A Twelve-week, Randomized, Double-blind, Parallel Group Study to Evaluate the Prolonged Efficacy and Safety of Aliskiren 300 mg Compared to Telmisartan 80 mg in Mild to Moderate Hypertensive Patients With the 24-hour Ambulatory Blood Pressure Measurement After 1 Week of Treatment Withdrawal Study Acronym: ASSERTIVE - AliSkiren Study of Profound antihypERtensive Efficacy in hyperTensIVE Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 822
- 试验地点
- 2
- 主要终点
- Change in 24 Hour (24-Hr) Mean Ambulatory Systolic Blood Pressure (MASBP) From the End of the Active Treatment Period to Day 7 of the Withdrawal Period
研究概览
简要总结
This study was specifically designed to provide additional information on the mechanism of action of direct renin inhibition postulating the higher-level RAS cascade inhibition. The purpose of this study was to compare the prolonged efficacy and safety of aliskiren to that of telmisartan in mild to moderate hypertensive patients in the 24 hrs Ambulatory Blood Pressure Monitoring setting after a one week treatment withdrawal.
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
- •Mean sitting systolic blood pressure ≥ 140 mmHg and < 180 mmHg
- •24-hr mean ambulatory systolic blood pressure ≥ 135 mmHg
排除标准
- •Severe hypertension defined as mean sitting systolic blood pressure ≥ 180 mmHg and/or mean sitting diastolic blood pressure ≥ 110 mmHg
- •Patients with Type 1 diabetes mellitus
- •Secondary hypertension of any etiology
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Aliskiren 300 mg
Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
干预措施: Aliskiren (Drug)
Aliskiren 300 mg
Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
干预措施: Placebo to Aliskiren (Drug)
Telmisartan 80 mg
Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
干预措施: Telmisartan (Drug)
Telmisartan 80 mg
Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
干预措施: Placebo to Telmisartan (Drug)
结局指标
主要结局
Change in 24 Hour (24-Hr) Mean Ambulatory Systolic Blood Pressure (MASBP) From the End of the Active Treatment Period to Day 7 of the Withdrawal Period
时间窗: 12 weeks, 13 weeks
An Ambulatory Blood Pressure Monitor measured a participants's blood pressure over a 24 hour period using an automated validated monitoring device at week 12 (end of the active treatment) and at week 13 (end of the day 7 withdrawal period). The 24 Hour MASBP was calculated by taking the mean of all Ambulatory Systolic Blood Pressure readings for the 24 hour period. The difference of the 24 hour MASBP from the end of the active treatment to Day 7 of the treatment withdrawal period was calculated using a two way analysis of variance with treatment and region as factors.
次要结局
- Change in 24 Hour (24-hr) Mean Ambulatory Diastolic Blood Pressure (MADBP) From the End of the Active Treatment Period to Day 7 of the Withdrawal Period(12 weeks, 13 weeks)
- Change in 24-hr Mean Ambulatory Systolic Blood Pressure (MASBP) and Mean Ambulatory Diastolic Blood Pressure (MADBP) From Baseline to Day 7 of the Withdrawal Period(Baseline, 13 weeks)
- Change in the Mean Sitting Systolic Blood Pressure (msSBP) as Measured at All Study Visits During the Double-blind Treatment Period and During the Treatment Withdrawal Period(Baseline, 12 weeks, 13 weeks)
- Change in the Mean Diastolic Sitting Blood Pressure (msDBP) as Measured at All Study Visits During the Double-blind Treatment Period and During the Treatment Withdrawal Period(Baseline, 12 weeks, 13 weeks)