An 8-week Randomized, Double-blind, Parallel-group, Multi-center, Forced-titration Study to Evaluate the Efficacy and Safety of Aliskiren Plus HCTZ Compared to Aliskiren Monotherapy in Metabolic Syndrome Patients With Stage 2 Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 532
- 试验地点
- 1
- 主要终点
- Change From Baseline to Week 8 in Mean Sitting Systolic Blood Pressure (msSBP)
研究概览
简要总结
The purpose of the study is to evaluate the blood pressure lowering effect and safety of aliskiren in combination with Hydrochlorothiazide (HCTZ) compared to aliskiren monotherapy when given to metabolic syndrome patients with stage 2 systolic hypertension (mean sitting systolic blood pressure [msSBP] ≥ 160 mm Hg and < 200 mm Hg).
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 (Participant, Investigator)
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
- •Patients who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed.
- •Male or female outpatients ≥ 18 years old.
- •Patients with stage 2 systolic hypertension. Patients must have a msSBP ≥160 mmHg and <200 mmHg at Study Visit 5 (randomization).
- •Patients who have stage 2 systolic hypertension that meet at least 2 additional components of the metabolic syndrome as defined by the National *Cholesterol Education program (NCEP) criteria:
- •Abdominal obesity (waist circumference > than 102 cm for men and > 88 cm for women)
- •Current triglycerides ≥ 150 mg/dL or medical treatment for this condition.
- •Current HDL- Cholesterol <40 mg/dL in men and <50 mg/dL in women or medical treatment for this condition.
- •Fasting glucose >100 mg/dL and <126 mg/dL
排除标准
- •Office blood pressure measured by cuff (msDBP ≥ 110 mmHg and or msSBP ≥ 200 mmHg) at any visit.
- •Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
- •Use of aliskiren and/or a fixed dose combination of aliskiren HCTZ or participation in a clinical trial that had aliskiren and/or aliskiren HCTZ as treatment within 30 days of Visit
- •History of hypersensitivity to any of the medications or to drugs belonging to a similar therapeutic class (diuretics or renin inhibitors) as the study drugs.
- •History or evidence of secondary form of hypertension.
- •Refractory hypertension, defined as unresponsive to triple drug therapy at the maximum dose of each drug, one of which must be a diuretic, and not at blood pressure goal (140/90mmHg). Therapy with a fixed dose combination of two active substances represent two drugs.
- •Patients on 4 or more antihypertensive medications.
研究组 & 干预措施
Aliskiren plus Hydrochlorothiazide
Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.
干预措施: Aliskiren (Drug)
Aliskiren plus Hydrochlorothiazide
Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.
干预措施: Hydrochlorothiazide (Drug)
Aliskiren
Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
干预措施: Aliskiren (Drug)
结局指标
主要结局
Change From Baseline to Week 8 in Mean Sitting Systolic Blood Pressure (msSBP)
时间窗: Baseline and Week 8
次要结局
- Change From Baseline to Week 8 in Mean Sitting Diastolic Blood Pressure (msDBP)(8 weeks)
- Percentage of Participants With Blood Pressure Response at Week 8(8 weeks)
- Percentage of Patients Achieving Blood Pressure Control at Week 8(8 weeks)
- Change From Baseline to Week 8 in Pulse Pressure(Baseline and Week 8)