Status:
COMPLETED
Efficacy and Safety of Aliskiren Administered in Combination With Amlodipine Versus Amlodipine Alone in African American Patients With Stage 2 Hypertension
Lead Sponsor:
Novartis
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of the study is to evaluate the BP-lowering efficacy of the combination of aliskiren and amlodipine, as initial therapy, compared to amlodipine monotherapy in African American patients wit...
Eligibility Criteria
Inclusion
- Men or women of African American background; self identified
- Patients with stage 2 hypertension defined as MSSBP ≥ 160 mmHg and \< 200 mmHg at Visit 5 (randomization
Exclusion
- Office blood pressure measured by cuff (MSDBP ≥ 110 mmHg and/or MSSBP ≥ 200 mmHg)
- Patients on 4 or more antihypertensive medications.
- Patients with uncontrolled hypertension (MSSBP \>180 mmHg) taking more than 1 antihypertensive medication at Visit 1
- Refractory hypertension, defined as, unresponsive to triple drug therapy at the maximum dose of each drug, one of which must be a diuretic, and not at blood pressure goal (140/90 mmHg). Therapy with a fixed dose combination of two active substances represent two drugs.
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- Evidence of a secondary form of hypertension, including but not limited to any of the following:
- coarctation of the aorta
- hyperaldosteronism
- unilateral or bilateral renal artery stenosis
- Cushing's disease
- polycystic kidney disease
- pheochromocytoma
- Known Keith-Wagener grade III or IV hypertensive retinopathy.
- History of angioedema due to usage of an ARB or ACE inhibitor.
- History of hypertensive encephalopathy, cerebrovascular accident, transient ischemic attack, heart failure (NYHA Class II-IV), coronary bypass graft surgery (CABG), percutaneous coronary intervention (PCI), unstable angina pectoris, or myocardial infarction in the last 12 months
- Other protocol defined inclusion/exclusion criteria applied
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
443 Patients enrolled
Trial Details
Trial ID
NCT00853957
Start Date
February 1 2009
End Date
August 1 2009
Last Update
April 30 2012
Active Locations (9)
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1
Investigative Site
Chicago, Illinois, United States
2
Investigative Site
Baltimore, Maryland, United States
3
Investigative Site
Oxon Hill, Maryland, United States
4
Investigative Site
Detroit, Michigan, United States