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):
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
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:
Drug Information available for: Benazepril hydrochloride Benazepril Amlodipine Amlodipine besylate LotrelU.S. FDA Resources
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
|Study Start Date:||July 2004|
|Study Completion Date:||July 2005|
|Primary Completion Date:||July 2005 (Final data collection date for primary outcome measure)|
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00171366
|United States, New Jersey|
|E. Hanover, New Jersey, United States, 07936|
Sponsors and Collaborators
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|