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

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Novartis

Status and phase

Completed
Phase 4

Conditions

Hypertension

Treatments

Drug: Amlodipine/benazepril

Study type

Interventional

Funder types

Industry

Identifiers

NCT00367978
CCIB002FUS06

Details and patient eligibility

About

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.

Enrollment

275 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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