three-Arm Study To Evaluate Treatment With A Combination Of Pegvisomant Plus Sandostatin Lar, Pegvisomant (Alone), And Sandostatin Lar (Alone) In Patients With Acromegaly
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 75
- 试验地点
- 33
- 主要终点
- Number of subjects experiencing treatment-emergent adverse events across the duration fo the study
研究概览
简要总结
The purpose of this study is to compare the safety and tolerability of combination therapy with Sandostatin LAR plus Pegvisomant to that of Sandostatin LAR alone or Pegvisomant alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of acromegaly
- •Received previous radiation and/or surgical treatment for their GH (Growth Hormone) producing pituitary adenoma and have required medical therapy due to failure to normalize GH (Growth Hormone) and/or IGF-I as a result of their primary treatment
- •Patients that been receiving Sandostatin LAR for a minimum of 6 months prior to enrollment
排除标准
- •Presence of other conditions that may result in abnormal GH (Growth Hormone) and/or IGF-I concentrations
- •Patients on current medical therapy other than Sandostatin LAR
- •AST/ALT >= 3xULN (upper limits of normal)
- •Pituitary adenoma within 3mm of optic chiasm confirmed by recent MRI
- •Visual field defects (except post-surgical stable residual defects)
- •Unable to self administer drug
- •Radiotherapy within 12 months of entering the study
结局指标
主要结局
Number of subjects experiencing treatment-emergent adverse events across the duration fo the study
次要结局
- Percentage of patients with normalization of IGF-I, at Week 40, in the two randomized groups (Sandostatin LAR plus pegvisomant and pegvisomant alone). Normal IGF-I is defined as a value within the normal reference range for age for the study specific
研究者
研究点 (33)
Loading locations...
相似试验
已完成
2 期
Atacicept in Combination With Rituximab in Subjects With Rheumatoid Arthritis (August III)Rheumatoid ArthritisNCT00664521Merck KGaA, Darmstadt, Germany27
已完成
2 期
Study of Safety, Tolerability, and Efficacy of a Combination Treatment of LJN452 and CVC in Adult Patients With NASH and Liver FibrosisNon-alcoholic Steatohepatitis (NASH)NCT03517540Novartis Pharmaceuticals193
Unknown
3 期
Phase III Trial to Evaluate the Efficacy and Safety of Gemigliptin 50mg qd Added to Ongoing Glimepiride as Fix-dose Combination in Patients With Type 2 DiabetesType 2 Diabetes MellitusNCT02089126LG Life Sciences230
已完成
2 期
Study to Evaluate the Efficacy and Safety of K-877-ER and CSG452 in Participants With NASH With Liver FibrosisNASHNCT05327127Kowa Research Institute, Inc.228
已完成
2 期
Lotemax® Gel 0.5% and Restasis 0.05% in Participants With Mild or Moderate Keratoconjunctivitis Sicca (Dry Eye Disease)Keratoconjunctivitis SiccaNCT01817582Bausch & Lomb Incorporated102