A Randomized, Double-blind, Placebo and Active-controlled, Multicenter, Parallel-group Study Comparing SPP100 (Aliskiren) 150mg to Placebo and to Losartan 50mg to Evaluate Efficacy, Safety and Pharmacokinetics in Patients With Mild to Moderate Essential Hypertension

Novartis1 个研究点分布在 1 个国家目标入组 768 人开始时间: 2006年6月1日最近更新: 2016年11月18日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Novartis
入组人数: 768
试验地点: 1
主要终点: Mean sitting diastolic blood pressure (msDBP) lowering from baseline to the study end to placebo and losartan

研究概览研究设计入排标准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

Assessing efficacy, safety and pharmacokinetics in patients with mild to moderate essential hypertension

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double

入排标准

年龄范围: 20 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Age: 20 - 75 years old
•Gender: Male or female
•Status: Outpatients
•Mild to moderate essential hypertension

排除标准

•Pregnant women, lactating mothers, women suspected of being pregnant, or women who wish to be pregnant
•Patients with msSBP >==180 mmHg and/or msDBP >=110 mmHg at Visit 1, 2 or 3
•Patients with or suspected of having secondary hypertension (due to aortic coarctation, primary aldosteronism, etc.)
•Patients suspected of having malignant hypertension
•Other protocol-defined inclusion/exclusion criteria may apply

结局指标

主要结局

Mean sitting diastolic blood pressure (msDBP) lowering from baseline to the study end to placebo and losartan

次要结局

Mean sitting systolic pressure (msSBP) lowering from baseline to the study end to placebo and losartan
Successful response; msDBP <90mmHg and/or a reduction of msDBP ≥ 10mmHg
Control rate; msDBP <90mmHg and msSBP<140mmHg
The pharmacokinetics / pharmacodynamics
Safety and tolerability

研究者

发起方

Novartis

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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