NCT00760266已完成4 期
An 8-week Randomized, Double-blind, Parallel-group, Multi-center, Active-controlled Dose Escalation Study to Evaluate the Efficacy and Safety of Aliskiren HCTZ (300/25 mg) Compared to HCTZ (25 mg) in Older Patients With Stage 2 Systolic 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
- 发起方
- Novartis
- 入组人数
- 451
- 试验地点
- 1
- 主要终点
- Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 4
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of initial use of a fixed dose combination of aliskiren Hydrochlorothiazide (HCTZ) compared to Hydrochlorothiazide in older population with Stage 2 systolic 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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female outpatients, ≥ 55 years old
- •Patients with essential hypertension
- •Prior to randomization: Patients must have an office cuff mean sitting Systolic Blood Pressure ≥ 160 mm Hg and < 200 mm Hg
- •Patients who are eligible and able to participate in the study, and who are willing to give informed consent before any assessment is performed
排除标准
- •Office blood pressure measured by cuff (msSBP ≥ 200 mm Hg and/or msDBP ≥ 110 mm Hg) at Visits 1-5
- •History or evidence of a secondary hypertension of any etiology (e.g., uncorrected renal artery stenosis, pheochromocytoma).
- •History of hypertensive encephalopathy or heart failure (New York Heart Association [NYHA] Class II-IV)
- •Cerebrovascular accident, transient ischemic cerebral attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI) within 1 year prior to Visit 1
- •Serum sodium less than the lower limit of normal, serum potassium < 3.5 mEq/L (corresponding to 3.5 mmol/L) or ≥ 5.3 mEq/L (corresponding to 5.3 mmol/L), or dehydration at Visit
- •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL)
- •Use of other investigational drugs within 30 days of enrollment.
- •Other exclusions may apply.
研究组 & 干预措施
Aliskiren/HCTZ 300/25 mg
Experimental
干预措施: Aliskiren (Drug)
HCTZ 25 mg
Active Comparator
干预措施: Hydrochlorothiazide (Drug)
结局指标
主要结局
Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 4
时间窗: Baseline and Week 4
次要结局
- Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 4(Baseline and Week 4)
- Change in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (in Patients With msDBP ≥90 mmHg at Baseline) From Baseline to Week 8(Baseline and Week 8)
- Percentage of Responders at Week 4 and Week 8(At 4 weeks and 8 weeks)
- Percentage of Subjects Achieving Blood Pressure Control at Weeks 4 and 8(At Weeks 4 and 8)
研究者
研究点 (1)
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