Diurnal variation of exogenous peptides - Gh Puls/Jurgita I

Medical Department M (Endocrinology & Diabetes)0 个研究点目标入组 8 人开始时间: 2010年5月12日最近更新: 2021年8月2日

试验速览

暂无简介。

•1. Informed consent
•2. AGHD male or female subjects as defined in the Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II
•3. Stable GH replacement therapy for at least 3 months
•4. Body Mass Index (BMI, kg/m2) from 18,5 to 35.0 kg/m2, both inclusive
•5. Achieved final height
•6. Age = 18 years
•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

•1. AGHD subjects with active malignancy
•2. Severe cardiac insufficiency classified according to NYHA III-IV
•3. Unstable angina pectoris, acute myocardial infarction (AMI) within the last 12 months
•4. Severe, uncontrolled hypertension: sitting blood pressure (BP) > 180/110 mmHg
•5. HbA1C > 7,5 %
•6. Impaired kidney function: serum creatinine = 150 umol/l according to the hospital lab.
•7. Patients on insulin treatment
•8. Stable pituitary replacement therapy for less than 3 months
•9. Participation in any other clinical trial involving any investigational products within the last three months prior to this trial
•10. Any diseases judged by the investigator that could affect the trial
•11. Women of fertile age, who are pregnant, planning to become pregnant or breast-feeding. Women of fertile age, who are not currently using adequate contraception methods such as: contraceptive pills, intrauterine device (IUD), hysterectomy or sterilization
•12. Known or suspected allergy to the trial product or ingredients of the trial product

发起方

Medical Department M (Endocrinology & Diabetes)