Efficacy and Safety of Aliskiren Administered in Combination With Amlodipine Versus Amlodipine Alone in African American Patients With Stage 2 Hypertension
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Aliskiren/Amlodipine (Drug); Amlodipine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s): Novartis, Study Director, Affiliation: Novartis
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.
Clinical Details
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 design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
Secondary outcome: Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)Percentage of Patients Achieving Blood Pressure (BP) Control (<140/90 mmHg) Percentage of Responders (Patients With MSSBP < 140 mmHg or Decrease From Baseline of Greater Than or Equal to 20 mmHg) Change From Baseline in MSSBP at Week 1 and 4 Percentage of Patients With Peripheral Edema by Visit
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
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
Additional Information
Starting date: February 2009
Last updated: April 26, 2012
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