NCT00809926已完成4 期
An 8-week Randomized, Double-Blind, Parallel Group, Multi-Center, Active Controlled Study to Evaluate the Efficacy and Safety of Valsartan Administered in Combination With Aliskiren (160/150 mg, 320/300 mg) Versus Valsartan Alone (160 mg, 320 mg) in Patients With Stage 2 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 From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8
研究概览
简要总结
To evaluate the efficacy and safety of the valsartan/aliskiren combination compared to valsartan alone in patients with Stage 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
- Double (Participant, Care Provider)
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.
- •Men or women 18 years and older.
- •Patients with Stage 2 systolic hypertension; defined as having a MSSBP ≥160 mmHg and <180 mmHg at Visit 5 (randomization).
排除标准
- •Use of aliskiren or participation in a clinical trial that had aliskiren as treatment within 30 days of 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).
- •Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy OR are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation), hormonal contraception (implantable, patch, oral), and double-barrier methods. Reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation.
- •Severe hypertension (an office cuff MSDBP ≥110 mmHg and/or MSSBP ≥180 mmHg).
- •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 (140/90 mmHg).
- •Patients treated with more than 3 antihypertensive medications (each component of a combination drug counts individually).
- •History or evidence of a secondary form of hypertension.
研究组 & 干预措施
Valsartan/aliskiren
Experimental
干预措施: Valsartan/aliskiren (Drug)
Valsartan
Active Comparator
干预措施: Valsartan (Drug)
结局指标
主要结局
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8
时间窗: Baseline to Week 8
To compare the change from baseline in MSSBP after 8 weeks of treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension.
次要结局
- Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8(Baseline to Week 8)
- Percentage of Patients Achieving Blood Pressure Control (Defined as Patients Achieving a MSSBP <140 mmHg and MSDBP <90 mmHg) at Week 8(At Week 8)
- Percentage of Responders (Defined as Patients With MSSBP <140 mmHg or a Decrease From Baseline ≥20 mmHg) at Week 8(At Week 8)
- Mean Change From Baseline in Plasma Renin Activity (PRA) at Week 8(Baseline to Week 8)
- Mean Change From Baseline in Plasma Renin Concentration (PRC) at Week 8(Baseline to Week 8)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Clinical Study to Evaluate Efficacy and Safety of Aliskiren (150mg & 300mg) Administered Alone and in Combo With Valsartan (160mg and 320mg) in Patients With High Blood PressureHypertensionNCT00219180Novartis1,797
已完成
3 期
Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients Not Adequately Responding to Aliskiren AloneHypertensionNCT00777946Novartis818
已完成
3 期
Aliskiren in Combination With Losartan Compared to Losartan on the Regression of Left Ventricular Hypertrophy in Overweight Patients With Essential HypertensionLeft Ventricular HypertrophyOverweightHypertensionNCT00219141Novartis Pharmaceuticals460
已完成
3 期
Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients With Hypertension Not Adequately Responding to Amlodipine AloneHypertensionNCT00778921Novartis847
已完成
2 期
Efficacy and Safety of Aliskiren in Patients With Mild to Moderate Hypertension During ExerciseHypertensionNCT00819767Novartis68