An 8-week Double-blind, Multicenter, Randomized, Multifactorial, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Aliskiren Administered Alone and in Combination With Amlodipine in Patients With Essential Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,694
- 试验地点
- 2
- 主要终点
- Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Aliskiren 150 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
研究概览
简要总结
Evaluate the efficacy (blood pressure lowering effect) and safety of aliskiren alone and in combination with amlodipine in patients with essential hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, 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
- •msDBP ≥ 90 mmHg and < 110 mmHg at the visit prior to Visit 3 (Visit 2 or optional Visit 201)
- •msDBP ≥ 95 mmHg and < 110 mmHg at Visit 3 (Day 1 / randomization).
- •All patients must have an absolute difference of ≤ 10 mmHg in their msDBP during the last 2 visits of the single-blind run-in period (Visit 2 and 3 or Visits 201 and 3).
排除标准
- •Severe hypertension
- •Pregnant or nursing (lactating) women
- •Women of child-bearing potential
- •Previous or current diagnosis of heart failure (NYHA Class II-IV).
- •Serum potassium ≥ 5.3 mEq/L (mmol/L) at Visit
- •Uncontrolled Type 1 or Type 2 diabetes mellitus
- •Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with Similar chemical structures
- •History of malignancy within 5 years
- •History of hypertensive encephalopathy or cerebrovascular accident, or history of transient ischemic attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention
研究组 & 干预措施
Placebo
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 5 of the 5 pills taken were placebos.
干预措施: Placebo (Drug)
Aliskiren 150 mg tablet
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
干预措施: Placebo (Drug)
Aliskiren 150 mg tablet
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
干预措施: Aliskiren 150 mg tablet (Drug)
Aliskiren 300 mg tablet
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
干预措施: Placebo (Drug)
Aliskiren 300 mg tablet
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
干预措施: Aliskiren 300 mg tablet (Drug)
Amlodipine 5 mg capsule
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
干预措施: Placebo (Drug)
Amlodipine 5 mg capsule
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
干预措施: Amlodipine 5 mg capsule (Drug)
Amlodipine 10 mg capsule
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg
干预措施: Placebo (Drug)
Amlodipine 10 mg capsule
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg
干预措施: Amlodipine 10 mg capsule (Drug)
Aliskiren/amlodipine 150/5 mg tablet
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
干预措施: Placebo (Drug)
Aliskiren/amlodipine 150/5 mg tablet
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
干预措施: Aliskiren/amlodipine 150/5 mg tablet (Drug)
Aliskiren/amlodipine 150/10 mg tablet
150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
干预措施: Placebo (Drug)
Aliskiren/amlodipine 150/10 mg tablet
150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
干预措施: Aliskiren/amlodipine 150/10 mg tablet (Drug)
Aliskiren/amlodipine 300/5 mg tablet
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
干预措施: Placebo (Drug)
Aliskiren/amlodipine 300/5 mg tablet
Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
干预措施: Aliskiren/amlodipine 300/5 mg tablet (Drug)
Aliskiren/amlodipine 300/10 mg tablet
300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
干预措施: Placebo (Drug)
Aliskiren/amlodipine 300/10 mg tablet
300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
干预措施: Aliskiren/amlodipine 300/10 mg tablet (Drug)
结局指标
主要结局
Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Aliskiren 150 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
时间窗: Baseline to end of study (Week 8)
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
时间窗: Baseline to end of study (Week 8)
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
时间窗: Baseline to end of study (Week 8)
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Aliskiren 150 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
时间窗: Baseline to end of study (Week 8)
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
时间窗: Baseline to end of study (Week 8)
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
时间窗: Baseline to end of study (Week 8)
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Aliskiren 300 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
时间窗: Baseline to end of study (Week 8)
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
时间窗: Baseline to end of study (Week 8)
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
时间窗: Baseline to end of study (Week 8)
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Aliskiren 300 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
时间窗: Baseline to end of study (Week 8)
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
时间窗: Baseline to end of study (Week 8)
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
时间窗: Baseline to end of study (Week 8)
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
次要结局
- Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Aliskiren 150 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)(Baseline to end of study (Week 8))
- Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)(Baseline to end of study (Week 8))
- Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)(Baseline to end of study (Week 8))
- Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Aliskiren 150 mg on Change in Mean Sitting Systolic Blood Pressure (mssBP)(Baseline to end of study (Week 8))
- Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)(Baseline to end of study (Week 8))
- Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)(Baseline to end of study (Week 8))
- Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Aliskiren 300 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)(Baseline to end of study (Week 8))
- Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)(Baseline to end of study (Week 8))
- Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)(Baseline to end of study (Week 8))
- Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Aliskiren 300 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)(Baseline to end of study (Week 8))
- Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)(Baseline to end of study (Week 8))
- Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)(Baseline to end of study (Week 8))
- Percentage of Patients With Blood Pressure Control (msSBP < 140 mm Hg and msDBP < 90 mm Hg) at End of Study(End of study (Week 8))
- Percentage of Patients Achieving a Successful Diastolic Blood Pressure Response(End of study (Week 8))
- Percentage of Patients Achieving a Successful Systolic Blood Pressure Response(End of study (Week 8))