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CompletedNCT00136851Updated Nov 8, 2011

Study Comparing the Efficacy of Amlodipine Besylate/Benazepril Versus Amlodipine in the Treatment of Severe Hypertension

A Phase 4 interventional study of amlodipine besylate/benazepril hydrochloride in Hypertension, sponsored by Novartis Pharmaceuticals. 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 Pharmaceuticals · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
259
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

This trial is designed to study the efficacy of an amlodipine besylate/benazepril treatment regimen versus an amlodipine treatment regimen in the treatment of severe hypertension.

02

Conditions studied

  • Hypertension

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Keywords

  • Hypertension
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 259 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

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

  • Diagnosis of severe hypertension

Exclusion criteria

Exclusion Criteria:

  • Diastolic blood pressure (DBP) \< 60 mm Hg
  • Serum potassium \< 3.5 or > 5.5 mEq/L in the absence of all potassium supplements
  • Refractory hypertension defined as systolic blood pressure (SBP) ≥ 180 mmHg and/or DBP ≥ 110 mmHg and unresponsive to triple-drug regimens

Other protocol-defined exclusion criteria may apply.

05

Study design

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

Interventions

  • Drugamlodipine besylate/benazepril hydrochloride
06

What researchers measure

Primary outcomes

  1. Percentage of subjects achieving blood pressure goal which is defined as < 140/90 mm Hg, or < 130/80 mm Hg in subjects with diabetes after 4 weeks

Secondary outcomes

  1. Percentage of subjects achieving blood pressure goal, defined as < 140/90 mm Hg, or < 130/80 mm Hg in subjects with diabetes after 6 weeks

  2. Change from baseline in the mean sitting systolic blood pressure after 4 and 6 weeks

  3. Change from baseline in the mean sitting diastolic blood pressure after 4 and 6 weeks

  4. Percentage of subjects with swelling in legs or arms after 4 and 6 weeks

07

Study locations

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

References and documents

Publications

  • Izzo JL Jr, Purkayastha D, Hall D, Hilkert RJ. Comparative efficacy and safety of amlodipine/benazepril combination therapy and amlodipine monotherapy in severe hypertension. J Hum Hypertens. 2010 Jun;24(6):403-9. doi: 10.1038/jhh.2009.80. Epub 2009 Nov 5. PubMed 19890370 ↗
09

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 ↗
10

Registry details

Key details

Study ID
NCT00136851
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Aug 29, 2005
Start date
Dec 2004
Primary completion
Jul 2005
Completion
Jul 2005
Last update
Nov 8, 2011

Study contacts

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

Not currently enrolling

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

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