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...
Date First Received: September 12, 2005
Last Updated: March 20, 2008
Verified by: Novartis, March 2008
Clinical Trial Phase: Phase 3 | Start Date: July 2004
Overall Status: Completed
Estimated Enrollment: 726
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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 Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: amlodipine/benazepril
Outcome Measures for this Clinical Trial
Primary Measures
- Change from baseline in mean sitting diastolic blood pressure at week 6
Secondary 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
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Clinical Trial Sponsor Information
Lead Sponsor: Novartis
Overall Clinical Trial Officials and Contacts
Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals
Additional Information
Information obtained from ClinicalTrials.gov on December 03, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00171366
Study ID Number: CCIB002H2304
ClinicalTrials.gov Identifier: NCT00171366
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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