Expired Study
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East Hanover, New Jersey 07936


Purpose:

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 with Stage 2 systolic hypertension.


Criteria:

Inclusion Criteria: 1. Male or female outpatients, ≥ 55 years old 2. Patients with essential hypertension 3. Prior to randomization: Patients must have an office cuff mean sitting Systolic Blood Pressure ≥ 160 mm Hg and < 200 mm Hg 4. 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 Criteria: 1. Office blood pressure measured by cuff (msSBP ≥ 200 mm Hg and/or msDBP ≥ 110 mm Hg) at Visits 1-5 2. History or evidence of a secondary hypertension of any etiology (e.g., uncorrected renal artery stenosis, pheochromocytoma). 3. History of hypertensive encephalopathy or heart failure (New York Heart Association [NYHA] Class II-IV) 4. 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 5. 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. 6. 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) 7. Use of other investigational drugs within 30 days of enrollment. Other exclusions may apply.


NCT ID:

NCT00760266


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

East Hanover, New Jersey 07936
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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