Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-26 @ 12:47 AM
Study NCT ID:
NCT00200460
Status:
COMPLETED
Last Update Posted:
2005-09-20
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study Evaluating the Effects of Nebivolol on Blood Pressure in Hypertensive Patients
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'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 825}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-09'}, 'statusVerifiedDate': '2005-09', 'completionDateStruct': {'date': '2003-03'}, 'lastUpdateSubmitDate': '2005-09-12', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change of the average sitting diastolic blood pressure taken at trough drug plasma level at the end of treatment compared to baseline'}], 'secondaryOutcomes': [{'measure': '- Sitting SBP'}, {'measure': '- Supine SBP and DBP'}, {'measure': '- Standing SBP and DBP'}, {'measure': '- Response rate'}, {'measure': '- Correlation between plasma levels'}]}, 'conditionsModule': {'keywords': ['Nebivolol', 'Hypertension', 'Beta-Blocker'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effects of various doses of nebivolol in patients with mild to moderate hypertension.', 'detailedDescription': 'This was a multi-center, randomized, double-blind, parallel group, placebo-controlled study of nebivolol over a range of doses in patients with mild to moderate hypertension. The study consisted of 2 phases: screening/washout/single-blind placebo run-in followed by randomization/double-blind treatment. During the double-blind phase, patients received nebivolol or placebo. Patients had 7 scheduled clinical visits during the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* An average sitting diastolic blood pressure of greater then or equal to 95 mmHg and less then or equal to 109 mmHg at baseline\n\nExclusion Criteria:\n\n* Recent myocardial infarction or stroke\n* Secondary hypertension\n* Contraindications to beta-blocker treatment or discontinuation of current antihypertensive therapy\n* Pregnancy, nursing, or women of child-bearing potential not using appropriate contraception'}, 'identificationModule': {'nctId': 'NCT00200460', 'briefTitle': 'A Study Evaluating the Effects of Nebivolol on Blood Pressure in Hypertensive Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mylan Bertek Pharmaceuticals'}, 'officialTitle': 'A Double-Blind, Multi-Center, Randomized, Placebo-Controlled, Parallel Group Dosing Study Evaluating the Effects of Nebivolol on Blood Pressure in Patients With Mild to Moderate Hypertension', 'orgStudyIdInfo': {'id': 'NEB302'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Nebivolol', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '26505', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'Mylan Pharmaceuticals Inc.', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}], 'overallOfficials': [{'name': 'Betty S. Riggs, MD, MBA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mylan Pharmaceuticals Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mylan Bertek Pharmaceuticals', 'class': 'INDUSTRY'}}}}