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Effects of Amlodipine/Benazepril in the Hypertensive African-American Population With Type 2 Diabetes Mellitus

NCT ID: NCT00367978

Last Updated: 2011-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

275 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-12-31

Study Completion Date

2003-09-30

Brief Summary

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This study evaluated the efficacy and safety of amlodipine/benazepril compared with that of enalapril in the treatment of hypertension in African-American patients with type 2 diabetes.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Amlodipine/benazepril

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* African-American
* males and females
* current diagnosis of type 2 diabetes documented by medical history;
* mean sitting diastolic blood pressure of ≥ 90 and ≤ 110 mm Hg;
* HbA1C ≤ 9.5%

Exclusion Criteria

* having unilateral or bilateral renal artery stenosis;
* having clinically significant cardiac dysrhythmias;
* having a significant history of coronary artery disease within the past 6 months;
* having a history or diagnosis of congestive heart failure (CHF);
* having any clinically relevant cardiac valvular disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 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 Pharmaceuticals Corporation

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Pharmaceuticals Corporation

East Hanover, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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CCIB002FUS06

Identifier Type: -

Identifier Source: org_study_id