Expired Study
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East Hanover, New Jersey


Purpose:

Evaluate the efficacy (blood pressure lowering effect) and safety of aliskiren alone and in combination with amlodipine in patients with essential hypertension.


Criteria:

Inclusion Criteria: - msDBP ≥ 90 mmHg and < 110 mmHg at the visit prior to Visit 3 (Visit 2 or optional Visit 201) - msDBP ≥ 95 mmHg and < 110 mmHg at Visit 3 (Day 1 / randomization). - All patients must have an absolute difference of ≤ 10 mmHg in their msDBP during the last 2 visits of the single-blind run-in period (Visit 2 and 3 or Visits 201 and 3). Exclusion Criteria: - Severe hypertension - Pregnant or nursing (lactating) women - Women of child-bearing potential - Previous or current diagnosis of heart failure (NYHA Class II-IV). - Serum potassium ≥ 5.3 mEq/L (mmol/L) at Visit 1. - Uncontrolled Type 1 or Type 2 diabetes mellitus - Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with Similar chemical structures - History of malignancy within 5 years - History of hypertensive encephalopathy or cerebrovascular accident, or history of transient ischemic attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention


NCT ID:

NCT00739973


Primary Contact:

Study Chair
Novartis
Novartis


Backup Contact:

N/A


Location Contact:

East Hanover, New Jersey
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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