Hypertension
Conditions
Brief summary
Nebivolol is one of a class of drugs known as beta-blockers. These drugs are useful in the treatment of high blood pressure, angina, abnormal heart rhythms and following a heart attack. The purpose of this study is to explore the potential of nebivolol to cause a certain type of abnormal heart rhythm, known as QTc prolongation. The potential of nebivolol to cause this adverse event will be compared to three other drugs: atenolol, a beta-blocker approved by the FDA; Avelox (moxifloxacin), an anti-biotic approved for use by the FDA which is known to cause QTc prolongation; and placebo, a drug look-alike that contains no drug. The working hypothesis was that 20 or 40 mg of nebivolol would not prolong corrected QT intervals measured during peak nebivolol concentrations (i.e., 2 hours after dosing) on Day 7.
Interventions
DRUGNebivolol
DRUGAtenolol
DRUGMoxifloxacin
Sponsors
Mylan Bertek Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Men and nonpregnant, nonlactating women were 18 years or older. * Women declaring postmenopausal or surgical sterility. * Women of childbearing potential who had a negative serum HCG within 2 weeks of dosing. * Male subjects weighed at least 60 kg (132 lb), and female subjects weighed at least 48 kg (106 lb). All volunteers weighed within 15% of their ideal body weight (IBW).
Exclusion criteria
* Institutionalized * Reported or was known to have done the following: * Used any tobacco product. * Ingested any alcoholic, caffeine or xanthine containing food or beverage within the 48 hours prior to the initial dose of study medication * Consumed grapefruit or grapefruit containing products within 7 days prior to the initial dose of study medication. * Ingested any vitamins or herbal products within the 48 hours prior to the initial dose of study medication. * Recently changed dietary or exercise habits significantly * Used any medication (including over-the-counter \[OTC\]) within the 14 days prior to the initial dose of study medication. * Used any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication. * Received an investigational drug within 30 days prior to the initial dose of study medication. * History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or neurologic disease. * History of drug and/or alcohol abuse within 1 year prior to the study. * Acute illness at the time of either the pre study medical evaluation or dosing. * Any laboratory results deemed clinically significant by the physician. * Abnormal and clinically relevant ECG tracing. * Donated or lost a significant volume of blood or plasma (\>450 mL) within 28 days prior to the initial dose of study medication. * Allergic or hypersensitive to nebivolol, atenolol, or other β blocking drugs or to moxifloxacin or other quinolone antibiotics. * History of seizures or cerebrovascular disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study endpoint was the change in the average QTc intervals from Day 0 to 2 hours after dosing on Day 7. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints were the change in average QTc intervals from Day 0 to all other evaluation times and the change in other ECG intervals (PR, RR, QRS, QT) and HR from Day 0 to all other evaluation times. | — |
Countries
United States
Outcome results
None listed