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

September 7, 2005
September 7, 2005
June 2003
Not Provided
The primary study endpoint was the change in the average QTc intervals from Day 0 to 2 hours after dosing on Day 7.
Same as current
No Changes Posted
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.
Same as current
Not Provided
Not Provided
 
A Safety Evaluation of ECG Intervals and Blood Pressure in Normal Healthy Volunteers After Use of Nebivolol, Atenolol, Moxifloxacin, or Placebo
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
  • Drug: Nebivolol
  • Drug: Atenolol
  • Drug: Moxifloxacin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
260
July 2003
Not Provided

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00158093
NEB122
Not Provided
Not Provided
Mylan Bertek Pharmaceuticals
Not Provided
Principal Investigator: Lawrence A Galitz, MD SFBC International
Study Director: Will A Sullivan, BS Mylan Bertek Pharmaceuticals Inc.
Mylan Bertek Pharmaceuticals
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP