Moderate to Severe Hypertension Clinical Trial
Official title:
An 8-week, Double-blind, Randomized, Parallel Group, Multi-center Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren 300 mg and Amlodipine 10 mg Compared to Amlodipine 10 mg in Patients
This study will compare the blood pressure (BP) lowering effect of the combination of aliskiren/amlodipine 300/10 mg versus amlodipine 10 mg monotherapy in patients with moderate to severe hypertension by testing the hypothesis that the combination of aliskiren/amlodipine produces a superior reduction from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks of treatment.
| Status | Completed |
| Enrollment | 485 |
| Est. completion date | September 2009 |
| Est. primary completion date | September 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Outpatients = 18 years of age - Patients with a diagnosis of moderate to severe hypertension, defined as msSBP = 160 mmHg and < 200 mmHg at Visit 2 Exclusion Criteria: - Mild to moderate hypertension - Pregnant or nursing (lactating) women - Women of child-bearing potential - Previous or current diagnosis of heart failure New York Heart Association(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 hypertensive encephalopathy or cerebrovascular accident, or history of transient ischemic attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention - Patients on a combination of 3 or more antihypertensive medications Other protocol-defined inclusion/exclusion criteria may apply |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | Investigative Site | Berlin | |
| Philippines | Investigative Site | Manilla | |
| Romania | Investigative Site | Bucharest | |
| Russian Federation | Investigative Site | Moscow | |
| Singapore | Investigative Site | Singapore | |
| Spain | Investigative Site | Madrid |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis |
Germany, Philippines, Romania, Russian Federation, Singapore, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mean Sitting Systolic Blood Pressure (msSBP) | Change in mean sitting systolic blood pressure (msSBP) from baseline to end of study (Week 8) | Baseline to end of study (Week 8) | No |
| Secondary | Mean Sitting Diastolic Blood Pressure (msDBP) | Change in mean sitting diastolic blood pressure (msDBP) from baseline to end of study (Week 8) | Baseline to end of study (Week 8) | No |
| Secondary | Systolic Blood Pressure Response | Percentage of patients achieving a mean sitting systolic blood pressure response (msSBP < 140 mmHg or a reduction => 20 mmHg from the baseline) from baseline to end of study (Week 8) | Baseline to end of study (Week 8) | No |
| Secondary | Diastolic Blood Pressure Response | Percentage of patients achieving a mean sitting diastolic blood pressure response (msDBP < 90 mmHg or a reduction = 10 mmHg from the baseline) from baseline to end of study (Week 8) | Baseline to end of study (Week 8) | No |
| Secondary | Blood Pressure Control | Percentage of patients achieving blood pressure control (msSBP < 140 mm Hg and msDBP < 90 mm Hg) at end of study | End of study (Week 8) | No |