NCT00698646已完成4 期
A 16 Week Multi-center, Randomized, Double-blind Study to Evaluate Efficacy and Safety of Valsartan/Hydrochlorothiazide (HCTZ) Combination Therapy Compared to Patients Initiated With Valsartan Monotherapy or Hydrochlorothiazide (HCTZ) Monotherapy in Very Elderly Patients With Essential Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 384
- 试验地点
- 3
- 主要终点
- Change From Baseline to Week 4 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)
研究概览
简要总结
The purpose of the study is to evaluate the safety and efficacy of initial treatment therapy with valsartan/hydrochlorothiazide (HCTZ) versus the initial treatment therapy with monotherapies (valsartan or HCTZ) in the very elderly patients (greater than or equal to 70 years) with stage 1 or 2 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 70 years or older.
- •Patients with hypertension prior to being randomized into study.
- •Patients must have an office cuff MSSBP ≥ 140 and ≤ 200 mmHg systolic.
- •Have the ability to communicate and comply with all study requirements.
- •Provide written informed consent to participate in the study prior to any screening or study procedures.
排除标准
- •Use of other investigational drugs within 30 days of enrollment.
- •History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
- •Office blood pressure measured by office machine cuff with a mean of (3) MSDBP ≥ 120 mmHg at anytime during the screening / washout period.
- •Patients taking 3 or more antihypertensive drugs and MSSBP ≥ 160 mmHg at the time of Visit
- •Other protocol-defined exclusion criteria may apply
研究组 & 干预措施
Valsartan
Active Comparator
(patients initiated on valsartan)
干预措施: Valsartan (Drug)
HCTZ
Active Comparator
(patients initiated on HCTZ)
干预措施: HCTZ (Drug)
Valsartan + HCTZ
Experimental
(patients initiated on Valsartan+HCTZ)
干预措施: Valsartan + HCTZ (Drug)
结局指标
主要结局
Change From Baseline to Week 4 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)
时间窗: Baseline and Week 4
次要结局
- Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)(Baseline and Weeks 4, 8, 12 and 16)
- Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)(Baseline and Weeks 8, 12, and 16)
- Cumulative Percentage of Patients Achieving the Blood Pressure Control of < 140/90 mmHg(Weeks 4, 8, 12 and 16)
- Cumulative Percentage of Patients Achieving Blood Pressure Goal (MSSBP < 140 mmHg)(Weeks 4, 8, 12 and 16)
- Time in Weeks to Achieving the First Treatment Success (Defined as the Time of the First Achievement of the Target Blood Pressure Goal [MSSBP/MSDBP <140/90 mmHg])(During 16 weeks)
研究者
研究点 (3)
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