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CompletedNCT00367978Updated Nov 8, 2011

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

A Phase 4 interventional study of Amlodipine/benazepril in Hypertension, sponsored by Novartis. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-11-08.

Sponsored by Novartis · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
275
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Hypertension

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Keywords

  • Hypertension, diabetes, African-American, amlodipine/benazepril
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 275 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
275 participants (actual)

Interventions

  • DrugAmlodipine/benazepril
06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. change from baseline in sitting diastolic BP at Week 24

  2. change from baseline in sitting systolic BP at Week 24

  3. change from baseline in urinary protein excretion at Week 24

  4. change from baseline in HbA1c at Week 24

  5. change from baseline in estimated glomerular filtration rate (EGFR) at Week 24

07

Study locations

1 site
  • Novartis Pharmaceuticals Corporation
    East Hanover, New Jersey 07936, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00367978
Lead sponsor
Novartis
Responsible party
Sponsor
First posted
Aug 24, 2006
Start date
Dec 2001
Primary completion
Sep 2003
Completion
Sep 2003
Last update
Nov 8, 2011

Study contacts

Novartis Pharmaceuticals Corporation
study director · Novartis Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2006. You cannot join it, but the record below documents what was studied.

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