Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 11:36 PM
Study NCT ID:
NCT00158093
Status:
COMPLETED
Last Update Posted:
2005-09-12
First Post:
2005-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Safety Evaluation of ECG Intervals and Blood Pressure in Normal Healthy Volunteers After Use of Nebivolol, Atenolol, Moxifloxacin, or Placebo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068577', 'term': 'Nebivolol'}, {'id': 'D001262', 'term': 'Atenolol'}, {'id': 'D000077266', 'term': 'Moxifloxacin'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 260}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-06'}, 'statusVerifiedDate': '2005-09', 'completionDateStruct': {'date': '2003-07'}, 'lastUpdateSubmitDate': '2005-09-07', 'studyFirstSubmitDate': '2005-09-07', 'studyFirstSubmitQcDate': '2005-09-07', 'lastUpdatePostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary study endpoint was the change in the average QTc intervals from Day 0 to 2 hours after dosing on Day 7.'}], 'secondaryOutcomes': [{'measure': '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.'}]}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and nonpregnant, nonlactating women were 18 years or older.\n* Women declaring postmenopausal or surgical sterility.\n* Women of childbearing potential who had a negative serum HCG within 2 weeks of dosing.\n* 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).\n\nExclusion Criteria:\n\n* Institutionalized\n* Reported or was known to have done the following:\n\n * Used any tobacco product.\n * Ingested any alcoholic, caffeine or xanthine containing food or beverage within the 48 hours prior to the initial dose of study medication\n * Consumed grapefruit or grapefruit containing products within 7 days prior to the initial dose of study medication.\n * Ingested any vitamins or herbal products within the 48 hours prior to the initial dose of study medication.\n * Recently changed dietary or exercise habits significantly\n* Used any medication (including over-the-counter \\[OTC\\]) within the 14 days prior to the initial dose of study medication.\n* Used any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.\n* Received an investigational drug within 30 days prior to the initial dose of study medication.\n* History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or neurologic disease.\n* History of drug and/or alcohol abuse within 1 year prior to the study.\n* Acute illness at the time of either the pre study medical evaluation or dosing.\n* Any laboratory results deemed clinically significant by the physician.\n* Abnormal and clinically relevant ECG tracing.\n* Donated or lost a significant volume of blood or plasma (\\>450 mL) within 28 days prior to the initial dose of study medication.\n* Allergic or hypersensitive to nebivolol, atenolol, or other β blocking drugs or to moxifloxacin or other quinolone antibiotics.\n* History of seizures or cerebrovascular disease.'}, 'identificationModule': {'nctId': 'NCT00158093', 'briefTitle': 'A Safety Evaluation of ECG Intervals and Blood Pressure in Normal Healthy Volunteers After Use of Nebivolol, Atenolol, Moxifloxacin, or Placebo', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mylan Bertek Pharmaceuticals'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'NEB122'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Nebivolol', 'type': 'DRUG'}, {'name': 'Atenolol', 'type': 'DRUG'}, {'name': 'Moxifloxacin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33181', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'SFBC International, Inc.', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Lawrence A Galitz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SFBC International'}, {'name': 'Will A Sullivan, BS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mylan Bertek Pharmaceuticals Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mylan Bertek Pharmaceuticals', 'class': 'INDUSTRY'}}}}