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

Sponsor:	Mylan Bertek Pharmaceuticals
Information provided by:	Mylan Bertek Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00158093

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 I

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:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Atenolol Nebivolol Moxifloxacin Moxifloxacin hydrochloride

U.S. FDA Resources

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

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
Vascular Diseases
Cardiovascular Diseases
Atenolol
Nebivolol
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Anti-Infective Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on February 09, 2012