Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-26 @ 2:05 AM
Study NCT ID:
NCT00272805
Status:
COMPLETED
Last Update Posted:
2013-02-18
First Post:
2006-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Drug Compliance and Quality of Life in Patients With Heart Failure Dosed With Either Once-daily or Twice-daily Coreg
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018487', 'term': 'Ventricular Dysfunction, Left'}], 'ancestors': [{'id': 'D018754', 'term': 'Ventricular Dysfunction'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077261', 'term': 'Carvedilol'}], 'ancestors': [{'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-15', 'studyFirstSubmitDate': '2006-01-05', 'studyFirstSubmitQcDate': '2006-01-05', 'lastUpdatePostDateStruct': {'date': '2013-02-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dosing compliance: pill taking total taken vs number prescribed'}], 'secondaryOutcomes': [{'measure': 'quality of life'}]}, 'conditionsModule': {'keywords': ['chronic heart failure', 'left ventricular systolic dysfunction'], 'conditions': ['Chronic Heart Failure']}, 'referencesModule': {'references': [{'pmid': '19477398', 'type': 'DERIVED', 'citation': 'Udelson JE, Pressler SJ, Sackner-Bernstein J, Massaro J, Ordronneau P, Lukas MA, Hauptman PJ. Adherence with once daily versus twice daily carvedilol in patients with heart failure: the Compliance And Quality of Life Study Comparing Once-Daily Controlled-Release Carvedilol CR and Twice-Daily Immediate-Release Carvedilol IR in Patients with Heart Failure (CASPER) Trial. J Card Fail. 2009 Jun;15(5):385-93. doi: 10.1016/j.cardfail.2008.12.010. Epub 2009 Feb 12.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare dosing compliance between study patients taking controlled release carvedilol once a day, and study patients taking immediate release carvedilol (Coreg) twice a day.', 'detailedDescription': 'Study Further Study Details:\n\nPrimary outcome: pill-taking compliance (total doses taken versus total doses prescribed)\n\nExpected Total Enrollment: 400 subjects at 56 study sites in the U.S.\n\nStudy Start: October 2005\n\nThis is a 5-month double-blind treatment study of male and female subjects with stable mild-to-severe chronic heart failure and with left ventricular dysfunction with symptoms of heart failure.\n\nEligibility:\n\nMust be stable on treatment with Coreg IR at a standard dose: 6.25, 12.5, 25 mg twice a day.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to read English\n* Stable symptoms of mild to severe heart failure\n* Stable medical regimen for heart failure\n* On a stable dose of Coreg for at least 2 months\n* LVEF ≤40% within the previous 24 months\n\nExclusion Criteria:\n\n* Uncorrected obstructive or regurgitant valve disease\n* Complex congenital heart disease\n* Recent ICD or pacemaker placement\n* Recent coronary artery bypass surgery or stroke\n* Candidate for heart transplanct within 5 months of study start\n* Present or planned use of MAO inhibitors, alfpha-blockers, combined alpha-beta blockers, any Class I/II anti-arrythmnic agents, (amiodarone may be used if ≤ 200mg/day). Use of intravenous vasodilator/inotropic agents.'}, 'identificationModule': {'nctId': 'NCT00272805', 'briefTitle': 'Drug Compliance and Quality of Life in Patients With Heart Failure Dosed With Either Once-daily or Twice-daily Coreg', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cardiovascular Clinical Sciences Inc'}, 'officialTitle': 'Prospective, Randomized, Controlled Assessment of Once-Daily Controlled Release COREG CR vs Twice-Daily COREG Immediate Release(IR)on Measures of Compliance and Quality of Life in Patients With Heart Failure and Left Ventricular Systolic Dysfunction', 'orgStudyIdInfo': {'id': 'CCS 2005-001'}, 'secondaryIdInfos': [{'id': 'CASPER'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'carvedilol', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'The Heart Group', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85635', 'city': 'Sierra Vista', 'state': 'Arizona', 'country': 'United States', 'facility': 'Radiant Research', 'geoPoint': {'lat': 31.55454, 'lon': -110.30369}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Cardiology Consultants of Orange County', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '90210', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Access Clinical Trials', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '94609', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Cardiovascular Consultants Medical Group', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '34203', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'San Diego Cardiac Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '95403', 'city': 'Santa Rosa', 'state': 'California', 'country': 'United States', 'facility': 'Northern California Medical Associates', 'geoPoint': {'lat': 38.44047, 'lon': -122.71443}}, {'zip': '95405', 'city': 'Santa Rosa', 'state': 'California', 'country': 'United States', 'facility': 'Radiant Research', 'geoPoint': {'lat': 38.44047, 'lon': -122.71443}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Cardiovascular Consultants Medical Group', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '80528', 'city': 'Fort Collins', 'state': 'Colorado', 'country': 'United States', 'facility': 'Heart Center of the Rockies', 'geoPoint': {'lat': 40.58526, 'lon': -105.08442}}, {'zip': '06105', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'St. Francis Hospital and Medical Center', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '33126', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'NextPhase Clinical Trials', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33952', 'city': 'Port Charlotte', 'state': 'Florida', 'country': 'United States', 'facility': 'Charlotte Heart Group Research Center', 'geoPoint': {'lat': 26.97617, 'lon': -82.09064}}, {'zip': '33701', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'The Heart and Vascular Institute of Florida', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Cardiac Disease Specialists', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30901', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'CVMS Research Institute of Augusta', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '30014', 'city': 'Covington', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Heart Specialists', 'geoPoint': {'lat': 33.59678, 'lon': -83.86018}}, {'zip': '83704', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Idaho Cardiology Associates', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '60015', 'city': 'Bannockburn', 'state': 'Illinois', 'country': 'United States', 'facility': 'North Shore Cardiologists', 'geoPoint': {'lat': 42.19336, 'lon': -87.86646}}, {'zip': '60148', 'city': 'Lombard', 'state': 'Illinois', 'country': 'United States', 'facility': 'Midwest Heart Foundation', 'geoPoint': {'lat': 41.88003, 'lon': -88.00784}}, {'zip': '61761', 'city': 'Normal', 'state': 'Illinois', 'country': 'United States', 'facility': 'Illinois Heart and Lung Research Center', 'geoPoint': {'lat': 40.5142, 'lon': -88.99063}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'The Care Group', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Clinical Trials Management', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '04210', 'city': 'Auburn', 'state': 'Maine', 'country': 'United States', 'facility': 'Androscoggin Cardiology Associates-Research', 'geoPoint': {'lat': 44.09785, 'lon': -70.23117}}, {'zip': '04106', 'city': 'S.Portland', 'state': 'Maine', 'country': 'United States', 'facility': 'Maine Cardiology Associates'}, {'zip': '04074', 'city': 'Scarborough', 'state': 'Maine', 'country': 'United States', 'facility': 'Cardiovascular Consultants of Maine', 'geoPoint': {'lat': 43.57814, 'lon': -70.32172}}, {'zip': '01432', 'city': 'Ayer', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Primary Care Cardiology Research', 'geoPoint': {'lat': 42.5612, 'lon': -71.58979}}, {'zip': '01805', 'city': 'Burlington', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Lahey Clinic Cardiology', 'geoPoint': {'lat': 42.50482, 'lon': -71.19561}}, {'zip': '01830', 'city': 'Haverhill', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Pentucket Medical Associates', 'geoPoint': {'lat': 42.7762, 'lon': -71.07728}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '68516', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Bryan LGH Heart Institute', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '89128', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Lovelace Scientific Resources', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '08034', 'city': 'Cherry Hill', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Associated Cardiovascular Consultants', 'geoPoint': {'lat': 39.93484, 'lon': -75.03073}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico Health Science Center', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '12205', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Associates in Cardiology', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '11530', 'city': 'Garden City', 'state': 'New York', 'country': 'United States', 'facility': 'Cardiovascular Medical Associates', 'geoPoint': {'lat': 40.72677, 'lon': -73.6343}}, {'zip': '12401', 'city': 'Kingston', 'state': 'New York', 'country': 'United States', 'facility': 'MidValley Cardiology', 'geoPoint': {'lat': 41.92704, 'lon': -73.99736}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University Medical School', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11795', 'city': 'West Islip', 'state': 'New York', 'country': 'United States', 'facility': 'South Bay Cardiovascular Associates', 'geoPoint': {'lat': 40.70621, 'lon': -73.30623}}, {'zip': '27215', 'city': 'Burlington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Alamance Regional Medical Center', 'geoPoint': {'lat': 36.09569, 'lon': -79.4378}}, {'zip': '44307', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': 'Akron General Medical Center', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Lindner Clinical Trial Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45242', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'New Horizons Clinical Research', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45414', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Dayton Heart Center', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '44503', 'city': 'Lorain', 'state': 'Ohio', 'country': 'United States', 'facility': 'North Ohio Research Ltd.', 'geoPoint': {'lat': 41.45282, 'lon': -82.18237}}, {'zip': '44870', 'city': 'Sandusky', 'state': 'Ohio', 'country': 'United States', 'facility': 'North Ohio Research Ltd.', 'geoPoint': {'lat': 41.44894, 'lon': -82.70796}}, {'zip': '74006', 'city': 'Bartlesville', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Blue Stem Cardiology', 'geoPoint': {'lat': 36.74731, 'lon': -95.98082}}, {'zip': '97330', 'city': 'Corvallis', 'state': 'Oregon', 'country': 'United States', 'facility': 'Cardiovascular Consultants of Oregon', 'geoPoint': {'lat': 44.56457, 'lon': -123.26204}}, {'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Medical Group Clinical Research', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '18840', 'city': 'Sayre', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Guthrie Clinic Ltd.', 'geoPoint': {'lat': 41.97896, 'lon': -76.5155}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Rhode Island Heart Failure Center', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '75605', 'city': 'Longview', 'state': 'Texas', 'country': 'United States', 'facility': 'DCOL Center for Clinical Research', 'geoPoint': {'lat': 32.5007, 'lon': -94.74049}}, {'zip': '84143', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'LDS Hospital Cardiovascular Research', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '53121', 'city': 'Elkhorn', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Arrythmia Center for Southern Wisconsin', 'geoPoint': {'lat': 42.67279, 'lon': -88.54454}}], 'overallOfficials': [{'name': 'James E. Udelson, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiovascular Clinical Studies, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardiovascular Clinical Sciences Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}