A Safety Evaluation of ECG Intervals and Blood Pressure in Normal Healthy Volunteers After Use of Nebivolol, Atenolol, Moxifloxacin, or Placebo
Information source: Mylan Bertek Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Nebivolol (Drug); Atenolol (Drug); Moxifloxacin (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Mylan Bertek Pharmaceuticals Official(s) and/or principal investigator(s):
Lawrence A Galitz, MD, Principal Investigator, Affiliation: SFBC International
Will A Sullivan, BS, Study Director, Affiliation: Mylan Bertek Pharmaceuticals Inc.
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.
Clinical Details
Official title: 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
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Primary outcome: 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: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
SFBC International, Inc., Miami, Florida 33181, United States
Additional Information
Starting date: June 2003
Ending date: July 2003
Last updated: September 7, 2005
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