A Study Comparing the Response of Patients With Hypertension to Amlodipine or Amlodipine Plus Benazepril.
NCT00171366
ABOUT THIS STUDY
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Adult Trials: 18+ Years
- 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
- Severe hypertension (DBP > 115 mmHg diastolic and/or SBP > 180 mmHg systolic).
Other protocol-defined exclusion criteria may apply.
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| 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 | 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:
Exclusion Criteria:
Other protocol-defined exclusion criteria may apply. | |||
| Sex/Gender ICMJE |
| |||
| 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 |
| |||
| 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 | ||||