EUCTR2009-016722-13-GB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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 198
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
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
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients who have received pasireotide (SOM 230) prior to enrolment
- •Concomitant treatment with GHR-antagonist or dopamine agonists unless concomitant treatment was discontinued 8 weeks prior to Visit 1 (Screening) (8-week wash-out period)
- •Patients with compression of the optic chiasm causing acute clinically significant visual field defects
- •Patients who require a surgical intervention for relief of any sign or symptom associated with tumor compression
- •Patients who have received pituitary irradiation within 10 years prior to Visit 1 (Screening)
- •Patients who have undergone major surgery/surgical therapy for
- •any cause within 4 weeks prior to Visit 1 (Screening)
- •Patients who are hypothyroid and not adequately treated with a stable dose of thyroid hormone replacement therapy
- •Diabetic patients whose blood glucose is poorly controlled as evidenced by HbA1C >8% at Visit 1 (Screening). Patients with a known history of impaired fasting glucose or diabetes mellitus with HbA1c<8% may be included; however, blood glucose and anti diabetic treatment must be monitored closely throughout the trial and adjusted as necessary
- •Patients with known gallbladder or bile duct disease, acute or chronic pancreatitis (patients with asymptomatic cholelithiasis and asymptomatic bile duct dilation can be included)
- •Patients with abnormal coagulation (PT and/or APTT elevated by 30% above normal limits) or patients receiving anticoagulants that affect PT (prothrombin time) or APTT (activated partial thromboplastin time)
- •Patients who have congestive heart failure (NYHA Class III or
- •IV), unstable angina, sustained ventricular tachycardia,
- •ventricular fibrillation, advanced heart block or a history of acute myocardial infarction within the 6 months preceding Visit 1 (Screening)
- •Screening or baseline (predose) QTcF > 450 msec
- •History of syncope or family history of idiopathic sudden death
- •Sustained or clinically significant cardiac arrhythmias
- •Risk factors for Torsades de Pointes such as uncorrected hypokalemia, uncorrected hypomagnesemia, cardiac failure, clinically significant/symptomatic bradycardia or high-grade AV block.
- •Concomitant disease(s) that could prolong the QT interval such as autonomic neuropathy (caused by diabetes or Parkinson’s disease), HIV, cirrhosis, uncontrolled hypothyroidism or cardiac failure
- •Concomitant medication(s) known to increase the QT interval
- •Patients with liver disease or history of liver disease such as cirrhosis, chronic active hepatitis B or C or chronic persistent hepatitis, or patients with ALT and/or AST more than 2 x ULN, total serum bilirubin > 1.5 x ULN, serum albumin < 0.67 x LLN
- •Patients with serum creatinine > 2.0 x ULN
- •Patients with WBC <3 x 109/L; Hgb < 90% LLN; PLT <100 x 109/L
- •Patients with any current or prior medical condition that, in the judgment of the investigator may interfere with the conduct of the study or the evaluation of the study results
- •History of immunocompromise, including a positive HIV test
- •result (ELISA and Western blot). A HIV test will not b
研究者
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