EUCTR2007-001972-36-PT进行中（未招募）不适用
A multicenter, randomized, blinded study to assess the safety and efficacy of pasireotide LAR vs. octreotide LAR in patients with active acromegaly.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 330
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 or female patients of at least 18 years of age
- •2. Patients with active acromegaly demonstrated by
- •a lack of suppression of GH nadir to <1 µg/L after an oral tolerance test with 75 g of glucose (not applicable for diabetic patients) or a mean GH concentration of a 5-point profile within a 2 hour time period of > 5 µg/L
- •elevated circulating IGF-1 concentration (age and sex adjusted)
- •3. a) Patients who have undergone a first surgery, butare still medical treatment naïve or b) de-novo patients who present with a visible adenoma on MRI and who refuse pituitary surgery or for whom pituitary surgery is contraindicated
- •4. Patients with a known history of impaired fasting glucose or diabetes mellitus may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessary (see Section 6.6.3)
- •5. Patients for whom written informed consent to participate in the study has been obtained. prior to any study related activity
- •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
- •1. Patients who are being or were treated with octreotide, lanreotide or dopamine agonists
- •2. Patients who are being or were treated with GH antagonists
- •3. De-novo patients having a pituitary adenoma not visible on MRI
- •4. Patients who have received pasireotide (SOM 230) prior to randomization
- •5. Patients with compression of the optic chiasm causing any visual field defect
- •6. Patients who require a surgical intervention for relief of any sign or symptom associated with tumor compression
- •7. Patients who have undergone major surgery/surgical therapy for any cause within 1 month of visit 1
- •8. Patients who have received radiotherapy (except for pituitary irradiation) for any reason within 4 weeks of visit 1 must have recovered from any side effect of radiotherapy
- •9. Patients who have received pituitary irradiation within the last ten years prior to visit 1
- •10. Patients who are hypothyroid and not adequately treated with stable doses of thyroid hormone replacement therapy
- •11. Diabetic patients on antidiabetic medications whose fasting blood glucose is poorly controlled as evidenced by HbA1c >8%
- •12. Patients with symptomatic cholelithiasis
- •13. 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)
- •14. Patients who have congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation, clinically significant
- •bradycardia, advanced heart block or a history of acute myocardial infarction within the six months preceding enrollment
- •15. Patients with risk factors for torsade de pointes, i.e. patients with a baseline QTc > 450 ms, hypokalemia, hypomagnesemia, hypocalcemia, family history of long QT syndrome, and taking concomitant medications known to prolong QT interval
- •16. Patients with confirmed central hypothyroidism, central hypoadrenalism, central
- •hypogonadism and diabetes insipidus, unless they are adequately treated with stable doses of hormone replacement therapy for a minimum of three months prior to study entry (first dose of study medication)
- •17. Patients with liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis, or patients with ALT and/or AST more than 2 x ULN, serum creatinine > 2.0 x ULN, serum bilirubin > 2 x ULN, serum albumin < 0.67 x LLN
- •18. Patients with WBC <3 x 109/L; Hgb < LLN; PLT <100 x 109/L
- •19. Patients who have any current or prior medical condition that may interfere with the conduct of the study or the evaluation of its results in the opinion of the Investigator or the Sponsor’s Medical Monitor
- •20. Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control. Female patients must use barrier contraception with condoms. If oral contraception is used in addition to condoms, the patient must have been practicing this method for at least two months prior to the enrollment and must agree to continue the oral contraceptive throughout the course of the study and for 3 months after the study has ended. Male patients who are sexually active
- •are required to use condoms during the study and for three month afterwards as a
- •precautionary measure (available data do not suggest any increased reproductive risk with the study drugs)
- •21. History of immunocompromise, including a positive HIV test result (ELISA
研究者
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