Hypertension Clinical Trial
Official title:
Nebivolol Vs. Metoprolol: Comparative Effects on Fatigue and Quality of Life
Verified date | October 2018 |
Source | Weill Medical College of Cornell University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Beta-blockers are prescribed to millions of people for treatment of hypertension. Fatigue is
a recognized and common side effect of beta-blockers that can have significant effects on
quality of life. Worse, many people taking a beta-blocker for years are not even aware of the
reduction of energy with which they are living.
A new vasodilating beta-blocker, nebivolol, which is approved by the FDA for treatment of
hypertension, appears to be far less associated with fatigue than are most currently
available beta-blockers. The purpose of this study is to compare nebivolol with the current
best-selling beta-blocker, metoprolol, and determine whether there is a significant
difference in side effects including fatigue, reduced exertion tolerance, and reduced quality
of life.
In this study, 30 subjects will take each of the 2 study drugs for 8 weeks, consisting of 4
weeks at a lower dose, and 4 weeks at a higher dose. All dosages are FDA-approved for
treatment of hypertension. Subjects and investigators will not know which drug is being
administered until completion of the study. Subjects will undergo a treadmill stress test and
will complete fatigue and quality of life questionnaires after each 4 weeks of treatment. An
echocardiogram and non-invasive measurement of aortic blood pressure will be performed after
8 weeks on each drug. Also, blood will be drawn and stored for possible measurement of drug
levels, after 4 and 8 weeks on each drug. Results on each drug will then be compared. If
nebivolol is found to cause significantly less fatigue, it would be of substantial importance
to the many millions of people who are on life-long beta-blocker therapy, and are living with
reduced energy.
Status | Completed |
Enrollment | 37 |
Est. completion date | January 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Individuals who are taking, or are about to begin taking, a beta-blocker, and who have the approved indication of hypertension Exclusion Criteria: - Orthopedic ailments that would interfere with performance of treadmill testing - Stroke or heart attack within the previous 1 year - Symptomatic coronary disease within the past year (angina, shortness of breath) - Clinically significant pulmonary disease (e.g. emphysema or asthma). - Poorly controlled hypertension (blood pressure above 160 systolic or 100 diastolic) - Patients with contra-indications to taking a beta-blocker (asthma or bradyarrhythmia) - History of tachyarrhythmia (abnormal rapid heart rate) |
Country | Name | City | State |
---|---|---|---|
United States | Weill Cornell Medical College | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University | Forest Laboratories |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Multidimensional Assessment of Fatigue (MAF) Questionnaire: Global Fatigue Score After 4 Weeks of Treatment on Each Drug/Dose Combination. | A 16 item scale that measures 4 dimensions of fatigue: severity, distress, timing, and degree of interference in activities of daily living. Range: 1 (no fatigue) to 50 (extreme fatigue). |
After 4 weeks of treatment on each drug/dose combination | |
Primary | Treadmill Exercise Time After 4 Weeks of Treatment on Each Drug/Dose Combination. | Treadmill Exercise Time After 4 Weeks of Treatment on Each Drug/Dose Combination (in minutes). The Treadmill Test was Performed at the 4-week Visit of Each Drug/Dose Combination. | After 4 weeks of treatment on each drug/dose combination |
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