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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00171366 |
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Date of registration:
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12/09/2005 |
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Primary sponsor: |
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Public title:
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A Study Comparing the Response of Patients With Hypertension to Amlodipine or Amlodipine Plus Benazepril.
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Scientific title:
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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 |
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Date of first enrolment:
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July 2004 |
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Target sample size:
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1422 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00171366 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Novartis Pharmaceuticals |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Pharmaceuticals |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypertension
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Intervention(s)
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Drug: amlodipine/benazepril
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Primary Outcome(s)
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Change from baseline in mean sitting diastolic blood pressure at week 6
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Secondary Outcome(s)
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Change from baseline in 24 hour diastolic and systolic blood pressure at week 6
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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
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Change from baseline in mean sitting systolic blood pressure at week 6
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Change from week 2 in mean sitting diastolic and systolic blood pressure at week 6
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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.
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Secondary ID(s)
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CCIB002H2304
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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