A Safety Evaluation of ECG Intervals and Blood Pressure in Normal Healthy Volunteers After Use of Nebivolol, Atenolol, Moxifloxacin, or Placebo

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Parallel Group Safety Evaluation of Electrocardiographic Intervals and Blood Pressure in Normal Healthy Volunteers After Nebivolol, Atenolol, Moxifloxacin, or Placebo Administration After Single and Repeated Doses

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Nebivolol
* Drug: Atenolol
* Drug: Moxifloxacin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nebivolol|nan|
|Drug: Atenolol|nan|
|Drug: Moxifloxacin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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. |  |  |