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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
ClinicalTrials.gov processed this data on August 23, 2015
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: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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
Last updated: September 7, 2005

Page last updated: August 23, 2015

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