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

Novartis

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: Aliskiren/Amlodipine; Drug: Amlodipine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00853957

CSPA100AUS01

Details and patient eligibility

About

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.

Enrollment: 443 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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443 participants in 2 patient groups

Aliskiren/Amlodipine

Experimental group

Description:

Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg

Treatment:

Drug: Aliskiren/Amlodipine

Amlodipine

Active Comparator group

Description:

Amlodipine 5mg titrated to 10 mg

Treatment:

Drug: Amlodipine