Comparing the Effects of Two Beta Blockers,Metoprolol and Nebivolol,on Ambulatory Blood Pressure and Basal Metabolic Rate
Overview[ - collapse ][ - ]
| Purpose | The purpose of the study is to compare the effects of nebivolol and metoprolol on 24-hour ambulatory blood pressure characteristics and basal metabolic rates in patients with hypertension. |
|---|---|
| Condition | Hypertension |
| Intervention | Drug: Metoprolol Drug: Nebivolol |
| Phase | N/A |
| Sponsor | University of Mississippi Medical Center |
| Responsible Party | University of Mississippi Medical Center |
| ClinicalTrials.gov Identifier | NCT00849810 |
| First Received | February 2, 2009 |
| Last Updated | March 18, 2013 |
| Last verified | March 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | February 2, 2009 |
|---|---|
| Last Updated Date | March 18, 2013 |
| Start Date | January 2009 |
| Estimated Primary Completion Date | November 2010 |
| Current Primary Outcome Measures | Primary Outcome is Pre- and Post-treatment Ambulatory Blood Pressure. [Time Frame: 4 weeks (pre- and post-treatment)] [Designated as safety issue: Yes] |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Comparing the Effects of Two Beta Blockers,Metoprolol and Nebivolol,on Ambulatory Blood Pressure and Basal Metabolic Rate |
|---|---|
| Official Title | Comparative Effects of Nebivolol Versus Metoprolol on 24-hour Blood Pressures and Basal Metabolic Rate: An Open-Label Study |
| Brief Summary | The purpose of the study is to compare the effects of nebivolol and metoprolol on 24-hour ambulatory blood pressure characteristics and basal metabolic rates in patients with hypertension. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | N/A |
| Study Design | Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Hypertension |
| Intervention | Drug: Metoprolol Metoprolol tablets 25-200 mg daily times four weeks. Nebivolol daily for 4-5 weeks Other Names:
5 - 20 mg daily, at a stable dose for 4 to 5 weeks |
| Study Arm (s) | Experimental: Metoprolol to nebivolol metoprolol 25-200mg at a stable daily dose for 4 weeks, then change to nebivolol at a comparable stable dose (5-20 mg) for 4 -5 weeks. |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Terminated |
|---|---|
| Estimated Enrollment | 1 |
| Estimated Completion Date | November 2010 |
| Estimated Primary Completion Date | November 2010 |
| Eligibility Criteria | Inclusion Criteria: - 18 years old or older - currently be treated at a University of MS Medical Center Internal Medicine Clinics - currently taking metoprolol succinate for hypertension - have their hypertension controlled (<140/90). Exclusion Criteria: - uncontrolled hypertension - severe renal or moderate hepatic impairment - currently taking CYP 2D6 inducers/inhibitors - recent stroke (less than 6 months) - recent myocardial infarction (less than 6 months) - congestive heart failure - diagnosed obstructive sleep apnea - atrial fibrillation - arm circumference >50 cm |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00849810 |
|---|---|
| Other Study ID Numbers | 2009-0002 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | University of Mississippi Medical Center |
| Study Sponsor | University of Mississippi Medical Center |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Deborah Minor, PharmD University of Mississippi Medical Center |
| Verification Date | March 2013 |
Locations[ + expand ][ + ]
| University of Mississippi Medical Center | Jackson, Mississippi, United States, 39216 |
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