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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00158093
• Date of registration: 07/09/2005
• Primary sponsor: Mylan Bertek Pharmaceuticals
• Public title: A Safety Evaluation of ECG Intervals and Blood Pressure in Normal Healthy Volunteers After Use of Nebivolol, Atenolol, Moxifloxacin, or Placebo
• Scientific 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
• Date of first enrolment: June 2003
• Target sample size: 260
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00158093
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Will A Sullivan, BS
• Affiliation: Mylan Bertek Pharmaceuticals Inc.

• Name: Lawrence A Galitz, MD
• Affiliation: SFBC International

Key inclusion & exclusion 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 ß blocking drugs or to
moxifloxacin or other quinolone antibiotics.

- History of seizures or cerebrovascular disease.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Hypertension

Intervention(s)

Drug: Atenolol

Drug: Moxifloxacin

Drug: Nebivolol

Primary Outcome(s)

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(s)

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.

Secondary ID(s)

NEB122

Source(s) of Monetary Support

Please refer to primary and secondary sponsors