2型糖尿病患者を対象としたアリキレンの臨床試験（心血管疾患および腎疾患をエンドポイントとする）（コアフェーズおよび延長フェーズ）

基本情報

NCT ID

NCT00549757

ステータス

中止

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

8,606

治験依頼者名

Novartis

概要

The purpose of this study was to determine whether, in patients with type 2 diabetes and pre-existing disease of the heart and the circulatory system and/or the kidney, aliskiren at a target dose of 300 mg once daily (compared to placebo), on top of conventional treatment, reduces death and disease caused by the heart, the circulatory system and the kidney. AMENDMENT 4 RATIONALE (MARCH 2012) : Protocol amendment 4 served to address the data monitoring committee recommendation dated 14 Dec 2011 to discontinue study treatment in all participating patients. It also addressed the subsequent Health Authorities request to implement a 12 month safety follow-up period (actual duration was 9 months in average) post study drug discontinuation.

対象疾患

介入

依頼者（Sponsor）