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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

This study has been completed.
Sponsor:
Information provided by:
Mylan Bertek Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00158093
First received: September 7, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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 Intervention Phase
Hypertension
Drug: Nebivolol
Drug: Atenolol
Drug: Moxifloxacin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Mylan Bertek Pharmaceuticals:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 260
Study Start Date: June 2003
Estimated Study Completion Date: July 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00158093

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

No publications provided

ClinicalTrials.gov Identifier: NCT00158093     History of Changes
Other Study ID Numbers: NEB122
Study First Received: September 7, 2005
Last Updated: September 7, 2005
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Atenolol
Moxifloxacin
Nebivolol
Norgestimate, ethinyl estradiol drug combination
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antihypertensive Agents
Antineoplastic Agents
Autonomic Agents
Cardiovascular Agents
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Combined
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Sympatholytics

ClinicalTrials.gov processed this record on November 25, 2014