A Randomized, Open-label, Multicentric Parallel Group Study to Assess the Impact of Supportive Measures on the Drug Adherence of Patients With Essential Hypertension Treated With Valsartan or Valsartan Plus HCTZ for 34 Weeks With or Without Respective Measures

Novartis2 个研究点分布在 2 个国家目标入组 206 人开始时间: 2005年11月1日最近更新: 2017年5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: 206
试验地点: 2
主要终点: Drug adherence in patients (daily proportion of patients taking one tablet of the prescribed hypertensive therapy as prescribed)

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

The purpose of this study is to assess the impact of supportive measures on the drug adherence of patients with 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: Other
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

•Male or female patients >= 18 years
•Females must be either post-menopausal for one year, surgically sterile or using effective contraceptive methods (e.g. barrier method with spermicide, intra-uterine device, hormonal contraceptives).
•Patients with mild essential hypertension: Systolic blood pressure ≥ 140 mmHg and < 170 and/or diastolic blood pressure ≥ 90 mmHg and < 105 mmHg"

排除标准

•Moderate and severe hypertension
•Pregnant or nursing women
•A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and heart failure NYHA II - IV
•Other protocol-defined inclusion/exclusion criteria may apply

结局指标

主要结局

Drug adherence in patients (daily proportion of patients taking one tablet of the prescribed hypertensive therapy as prescribed)

次要结局

HCTZ 12.5 mg.
Compliance and persistence between randomized groups over time.
To assess discrepancies between pill counts, Morisky questionnaire and electronic monitoring to estimate patient adherence to prescribed therapy
To assess the relation between drug exposure and BP reduction.
To assess the relation between drug exposure and the likelihood to switch to valsartan 160 mg plus HCTZ 12.5 mg
To assess the safety and tolerability of valsartan 160 mg and valsartan 160 mg plus

研究者

发起方

Novartis

申办方类型

Industry

研究点 (2)

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