Efficacy of Aliskiren Compared to Ramipril in the Treatment of Moderate Systolic Hypertensive Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 506
- 试验地点
- 3
- 主要终点
- Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
研究概览
简要总结
This prospective multicenter, double blind study will evaluate the efficacy and safety of aliskiren versus ramipril in patients with moderate systolic essential 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, Investigator, Outcomes Assessor)
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
- •Outpatients > 18 years
- •Male or female patients. Female patients must have been either post-menopausal for one year, surgically sterile, or using effective contraceptive methods
- •Patients with essential hypertension, previously treated with an antihypertensive single-drug therapy, either uncontrolled or intolerant.
- •BP thresholds at visit 1:
- •For patients previously treated and uncontrolled: 140≤ office SBP<180 mmHg
- •For patients previously treated, controlled but intolerant: office SBP≥130 mmHg
- •BP thresholds at visit 2 (for all patients):
- •160≤office SBP<180 mmHg AND
- •155≤home SBP<175 mmHg (3-day period of home blood pressure monitoring just before randomization)
排除标准
- •Women of child-bearing potential not using any effective methods of contraception
- •Severe hypertension (office BP ≥ 180/110 mmHg)
- •Impossibility to stop abruptly previous antihypertensive treatments at visit 1
- •Patients previously untreated or patients treated with two or three antihypertensive medications
- •History or evidence of a secondary form of hypertension
- •History of hypersensitivity to ACEi or renin inhibitors
- •History of heart failure, stroke or coronary heart disease
- •Serum potassium ≥ 5.2 mmol/l
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Ramipril
In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.
In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.
In period III (double-blind withdrawal): At visit 4, part of patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4).
干预措施: Ramipril (Drug)
Ramipril
In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.
In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.
In period III (double-blind withdrawal): At visit 4, part of patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4).
干预措施: Matching placebo to Aliskiren (Drug)
Aliskiren
In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.
In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.
In period III (double-blind withdrawal ): At visit 4, part of the patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4).
干预措施: Aliskiren (Drug)
Aliskiren
In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.
In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.
In period III (double-blind withdrawal ): At visit 4, part of the patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4).
干预措施: Matching placebo to Ramipril (Drug)
Placebo to Ramipril
In period III (double-blind withdrawal ): At visit 4, part of patients from Ramipril arm received placebo to Ramipril for 1 day. The study ended at visit 5 (48 hours later than visit 4).
干预措施: Matching placebo to Ramipril (Drug)
Placebo to Aliskiren
In period III (double-blind withdrawal ): At visit 4, part of the patients from Aliskiren arm received placebo to Aliskiren for 1 day. The study ended at visit 5 (48 hours later than visit 4).
干预措施: Matching placebo to Aliskiren (Drug)
结局指标
主要结局
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
时间窗: Baseline to 8 weeks
The arm in which the highest sitting systolic blood pressure (SBP) was found at study entry was used for all subsequent readings. At each study visit, after leaving the patient to rest 5 minutes in a sitting position, the blood pressure (BP) was measured three times with an oscillometric device. The measurements were performed at 1-2 minute intervals. The mean BP was calculated from the 3 readings. The analysis of covariance included treatment factor and baseline mean sitting SBP as covariable.
次要结局
- Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)(Baseline to 8 weeks)
- Percentage of Patients With Controlled Blood Pressure(At 4 and 8 weeks)
- Number of the Participants With More Than 55 mmHg Difference Between the Mean SBP Measured at the Morning Surge and the Mean Minimal SBP Measured During the Night(After 8 weeks)
- Change in msSBP and msDBP From Visit 2 (Baseline) to Visit 3 (at 4 Weeks)(Baseline to 4 weeks)
- Difference Between the Maximal and the Minimal Mean-hour SPB Measured Between 1 and 8 am at Week 8(At week 8)
- Change in Mean Sitting DBP and SBP in Specified Sub-groups From Visit 2 (Baseline) to Visit 4 (at 8 Weeks)(Baseline to 8 weeks)
- Change in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) From Last Active Dose Taken to After a One-day Missed-dose(From 8 weeks to 48 hours after week 8)
- Number Patients Reported With Adverse Events (AEs), Serious Adverse Events (SAE) and Death (Period II and Period III)(8 weeks + 1 day)