An Eight-week, Randomized, Double-blind, Parallel-group, Pilot Study to Evaluate the Efficacy and Safety of Aliskiren 300 mg in Comparison With Valsartan 320 mg in Patients With Mild to Moderate Hypertension During Exercise After a Missed Dose
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Change in Resting vs. Peak Heart Rate Systolic Blood Pressure (SBP) From Baseline to Week 8 After a Missed Dose
研究概览
简要总结
This study compared the blunting effect of aliskiren and valsartan monotherapies on exercise-induced rises in systolic blood pressure in patients with mild to moderate 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Aliskiren
For the first week of the 8 week treatment period, patients received aliskiren 150 mg, placebo to aliskiren, and 2 capsules of placebo to valsartan. For the remaining 7 weeks of the study, patients received aliskiren 300 mg (two 150 mg tablets) and 2 capsules of placebo to valsartan. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
干预措施: Aliskiren (Drug)
Aliskiren
For the first week of the 8 week treatment period, patients received aliskiren 150 mg, placebo to aliskiren, and 2 capsules of placebo to valsartan. For the remaining 7 weeks of the study, patients received aliskiren 300 mg (two 150 mg tablets) and 2 capsules of placebo to valsartan. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
干预措施: Placebo to aliskiren (Drug)
Aliskiren
For the first week of the 8 week treatment period, patients received aliskiren 150 mg, placebo to aliskiren, and 2 capsules of placebo to valsartan. For the remaining 7 weeks of the study, patients received aliskiren 300 mg (two 150 mg tablets) and 2 capsules of placebo to valsartan. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
干预措施: Placebo to valsartan (Drug)
Valsartan
For the first week of the 8 week treatment period, patients received valsartan 160 mg, placebo to valsartan, and 2 tablets of placebo to aliskiren. For the remaining 7 weeks of the study, patients received valsartan 320 mg (two 160 mg capsules) and 2 tablets of placebo to aliskiren. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
干预措施: Valsartan (Drug)
Valsartan
For the first week of the 8 week treatment period, patients received valsartan 160 mg, placebo to valsartan, and 2 tablets of placebo to aliskiren. For the remaining 7 weeks of the study, patients received valsartan 320 mg (two 160 mg capsules) and 2 tablets of placebo to aliskiren. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
干预措施: Placebo to aliskiren (Drug)
Valsartan
For the first week of the 8 week treatment period, patients received valsartan 160 mg, placebo to valsartan, and 2 tablets of placebo to aliskiren. For the remaining 7 weeks of the study, patients received valsartan 320 mg (two 160 mg capsules) and 2 tablets of placebo to aliskiren. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
干预措施: Placebo to valsartan (Drug)
结局指标
主要结局
Change in Resting vs. Peak Heart Rate Systolic Blood Pressure (SBP) From Baseline to Week 8 After a Missed Dose
时间窗: Baseline and Week 8 + 2 days (48-hours after the last dose; 24 hours after a missed dose). Blood Pressure measurements were taken at rest and at peak heart rate at both timepoints.
The difference in resting vs. peak (85% of maximal predicted) heart rate (HR) SBP was calculated by measuring SBP before and during exercise on a standardized treadmill test, conducted according to the Bruce Protocol. Treadmill speed and incline were increased every 3 minutes until the patient was exhausted or peak HR was reached. The SBP at rest vs peak HR was recorded at Baseline and at Week 8 + 2 days (24-hrs after a missed dose); the change in rest vs. peak SBP between these timepoints is reported. The analysis included the rest to peak increase in SBP at baseline as a covariate.
次要结局
- Change in Resting vs. Peak Heart Rate Systolic Blood Pressure (SBP) From Baseline to Week 8(Baseline and Week 8 (end of active treatment). Blood Pressure measurements were taken at rest and at peak heart rate at both timepoints.)
- Change in Resting vs. Peak Heart Rate Systolic Blood Pressure (SBP) From Week 8 (End of Active Treatment) to 24-hours After a Missed Dose(Week 8 (Last dose; end of active treatment) and Week 8 + 2 days (48-hours after the last dose; 24 hours after a missed dose). Blood Pressure measurements were taken at rest and at peak heart rate at both timepoints.)