Efficacy and Safety of Aliskiren 75 mg, 150 mg, and 300 mg in Elderly Patients With Essential Hypertension When Given With a Light Meal in a 8 Week Placebo-controlled Study
- Conditions
- Hypertension
- Interventions
- Registration Number
- NCT00706134
- Lead Sponsor
- Novartis
- Brief Summary
This study will evaluate the efficacy and safety of aliskiren 75 mg, 150 mg, and 300 mg in elderly patients with essential hypertension when given with a light meal.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 756
- Male and female outpatients 65 years of age and older.
- Patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent).
- At the randomization visit patients must have an office msSBP greater than or equal to 150 mmHg and < 180 mmHg (msDBP <110 mmHg) with a less than or equal to 15 mmHg difference during the last two visits of the single blind run-in period.
- Severe hypertension [Office msDBP ≥110 mmHg and/or mean sitting systolic blood pressure (msSBP) ≥ 180 mmHg].
- History or evidence of a secondary form of hypertension.
- Known Keith-Wagener grade III or IV hypertensive retinopathy.
- History of hypertensive encephalopathy or cerebrovascular accident, including a history of transient ischemic cerebral attack (TIA).
- Current diagnosis of heart failure (NYHA Class II-IV).
- History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI).
- Current angina pectoris requiring pharmacological therapy other than nitrates.
Other protocol-defined inclusion/exclusion criteria applied to the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Aliskiren 75 mg Aliskiren 75 mg - Aliskiren 150 mg Aliskiren 150 mg - Aliskiren 300 mg Aliskiren 300 mg -
- Primary Outcome Measures
Name Time Method Change in Mean Sitting Systolic Blood Pressure (msSBP)From Baseline to End of Study (Week 8) Baseline to end of study (Week 8)
- Secondary Outcome Measures
Name Time Method Percentage of Patients Achieving Systolic Blood Pressure Response Baseline to end of study (Week 8) Patients achieving a systolic blood pressure response had to have a msSBP \< 140 mmHg at the end of the study and/or a ≥ 20 mmHg reduction in msSBP from baseline to the end of the study.
Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8) Baseline to end of study (Week 8) Change in Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure From Baseline to End of Study Baseline to end of study (Week 8) Two 24-hour ambulatory blood pressure monitoring (ABPM) evaluations were performed, one at baseline and one at the end of the study. For each evaluation, the ABPM device was attached to the non-dominant arm of the patient.
Change in the Smoothness Index (SI) of the Ambulatory Systolic Blood Pressure From Baseline to End of Study (Week 8) Baseline to end of study (Week 8) Smoothness index (SI) is a measure of consistency of the BP reduction over 24 hours. The SI was obtained by first calculating the mean blood pressure value at each hour of the 24-hour ambulatory blood pressure monitoring period, both before and during treatment. Similarly, the change from baseline in blood pressure was calculated at each hour. The average hourly change from baseline (δh) and standard deviation (std δh) of the hourly changes were computed, and the SI was derived: SI = δh/std δh. A negative change score indicates improvement.
Change in Morning Surge of Ambulatory Systolic Blood Pressure From Baseline to End of Study (Week 8) Baseline to end of study (week 8) The morning surge was defined as the average of the hourly means in the last three hours (hours 22, 23, 24) of the 24 hour ambulatory blood pressure monitoring assessment period.
Trial Locations
- Locations (1)
Investigative Site
🇸🇰Bratislava, Slovakia