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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):
Novartis Identifier:
First received: September 12, 2005
Last updated: April 5, 2016
Last verified: April 2016
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
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   (Adult, Senior)
Sexes Eligible for Study:   All

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 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

Responsible Party: Novartis Identifier: NCT00171366     History of Changes
Other Study ID Numbers: CCIB002H2304
Study First Received: September 12, 2005
Last Updated: April 5, 2016

Keywords provided by Novartis:

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Vasodilator Agents processed this record on May 22, 2017