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

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: September 12, 2005
Last updated: November 7, 2011
Last verified: November 2011

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.

Condition Intervention Phase
Drug: amlodipine/benazepril
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multicenter, Group Study to Evaluate the Safety and Efficacy of Amlodipine and Benazepril Administered in Combination Compared to Amlodipine Monotherapy in Hypertensive Patients Not Adequately Controlled With Amlodipine Alone

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline in mean sitting diastolic blood pressure at week 6

Secondary Outcome Measures:
  • Change from baseline in mean sitting systolic blood pressure at week 6
  • Change from week 2 in mean sitting diastolic and systolic blood pressure at week 6
  • Diastolic response rate at week 6. Patients were considered responders if they had a mean sitting diastolic blood pressure of < 90 mmHg or a >= 10 mm Hg decrease compared to baseline.
  • Change from baseline in 24 hour diastolic and systolic blood pressure at week 6
  • Change from baseline in 24 hour diastolic and systolic blood pressure at peak which is defined as the lowest hourly blood pressure mean and the average of the hourly means from 4 to 6 hours post dose at week 6

Enrollment: 1422
Study Start Date: July 2004
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both

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.

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00171366

United States, New Jersey
Novartis Pharmaceuticals
E. Hanover, New Jersey, United States, 07936
Sponsors and Collaborators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00171366     History of Changes
Other Study ID Numbers: CCIB002H2304
Study First Received: September 12, 2005
Last Updated: November 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:

Additional relevant MeSH terms:
Cardiovascular Diseases
Vascular Diseases
Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents
Calcium Channel Blockers
Cardiovascular Agents
Enzyme Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 20, 2014