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

A 6-Week Multi-center, Randomized, Double-Blind, Parallel Group Study Comparing the Efficacy of Amlodipine Besylate/Benazepril Versus Amlodipine in the Treatment of Severe Hypertension

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00136851
Enrollment
259
Registered
2005-08-29
Start date
2004-12-31
Completion date
2005-07-31
Last updated
2011-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Hypertension

Brief 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.

Interventions

DRUGamlodipine besylate/benazepril hydrochloride

Sponsors

Novartis Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years

Inclusion criteria

* Diagnosis of severe hypertension

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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—
Change from baseline in the mean sitting systolic blood pressure after 4 and 6 weeks—
Change from baseline in the mean sitting diastolic blood pressure after 4 and 6 weeks—
Percentage of subjects with swelling in legs or arms after 4 and 6 weeks—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026