- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00171366
A Study Comparing the Response of Patients With Hypertension to Amlodipine or Amlodipine Plus Benazepril.
April 5, 2016 updated by: Novartis
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
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 Overview
Study Type
Interventional
Enrollment (Actual)
1422
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Jersey
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E. Hanover, New Jersey, United States, 07936
- Novartis Pharmaceuticals
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Change from baseline in mean sitting diastolic blood pressure at week 6
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Secondary Outcome Measures
Outcome Measure |
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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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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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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2004
Primary Completion (Actual)
July 1, 2005
Study Completion (Actual)
July 1, 2005
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 15, 2005
Study Record Updates
Last Update Posted (Estimate)
April 6, 2016
Last Update Submitted That Met QC Criteria
April 5, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypertension
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Enzyme Inhibitors
- Protease Inhibitors
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Angiotensin-Converting Enzyme Inhibitors
- Amlodipine
- Benazepril
Other Study ID Numbers
- CCIB002H2304
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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China Academy of Chinese Medical SciencesGuang'anmen Hospital of China Academy of Chinese Medical SciencesCompletedHypertension, Resistant to Conventional Therapy | Primary HypertensionChina
Clinical Trials on amlodipine/benazepril
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Dr. Reddy's Laboratories LimitedCompleted
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Dr. Reddy's Laboratories LimitedCompleted
-
NovartisTerminatedHypertensionUnited States, Denmark, Finland, Norway, Sweden
-
NovartisCompleted
-
NovartisCompletedHypertension | Left Ventricular HypertrophyUnited States
-
NovartisCompleted
-
Novartis PharmaceuticalsCompleted
-
Dr. Reddy's Laboratories LimitedCompleted
-
Dr. Reddy's Laboratories LimitedCompleted
-
Teva Pharmaceuticals USACompleted