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临床试验/NCT00858143
NCT00858143已完成不适用

German Non Interventional Study For Patients Treated With Somavert®

Pfizer0 个研究点目标入组 311 人开始时间: 2004年1月最近更新:
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适应症

试验速览

阶段
不适用
状态
已完成
发起方
Pfizer
入组人数
311
主要终点
Serious Adverse Events (SAE) and Adverse Events (AE)
研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

This open-label, national, prospective, observational, non-interventional, multi-center, post marketing surveillance study was performed in order to examine the efficacy and safety of Somavert® in treatment of subjects with acromegaly and its effects on acromegaly related co-morbidities.

详细描述

Non probability samples

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Subjects with diagnosed acromegaly who were already being treated with Somavert® or were to start treatment with Somavert® were included in the study.

排除标准

  • •Subjects treated with an investigational drug for treatment of acromegaly.
  • •Subjects with symptoms such visual field loss, cranial nerve palsies or intracranial hypertension, indicating need for surgery.
  • •Women who were pregnant or lactating.

结局指标

主要结局

Serious Adverse Events (SAE) and Adverse Events (AE)

时间窗: Baseline up to 5 years

Long term safety of Somavert in treatment of patients with acromegaly

次要结局

  • IGF-I Values Above Normal Range(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5))
  • Change From Baseline Glucose (Fasting)(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5))
  • Glucose Values Below Normal Range (Fasting)(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5))
  • Insulin-Like Growth Factor I (IGF-I) Values Above Normal Range in Diabetic Patients(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5))
  • HbA 1c Values Below Normal Range in Diabetic Patients(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5))
  • HbA 1c Values Above Normal Range in Diabetic Patients(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5))
  • Change From Baseline Hemoglobin A 1c (HbA 1c) in Diabetic Patients(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5))
  • HbA 1c Values Within Normal Range in Diabetic Patients(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5))
  • Glucose Values Above Normal Range in Diabetic Patients (Fasting)(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5))
  • Change in Numbness or Tingling of Limbs Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4))
  • Change From Baseline for Diastolic Blood Pressure (BP)(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5))
  • Change From Baseline Insulin-like Growth Factor I (IGF-I)(Baseline, Follow-up 1 (FUP 1) at ~6 months , Follow-up 2 (FUP 2) at ~12 months, Follow-up 3 (FUP 3) at ~ 24 months, Follow-up 4 (FUP 4) at ~ 36 months, Follow-up 5 (FUP 5) at ~ 48 months, Follow-up 6 (FUP 6)at ~60 months)
  • Change From Baseline Hemoglobin A 1c (HbA 1c)(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5))
  • HbA 1c Values Below Normal Range(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5), 60 months (FUP 6))
  • HbA 1c Values Above Normal Range(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5))
  • Glucose Values Within Normal Range (Fasting)(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5))
  • Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Within Normal Range(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5))
  • Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Above Normal Range(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5))
  • IGF-I Absolute Values(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5))
  • Absolute Glucose Values (Fasting)(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5))
  • Absolute Values Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5))
  • Absolute Values for Hemoglobin A 1c (HbA 1c) in Diabetic Patients(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5))
  • Absolute Glucose Values in Diabetic Patients (Fasting)(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5))
  • Glucose Values Within Normal Range in Diabetic Patients (Fasting)(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5))
  • IGF-I Values Within Normal Range(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5))
  • HbA 1c Values Within Normal Range(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5))
  • Change From Baseline Glucose <(2 Hour Oral Glucose Tolerance Test (2h oGTT)>(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3))
  • Glucose Values Above Normal Range (Fasting)(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5))
  • Absolute Glucose Values (2h oGTT)(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5))
  • Absolute Hemoglobin A 1c (HbA 1c) Values(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5))
  • Change From Baseline Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5))
  • Insulin-Like Growth Factor I (IGF-I) Values Within Normal Range in Diabetic Patients(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5))
  • Change in Fatigue Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4))
  • Glucose Change From Baseline in Diabetic Patients (Fasting)(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5))
  • Change in Headache Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4))
  • Change in Joint Pain Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4))
  • Change in Soft Tissue Swelling Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4))
  • Mean Change From Baseline for Body Weight(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5))
  • Adjusted Mean Dose of Somavert® Needed to Normalize the IGF-I Concentration in the Safety Population(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5))
  • Change in Excessive Sweating Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4))
  • Change From Baseline for Systolic Blood Pressure (BP)(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5))
  • Change in General Physical Condition Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4))
  • Change in Total PASQ Score Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4))
  • Change From Baseline in Ring Size(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5))
  • Adjusted Mean Dose of Somavert® Needed to Normalize the IGF-I Concentration in the ITT Population(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5))

研究者

发起方
Pfizer
申办方类型
Industry

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