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

NCT00171366

Last updated date
Study Location
Novartis Pharmaceuticals
E. Hanover, New Jersey, 07936, United States
Contact
1-800-718-1021

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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Severe hypertension (DBP > 115 mmHg diastolic and/or SBP > 180 mmHg systolic).


Other protocol-defined exclusion criteria may apply.

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Pfizer Clinical Trials Contact Center

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[email protected]

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Comparing the Response of Patients With Hypertension to Amlodipine or Amlodipine Plus Benazepril.
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE Drug: amlodipine/benazepril
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 7, 2011)
1422
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE July 2005
Actual Primary Completion Date July 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00171366
Other Study ID Numbers  ICMJE CCIB002H2304
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis
Study Sponsor  ICMJE Novartis
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Novartis PharmaceuticalsNovartis Pharmaceuticals
PRS Account Novartis
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP