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A Study Comparing the Response of Patients With Hypertension to Amlodipine or Amlodipine Plus Benazepril.

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ClinicalTrials.gov Identifier: NCT00171366
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : April 6, 2016
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Novartis

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Hypertension Drug: amlodipine/benazepril Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1422 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : July 2004
Actual Primary Completion Date : July 2005
Actual Study Completion Date : July 2005

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in mean sitting diastolic blood pressure at week 6

Secondary Outcome Measures :
  1. Change from baseline in mean sitting systolic blood pressure at week 6
  2. Change from week 2 in mean sitting diastolic and systolic blood pressure at week 6
  3. 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.
  4. Change from baseline in 24 hour diastolic and systolic blood pressure at week 6
  5. 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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00171366


Locations
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United States, New Jersey
Novartis Pharmaceuticals
E. Hanover, New Jersey, United States, 07936
Sponsors and Collaborators
Novartis
Pfizer
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00171366    
Other Study ID Numbers: CCIB002H2304
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: April 2016
Keywords provided by Novartis:
amlodipine
benazepril
hypertension
diastolic
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Benazepril
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
 Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors