Status:
COMPLETED
Study to Evaluate the Efficacy and Safety of Aliskiren Alone and in Combination With Amlodipine in Essential Hypertension
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Evaluate the efficacy (blood pressure lowering effect) and safety of aliskiren alone and in combination with amlodipine in patients with essential hypertension.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
2694 Patients enrolled
Trial Details
Trial ID
NCT00739973
Start Date
September 1 2008
End Date
May 1 2009
Last Update
June 6 2011
Active Locations (18)
Enter a location and click search to find clinical trials sorted by distance.
1
Investigative Site
East Hanover, New Jersey, United States
2
Investigative Site
Buenos Aires, Argentina
3
Invesigative Site
Canberra, Australia
4
Investigative Site
Toronto, Canada