Clinical trial NCT00853957: Efficacy and Safety of Aliskiren Administered in Combination With Amlodipine Versus Amlodipine Alone in African American Patients With Stage 2 Hypertension
Official title: An 8-week Multicenter, Randomized, Double-blind, Active Control, Parallel Group Study to Evaluate the Efficacy and Safety of Aliskiren Administered in Combination With Amlodipine (150/5 mg, 300/10 mg) Versus Amlodipine Alone (5 mg, 10 mg) in African American Patients With Stage 2 Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Hypertension
African Americans
Aliskiren
Amlodipine
Systolic blood pressure
Diastolic blood pressure
Stage II
Combination
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-03-02
Enrollment: 443
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 with Stage II hypertension.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
timeFrame: Baseline, 8 weeks
Secondary outcomes:
measure: Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
timeFrame: Baseline, 8 weeks
measure: Percentage of Patients Achieving Blood Pressure (BP) Control (<140/90 mmHg)
timeFrame: 8 weeks
measure: Percentage of Responders (Patients With MSSBP < 140 mmHg or Decrease From Baseline of Greater Than or Equal to 20 mmHg)
timeFrame: 8 weeks
measure: Change From Baseline in MSSBP at Week 1 and 4
timeFrame: Baseline, 1 and 4 weeks
measure: Percentage of Patients With Peripheral Edema by Visit
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Investigative Site
state: Illinois
city: Baltimore
country: United States
facility: Investigative Site
state: Maryland
city: Oxon Hill
country: United States
facility: Investigative Site
state: Maryland
city: Detroit
country: United States
facility: Investigative Site
state: Michigan
city: Trenton
country: United States
facility: Investigative Site
state: New Jersey
city: Brooklyn
country: United States
facility: Investigative Site
state: New York
city: Springfield Gardens
country: United States
facility: Investigative Site
state: New York
city: Philadelphia
country: United States
facility: Investigative Site
state: Pennsylvania
city: Milwaukeee
country: United States
facility: Investigative Site
state: Wisconsin
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
citation: Weinberger MH, Izzo JL Jr, Purkayastha D, Weitzman R, Black HR. Comparative efficacy and safety of combination aliskiren/amlodipine and amlodipine monotherapy in African Americans with stage 2 hypertension and obesity or metabolic syndrome. J Am Soc Hypertens. 2011 Nov-Dec;5(6):489-97. doi: 10.1016/j.jash.2011.08.005. Epub 2011 Sep 17.