Status:
COMPLETED
Blood Pressure Lowering of Aliskiren HCTZ Compared to HCTZ in Stage 2 Systolic Hypertension in Older Population
Lead Sponsor:
Novartis
Conditions:
Hypertension
Eligibility:
All Genders
55+ years
Phase:
PHASE4
Brief Summary
The purpose of the study is to evaluate the efficacy and safety of initial use of a fixed dose combination of aliskiren Hydrochlorothiazide (HCTZ) compared to Hydrochlorothiazide in older population w...
Eligibility Criteria
Inclusion
- Male or female outpatients, ≥ 55 years old
- Patients with essential hypertension
- Prior to randomization: Patients must have an office cuff mean sitting Systolic Blood Pressure ≥ 160 mm Hg and \< 200 mm Hg
- Patients who are eligible and able to participate in the study, and who are willing to give informed consent before any assessment is performed
Exclusion
- Office blood pressure measured by cuff (msSBP ≥ 200 mm Hg and/or msDBP ≥ 110 mm Hg) at Visits 1-5
- History or evidence of a secondary hypertension of any etiology (e.g., uncorrected renal artery stenosis, pheochromocytoma).
- History of hypertensive encephalopathy or heart failure (New York Heart Association \[NYHA\] Class II-IV)
- Cerebrovascular accident, transient ischemic cerebral attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI) within 1 year prior to Visit 1
- Serum sodium less than the lower limit of normal, serum potassium \< 3.5 mEq/L (corresponding to 3.5 mmol/L) or ≥ 5.3 mEq/L (corresponding to 5.3 mmol/L), or dehydration at Visit 1.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\> 5 mIU/mL)
- Use of other investigational drugs within 30 days of enrollment.
- Other exclusions may apply.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
451 Patients enrolled
Trial Details
Trial ID
NCT00760266
Start Date
September 1 2008
End Date
April 1 2009
Last Update
April 4 2011
Active Locations (1)
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1
Sites in USA
East Hanover, New Jersey, United States, 07936