Status:
COMPLETED
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
Lead Sponsor:
Novartis
Conditions:
Hypertension
Eligibility:
All Genders
65+ years
Phase:
PHASE3
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
- 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
- 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.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
756 Patients enrolled
Trial Details
Trial ID
NCT00706134
Start Date
May 1 2008
End Date
April 1 2009
Last Update
June 28 2011
Active Locations (8)
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1
Investigative Site
Buenos Aires, Argentina
2
Investigative Site
Prague, Czechia
3
Investigative Site
Berlin, Germany
4
Investigative Site
Reykjavik, Iceland