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

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Novartis

Status and phase

Completed
Phase 4

Conditions

Hypertension

Treatments

Drug: amlodipine besylate/benazepril hydrochloride

Study type

Interventional

Funder types

Industry

Identifiers

NCT00136851
CCIB002FUS19

Details and patient eligibility

About

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.

Enrollment

259 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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 exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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