Blood Pressure Lowering of Aliskiren HCTZ Compared to HCTZ in Stage 2 Systolic Hypertension in Older Population
Completed · Phase 4
Conditions studied: Hypertension
In brief
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.
Key facts
- Study ID
- NCT00760266
- Run by
- Novartis
- People needed
- 451
- Starts
- 2008-09-01
- Expected to finish
- 2009-04-01
- Last updated by the study team
- 2011-04-04
Who can join
Age: 55 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Sites in USA — East Hanover, New Jersey, United States
Full record on ClinicalTrials.gov
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