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

November 7, 2011 updated by: Novartis

A Randomized, Multicenter, Study to Determine the Efficacy and Safety of Amlodipine/Benazepril Hydrochloride Versus Enalapril in the Treatment of Hypertension in an African-American Population With Type 2 Diabetes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

275

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • East Hanover, New Jersey, United States, 07936
        • Novartis Pharmaceuticals Corporation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time from baseline to the achievement of first treatment success (defined as achieving a blood pressure (BP) <130/80 mm Hg). The proportion and cumulative proportion of patients who achieved first treatment success were also determined.

Secondary Outcome Measures

Outcome Measure
change from baseline in sitting diastolic BP at Week 24
change from baseline in sitting systolic BP at Week 24
change from baseline in urinary protein excretion at Week 24
change from baseline in HbA1c at Week 24
change from baseline in estimated glomerular filtration rate (EGFR) at Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2001

Primary Completion (ACTUAL)

September 1, 2003

Study Completion (ACTUAL)

September 1, 2003

Study Registration Dates

First Submitted

August 23, 2006

First Submitted That Met QC Criteria

August 23, 2006

First Posted (ESTIMATE)

August 24, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

November 8, 2011

Last Update Submitted That Met QC Criteria

November 7, 2011

Last Verified

August 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCIB002FUS06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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