Status:
TERMINATED
The Impact of Nebivolol Versus Metoprolol on Quality of Life
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Forest Laboratories
Lahey Clinic
Conditions:
Transplant; Failure, Kidney
Hypertension
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
In an open label analysis, nebivolol has been shown to have a positive impact on quality of life in the general hypertensive population. That is, patients treated with nebivolol reported less side eff...
Eligibility Criteria
Inclusion
- Adult renal transplant recipients, men and women between 18 and 75 years of age, inclusive.
- Patients must be \> 3 months post-transplant.
- Patients must have stable renal function (stable renal function will be defined as those patients without infection or hospitalization \[for any reason\] over the past 30 days, and patients with \< 20% change in their serum creatinine over the past 30 days.
- Patients receiving corticosteroids must be receiving a daily dose of \< 7.5 mg of prednisone (or therapeutic equivalents based on glucocorticoid equivalency scale).
- All eligible patients must be receiving antihypertensive medication management which must include metoprolol tartrate or metoprolol succinate.
- Patients may be on more than one medication to control their hypertension. Use of any other FDA-approved antihypertensive agent is permitted.
- All eligible patients will either be at goal blood pressure (\<120/80 mmHg) or have Pre-hypertension (\<140/90 mmHg) or Stage I hypertension (\<160/100 mmHg) at the time of study inclusion.
- Patients who are able to comprehend and satisfactorily comply with protocol requirements.
- Patients who signed the written informed consent given prior to entering any study procedure.
Exclusion
- Patients with Stage II/uncontrolled hypertension (\>159/99 mmHg).
- Patients with an easily identifiable etiology for fatigue (i.e. anemia, iron-deficiency, poor sleep patterns, etc.).
- Patients who have a medical condition that, in the Investigator's opinion, would expose them to an increased risk of a significant adverse event or interfere with assessments of safety and efficacy during the course of the trial (i.e. arrhythmia).
- Patients with any current malignancy, or any clinically significant hematological, endocrine, cardiovascular, hepatic, gastrointestinal or neurological disease (including any form of epilepsy). If there is a history of such disease but the condition has been stable for at least the past year and is judged by the investigator not to interfere with the patient's participation in the study, the patient may be included.
- Patients who are judged by the investigator to be unable or unlikely to follow the study protocol and complete all scheduled visits.
- Patients with any contraindications to beta blocker therapy as listed in the package labeling for both metoprolol succinate and nebivolol.
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01441570
Start Date
February 1 2012
End Date
July 1 2013
Last Update
April 20 2017
Active Locations (2)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
2
Lahey Clinic
Burlington, Massachusetts, United States, 01805