Efficacy and Safety of Aliskiren Administered in Combination With Amlodipine Versus Amlodipine Alone in African American Patients With Stage 2 Hypertension

Completed · Phase 4

Conditions studied: Hypertension

In brief

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 with Stage II hypertension.

Key facts

Study ID

NCT00853957

Run by

Novartis

People needed

443

Starts

2009-02-01

Expected to finish

2009-08-01

Last updated by the study team

2012-04-30

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Investigative Site — Chicago, Illinois, United States
• Investigative Site — Baltimore, Maryland, United States
• Investigative Site — Oxon Hill, Maryland, United States
• Investigative Site — Detroit, Michigan, United States
• Investigative Site — Trenton, New Jersey, United States
• Investigative Site — Brooklyn, New York, United States
• Investigative Site — Springfield Gardens, New York, United States
• Investigative Site — Philadelphia, Pennsylvania, United States
• Investigative Site — Milwaukeee, Wisconsin, United States

Full record on ClinicalTrials.gov

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