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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

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

Page last updated: August 23, 2015

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