NCT00338936已完成3 期
A 52-week Extension to the Factorial Study to Evaluate the Efficacy and Safety of VAH631 (Valsartan and Hydrochlorothiazide Combined) and Alone in Essential Hypertensive Patients - Long Term Study of VAH631 in Patients With Essential Hypertension (Extension From B1303 Study) -
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 362
- 主要终点
- Assessment of safety through reporting of adverse events, serious adverse events and deaths over 52 weeks.
研究概览
简要总结
This study is designed to provide long-term safety and efficacy data for the combination doses of VAH (VAL/ HCTZ) 40/6.25mg and 80/12.5mg in essential hypertensive patients. The 350 patients (approximately) who have successfully finished the core trial CVAH631B1303 and signed consent for the extension will be enrolled into this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who successfully complete the core study (Protocol 1303)
- •Outpatients
排除标准
- •Presence of crucial protocol violation in Protocol 1303
- •Patients who experienced any adverse events considered serious and drug related in Protocol 1303.
结局指标
主要结局
Assessment of safety through reporting of adverse events, serious adverse events and deaths over 52 weeks.
次要结局
- Change from baseline in average sitting diastolic blood pressure after 52 weeks
- Change from baseline in average sitting systolic blood pressure after 52 weeks
- Change from baseline in average standing diastolic blood pressure after 52 weeks
- Change from baseline in average standing systolic blood pressure after 52 weeks
- Laboratory abnormalities after 52 weeks
研究者
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