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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00853957
First received: February 26, 2009
Last updated: April 26, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: Aliskiren/Amlodipine
Drug: Amlodipine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    To compare the change from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks of treatment with a combination of aliskiren and amlodipine treatment regimen (150/5 mg, 300/10 mg) versus an amlodipine treatment regimen (5 mg, 10 mg) in African American patients with Stage 2 hypertension.


Secondary Outcome Measures:
  • Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    To compare the change from baseline in mean sitting diastolic blood pressure (msDBP) after 8 weeks of treatment with a combination of aliskiren and amlodipine treatment regimen (150/5 mg, 300/10 mg) versus an amlodipine treatment regimen (5 mg, 10 mg).

  • Percentage of Patients Achieving Blood Pressure (BP) Control (<140/90 mmHg) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Cumulative percentage of patients achieving BP control (<140/90 mmHg)for both treatment arms was calculated. Cumulative refers to achieving blood pressure control before or at the corresponding visit. If achieving blood pressure control occurred more than once, only the first occurrence was counted.

  • Percentage of Responders (Patients With MSSBP < 140 mmHg or Decrease From Baseline of Greater Than or Equal to 20 mmHg) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Cumulative percentage of responders (Responders are defined as patients with MSSBP <140 mmHg or a decrease from baseline ≥20 mmHg) during 8 weeks of treatment was calculated. Cumulative refers to achieving blood pressure control before or at the corresponding visit. If achieving blood pressure control occurred more than once, only the first occurrence was counted.

  • Change From Baseline in MSSBP at Week 1 and 4 [ Time Frame: Baseline, 1 and 4 weeks ] [ Designated as safety issue: Yes ]
    Compare the change from baseline in MSSBP at week 1 and 4

  • Percentage of Patients With Peripheral Edema by Visit [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    Cumulative percentage of patients with peripheral edema was calculated. 'Cumulative' refers to patients with peripheral edema before or at the corresponding visit. If peripheral edema occurred more than once, only the first occurrence was counted. Peripheral edema is the swelling of tissues due to the accumulation of fluids. Peripheral edema was assessed by investigators during physical examination.


Enrollment: 443
Study Start Date: February 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aliskiren/Amlodipine
Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
Drug: Aliskiren/Amlodipine
Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
Active Comparator: Amlodipine
Amlodipine 5mg titrated to 10 mg
Drug: Amlodipine
Amlodipine 5 mg titrated to 10mg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00853957

Locations
United States, Illinois
Investigative Site
Chicago, Illinois, United States
United States, Maryland
Investigative Site
Baltimore, Maryland, United States
Investigative Site
Oxon Hill, Maryland, United States
United States, Michigan
Investigative Site
Detroit, Michigan, United States
United States, New Jersey
Investigative Site
Trenton, New Jersey, United States
United States, New York
Investigative Site
Brooklyn, New York, United States
Investigative Site
Springfield Gardens, New York, United States
United States, Pennsylvania
Investigative Site
Philadelphia, Pennsylvania, United States
United States, Wisconsin
Investigative Site
Milwaukeee, Wisconsin, United States
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Novartis
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00853957     History of Changes
Other Study ID Numbers: CSPA100AUS01
Study First Received: February 26, 2009
Results First Received: December 6, 2010
Last Updated: April 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Hypertension
African Americans
Aliskiren
Amlodipine
Systolic blood pressure
Diastolic blood pressure
Stage II
Combination

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 20, 2014