EUCTR2008-000500-83-IT进行中（未招募）不适用
A PHASE II EXPLORATORY, ASCENDING DOSE, MULTICENTRE STUDY TOINVESTIGATE THE PHARMACODYNAMICS, PHARMACOKINETICS, SAFETY ANDTOLERABILITY, OF BIM 23A760 IN ACROMEGALIC PATIENTS. - ND
BEAUFOUR IPSEN PHARMA0 个研究点目标入组 24 人开始时间: 2008年9月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
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. The patient has provided written informed consent prior to any
- •study related procedures.
- •2. The patient age is between 18 and 75 years inclusive.
- •3. The patient is male, or a woman aged over 60 who has been
- •post menopausal for at least 5 years. In addition women with a
- •documented infertility (natural or acquired) may be included.
- •4. The patient must agree that, if their partner is at risk of
- •becoming pregnant, they will use an effective method of
- •contraception as defined in the ICH M3 guideline, and this
- •should be continued for two months after the Investigational
- •Medicinal Product (IMP) administration.
- •5. The patient must have documentation supporting the diagnosis
- •of acromegaly, including elevated GH and/or insulin-like
- •growth factor - I (IGF-I) levels.
- •6. The patient has a mean serum GH concentration > 4µg/l during
- •a 5h profile and an IGF-I serum level above normal during the
- •screening period.
- •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. The patient has undergone pituitary surgery within 3 months
- •prior to study entry.
- •2. The patient has undergone radiotherapy anytime prior to study
- •3. It is anticipated that the patient will receive pituitary surgery
- •or radiotherapy during the study.
- •4. The patient has received long acting somatostatin analogues
- •within 6 months prior to study entry.
- •5. The patient has received dopamine agonist or short acting
- •octreotide within 1 month before entering the study.
- •6. The patient has received GH antagonist at anytime prior to
- •study entry.
- •7. The patient is known for not being controlled by somatostatin
- •analogues at anytime prior to study entry.
- •8. The patient has any known uncontrolled cardiovascular
- •disease and/or concomitant medication(s) associated with risk
- •of severe hypotension.
- •9. The patient has any known valvular disease.
- •10. The patient has any known uncontrolled metabolic disease.
- •11. The patient has insulin-treated diabetes or HbA1c > 7.5%.
- •12. The patient has clinically significant hepatic abnormalities
- •and/or AST/ALT > 3 ULN during the screening period.
- •13. The patient has any severe renal or hepatic insufficiency.
- •14. The patient is receiving any Hormone Replacement Therapy
- •15. The patient is receiving neuroleptic antipsychotic/antiemetic
- •16. The patient has abnormal findings during the screening
- •period, any other medical condition(s) or laboratory findings
- •that, in the opinion of the Investigator, might jeopardise the
- •patient?s safety.
- •17. The patient has been treated with any other IMP prior to the
- •first study visit without undergoing a wash-out period of 7
- •times the elimination half-life of the investigational
- •18. The patient has a known hypersensitivity to any of the test
- •materials or related compounds.
- •19. The patient is likely to require treatment during the study with
- •drugs that are not permitted by the study protocol.
- •20. The patient has a history of, or known current, problems with
- •alcohol or drug abuse.
- •21. The patient has any mental condition rendering the patient
- •unable to understand the nature, scope and possible
- •consequences of the study, and/or evidence of an
- •uncooperative attitude.
研究者
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