Study to Evaluate the Efficacy and Safety of Aliskiren Alone and in Combination With Amlodipine in Essential Hypertension

Completed · Phase 3 · Has a placebo group

Conditions studied: Hypertension

In brief

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

Key facts

Study ID

NCT00739973

Run by

Novartis Pharmaceuticals

People needed

2694

Starts

2008-09-01

Expected to finish

2009-05-01

Last updated by the study team

2011-06-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Investigative Site — East Hanover, New Jersey, United States
• Investigative Site — Buenos Aires, Argentina
• Invesigative Site — Canberra, Australia
• Investigative Site — Toronto, Canada
• Investigative Site — Bogotá, Colombia
• Investigative Site — Copenhagen, Denmark
• Investigative Site — Oslo, Finland
• Investigative Site — Athens, Greece
• Investigative Site — Rome, Italy
• Investigative Site — Mexico City, Mexico
• Investigative Site — Panama City, Panama
• Investigative Site — Lima, Peru
• Investigative Site — Bucharest, Romania
• Investigative Site — Moscow, Russia
• Investigative Site — Pretoria, South Africa
• Investigative Site — Madrid, Spain
• Investigative Site — Stockholm, Sweden
• Investigative Site — Taipei, Taiwan

Full record on ClinicalTrials.gov

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