NCT01562834已完成4 期
Randomized Cross Over Double Blind Versus Placebo Trial Followed by an Open Phase Studying Effect of Norditropin® on Left Ventricular Mass of Growth Hormone Deficient Adult Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Left ventricular mass measured with ultrasonography
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to assess the effect of somatropin (Norditropin®) replacement therapy on the left ventricular mass of adult patients with a growth hormone deficiency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Childhood or adult onset growth hormone deficiency (GHD)
- •GHD evidenced by two stimulation tests
- •Duration of GHD at least 5 years
- •Other hormone deficiencies associated with growth hormone deficiency
排除标准
- •Pregnancy or pregnancy desired during the suggested duration of the study
- •Personal history of colonic polyp or family history of colonic polyposis
- •Known insulin-dependent or non-insulin-dependent diabetes
- •Cardiovascular disease, left ventricular hypertrophy from other aetiology, recent auricular or ventricular arrhythmia, history of vascularisation by aortocoronary bypass significative mitral or aortic valvular disease, preexcitation syndrome, auriculoventricular conduction delay, bradycardia-tachycardia syndrome, left ventricular mass interfering treatment
- •BMI (Body Mass Index) at least 30
- •Growth hormone treatment during the 24 months prior to inclusion, history of treatment with extractive pituitary growth hormone, allergy or suspected allergy to somatropin therapy
- •Patient who has participated in a different clinical study within the past two months
- •Any condition which, in the opinion of the Investigator or the Scientific Committee, may interfere with successful implementation of the study
- •Notion of breast cancer for the mother or the sister
研究组 & 干预措施
Somatropin
Experimental
干预措施: somatropin (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Left ventricular mass measured with ultrasonography
次要结局
- Quality of life using EQ5D (European Quality of Life 5 Dimensions) scales
- IGF-I (Insulin-Like Growth Factor I) concentration
- Bone mineral density and body composition assessed by DEXA (Dual Energy X-Ray Absorptiometry)
- Ventricular function indices assessed by cardiac ultrasonography
研究者
研究点 (1)
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