Impact of Nebivolol on Central Aortic Pressure
Overview[ - collapse ][ - ]
| Purpose | A randomized, cross-over, single-blind study to compare the effects of nebivolol and metoprolol on central aortic pressure and peripheral brachial pressure in patients with stable cardiovascular disease. |
|---|---|
| Condition | Central Aortic Pressure |
| Intervention | Drug: Nebivolol Drug: Metoprolol |
| Phase | N/A |
| Sponsor | Creighton University |
| Responsible Party | Creighton University |
| ClinicalTrials.gov Identifier | NCT01051947 |
| First Received | January 19, 2010 |
| Last Updated | July 29, 2011 |
| Last verified | July 2011 |
Tracking Information[ + expand ][ + ]
| First Received Date | January 19, 2010 |
|---|---|
| Last Updated Date | July 29, 2011 |
| Start Date | December 2009 |
| Estimated Primary Completion Date | May 2010 |
| Current Primary Outcome Measures | Stable blood pressure [Time Frame: 6 months] [Designated as safety issue: No]Subjects will be randomized to nebivolol or metoprolol. Their medication will be titrated so that their blood pressure is within 10% of their initial reading. |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Impact of Nebivolol on Central Aortic Pressure |
|---|---|
| Official Title | Impact of Nebivolol on Central Aortic Pressure |
| Brief Summary | A randomized, cross-over, single-blind study to compare the effects of nebivolol and metoprolol on central aortic pressure and peripheral brachial pressure in patients with stable cardiovascular disease. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | N/A |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment |
| Condition | Central Aortic Pressure |
| Intervention | Drug: Nebivolol 10 mg by mouth daily for 2 weeks 20 mg by mouth daily for 2 weeks 40 mg by mouth daily for 2 weeks Drug: Metoprolol dosage prescribed prior to starting on study |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Withdrawn |
|---|---|
| Estimated Enrollment | Not Provided |
| Estimated Completion Date | May 2010 |
| Estimated Primary Completion Date | May 2010 |
| Eligibility Criteria | Inclusion Criteria: - Subjects with history of hypertension - Subjects who have received metoprolol for a minimum of 3 months Exclusion Criteria: - Patients who have had an acute myocardial infarction, coronary revascularization or who have been hospitalized for heart failure or cardiac arrhythmia in the past 6 months |
| Gender | Both |
| Ages | 45 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01051947 |
|---|---|
| Other Study ID Numbers | 08-15168 |
| Has Data Monitoring Committee | No |
| Information Provided By | Creighton University |
| Study Sponsor | Creighton University |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Jennifer Campbell, PharmD Creighton University |
| Verification Date | July 2011 |
Locations[ + expand ][ + ]
| The Cardiac Center at Creighton University | Omaha, Nebraska, United States, 68131 |
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