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A Study Comparing the Response of Patients With Hypertension to Amlodipine or Amlodipine Plus Benazepril.

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Novartis

Status and phase

Completed
Phase 3

Conditions

Hypertension

Treatments

Drug: amlodipine/benazepril

Study type

Interventional

Funder types

Industry

Identifiers

NCT00171366
CCIB002H2304

Details and patient eligibility

About

Comparison of the safety and efficacy of the combination of amlodipine/Benazepril to amlodipine monotherapy in patients with non-essential hypertension, not controlled on amlodipine alone.

Enrollment

1,422 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Outpatients 18 years of age or older.
  • Male or female patients are eligible. Female patients must be either post-menopausal for one year or surgically sterile, or using effective, contraceptive methods such as barrier method with spermicide, or an intrauterine device.
  • Patients with essential hypertension as measured by a validated device

Exclusion criteria

  • Severe hypertension (DBP > 115 mmHg diastolic and/or SBP > 180 mmHg systolic).

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

1

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Data sourced from clinicaltrials.gov

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