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

• ClinicalTrials.gov Identifier: NCT00158093
• Recruitment Status: Completed
• First Posted: September 12, 2005
• Last Update Posted: September 12, 2005
• Sponsor: Mylan Bertek Pharmaceuticals
• Information provided by: Mylan Bertek Pharmaceuticals

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hypertension	Drug: Nebivolol; Drug: Atenolol; Drug: Moxifloxacin	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 260 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: June 2003
• Study Completion Date: July 2003

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. 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 Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, Florida

SFBC International, Inc.

Miami, Florida, United States, 33181

Sponsors and Collaborators

Mylan Bertek Pharmaceuticals

Investigators

• Principal Investigator: Lawrence A Galitz, MD; SFBC International
• Study Director: Will A Sullivan, BS; Mylan Bertek Pharmaceuticals Inc.

More Information

• ClinicalTrials.gov Identifier: NCT00158093
• Other Study ID Numbers: NEB122
• First Posted: September 12, 2005
• Last Update Posted: September 12, 2005
• Last Verified: September 2005

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases; Moxifloxacin; Atenolol; Nebivolol; Anti-Bacterial Agents; Anti-Infective Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Physiological Effects of Drugs; Anti-Arrhythmia Agents; Antihypertensive Agents; Sympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic beta-1 Receptor Antagonists; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Vasodilator Agents; Adrenergic beta-1 Receptor Agonists; Adrenergic beta-Agonists; Adrenergic Agonists