临床试验/NCT00446082

NCT00446082已完成1 期

A Phase I, Multicenter, Open-label, Randomized Study Assessing the Pharmacokinetics, Safety, and Tolerability of Monthly Doses of Pasireotide i.m. LAR Injection in Patients With Acromegaly and Patients With Carcinoid Disease

Novartis Pharmaceuticals5 个研究点分布在 2 个国家目标入组 85 人开始时间: 2006年6月最近更新: 2020年12月21日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Novartis Pharmaceuticals
入组人数: 85
试验地点: 5
主要终点: Determination of the pharmacokinetic profile of single and monthly doses of pasireotide LAR i.m. injection

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study will assess the pharmacokinetic profile and the safety/tolerability profile of single and monthly doses of pasireotide LAR intramuscular (i.m.) injection in patients with acromegaly and patients with carcinoid disease

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

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

未提供

排除标准

未提供

研究组 & 干预措施

SOM230 LAR

Experimental

干预措施: Pasireotide (Drug)

结局指标

主要结局

Determination of the pharmacokinetic profile of single and monthly doses of pasireotide LAR i.m. injection

时间窗: Baseline, D7, D35, D63

in patients with acromegaly and in patients with carcinoid disease

次要结局

To explore the pharmacodynamic profile of single and monthly doses of pasireotide LAR i.m. injection(Baseline, D7, D35, D63)

研究者

发起方

Novartis Pharmaceuticals

申办方类型

Industry

责任方

Sponsor

研究点 (5)

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