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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

NCT ID: NCT00853957

Last Updated: 2012-04-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

443 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension

Keywords

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Hypertension African Americans Aliskiren Amlodipine Systolic blood pressure Diastolic blood pressure Stage II Combination

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Aliskiren/Amlodipine

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

Group Type EXPERIMENTAL

Aliskiren/Amlodipine

Intervention Type DRUG

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

Amlodipine

Amlodipine 5mg titrated to 10 mg

Group Type ACTIVE_COMPARATOR

Amlodipine

Intervention Type DRUG

Amlodipine 5 mg titrated to 10mg

Interventions

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Aliskiren/Amlodipine

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

Intervention Type DRUG

Amlodipine

Amlodipine 5 mg titrated to 10mg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis

Role: STUDY_DIRECTOR

Novartis

Locations

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Investigative Site

Chicago, Illinois, United States

Site Status

Investigative Site

Baltimore, Maryland, United States

Site Status

Investigative Site

Oxon Hill, Maryland, United States

Site Status

Investigative Site

Detroit, Michigan, United States

Site Status

Investigative Site

Trenton, New Jersey, United States

Site Status

Investigative Site

Brooklyn, New York, United States

Site Status

Investigative Site

Springfield Gardens, New York, United States

Site Status

Investigative Site

Philadelphia, Pennsylvania, United States

Site Status

Investigative Site

Milwaukeee, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 21925996 (View on PubMed)

Other Identifiers

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CSPA100AUS01

Identifier Type: -

Identifier Source: org_study_id