August 20, 2008 |
April 3, 2009 |
September 2008 |
Vital signs at every visit [ Time Frame: 10-12.5 weeks ] [ Designated as safety issue: No ] |
Same as current |
Complete list of historical versions of study NCT00739973 on ClinicalTrials.gov Archive Site |
- Vital signs at every visit [ Time Frame: 10-12.5 weeks ] [ Designated as safety issue: No ]
- Adverse events at every visit [ Time Frame: 10-12.5 weeks ] [ Designated as safety issue: Yes ]
- 24-hour blood pressure profile of in a subset of patients at Day 1 and Day 56 (end of study) [ Time Frame: Day 1 and Day 56 ] [ Designated as safety issue: No ]
- Biomarker assessments (PRA, PRC) at Day 1 and Day 56 in subset of patients. [ Time Frame: Day 1 and Day 56 ] [ Designated as safety issue: No ]
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Same as current |
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Study to Evaluate the Efficacy and Safety of Aliskiren Alone and in Combination With Amlodipine in Essential Hypertension |
An 8-Week Double-Blind, Multicenter, Randomized, Multifactorial, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Aliskiren Administered Alone and in Combination With Amlodipine in Patients With Essential Hypertension |
Evaluate the efficacy (blood pressure lowering effect) and safety of aliskiren alone and in combination with amlodipine in patients with essential hypertension. |
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Phase III |
Interventional |
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Factorial Assignment, Safety/Efficacy Study |
Hypertension |
- Drug: Aliskiren
- Drug: Amlodipine
- Drug: Aliskiren/amlodipine
- Drug: Placebo
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- Experimental: Aliskiren 150 mg
- Experimental: Aliskiren 300 mg
- Experimental: Amlodipine 5mg
- Experimental: Amlodipine 10 mg
- Experimental: Aliskiren/amlodipine 150/5 mg
- Experimental: Aliskiren/amlodipine 150/10 mg
- Experimental: Aliskiren/amlodipine 300/5 mg
- Experimental: Aliskiren/amlodipine 300/10 mg
- Experimental: Placebo
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Recruiting |
1611 |
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June 2009 (final data collection date for primary outcome measure) |
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
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Both |
18 Years and older |
No |
Contact: Novartis |
862-778-8300 |
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United States, Argentina, Australia, Canada, Colombia, Denmark, Dominican Republic, Finland, Greece, Italy, Mexico, Panama, Peru, Romania, Russian Federation, South Africa, Spain, Sweden, Taiwan |
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NCT00739973 |
External Affairs, Novartis |
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Novartis |
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Study Chair: |
Novartis |
Novartis |
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Novartis |
April 2009 |