Clinical trial NCT00706134: 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
Official title: An Eight-week Double-blind, Multi-center, Randomized, Placebo-controlled, Parallel-group Study to 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Hypertension
≥ 65 years
aliskiren
placebo
light meal
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-06-27
Enrollment: 756
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Mean Sitting Systolic Blood Pressure (msSBP)From Baseline to End of Study (Week 8)
timeFrame: Baseline to end of study (Week 8)
Secondary outcomes:
measure: Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)
timeFrame: Baseline to end of study (Week 8)
measure: Percentage of Patients Achieving Systolic Blood Pressure Response
timeFrame: Baseline to end of study (Week 8)
measure: Change in Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure From Baseline to End of Study
timeFrame: Baseline to end of study (Week 8)
measure: Change in the Smoothness Index (SI) of the Ambulatory Systolic Blood Pressure From Baseline to End of Study (Week 8)
timeFrame: Baseline to end of study (Week 8)
measure: Change in Morning Surge of Ambulatory Systolic Blood Pressure From Baseline to End of Study (Week 8)
timeFrame: Baseline to end of study (week 8)
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Investigative Site
city: Prague
country: Czech Republic
facility: Investigative Site
city: Berlin
country: Germany
facility: Investigative Site
city: Reykjavik
country: Iceland
facility: Investigative Site
city: Rome
country: Italy
facility: Investigative Site
city: Amsterdam
country: Netherlands
facility: Investigative Site
city: Warsaw
country: Poland
facility: Investigative Site
city: Bratislava
country: Slovakia
facility: Investigative Site
Study officials:
References: