Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-25 @ 9:10 PM
Study NCT ID:
NCT00882856
Status:
COMPLETED
Last Update Posted:
2017-01-09
First Post:
2009-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treating Clozapine-induced Sinustachycardia With Bisoprolol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009202', 'term': 'Cardiomyopathies'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017298', 'term': 'Bisoprolol'}], 'ancestors': [{'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-06', 'studyFirstSubmitDate': '2009-04-16', 'studyFirstSubmitQcDate': '2009-04-16', 'lastUpdatePostDateStruct': {'date': '2017-01-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart rate variability', 'timeFrame': 'Baseline, visit 1+2+3'}], 'secondaryOutcomes': [{'measure': 'QTc, T-wave morphology and other ECG markers', 'timeFrame': 'Baseline, visit 1+2+3'}, {'measure': 'Hamilton-Anxiety scale', 'timeFrame': 'Baseline, visit 1+2+3'}, {'measure': 'Salivation rate', 'timeFrame': 'Baseline, visit 1+2+3'}, {'measure': 'Orthostatic blood pressure', 'timeFrame': 'Baseline, visit 1+2+3'}, {'measure': 'WHO-QoL', 'timeFrame': 'Baseline, visit 1+2+3'}, {'measure': 'Nocturnal Hypersalivation Rating Scale (NHRS).', 'timeFrame': 'Baseline, visit 1+2+3'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Clozapine', 'Sinustachycardia', 'Heartrate variability', 'Cardiomyopathy'], 'conditions': ['Clozapine-induced Sinustachycardia']}, 'descriptionModule': {'briefSummary': 'Clozapine-induced sinustachycardia occurs in 25% of patients treated with clozapine and sustained sinustachycardia might be a risk factor for dilated cardiomyopathy. This double-blinded cross over placebo controlled study investigate whether 10 mg bisoprolol are efficient in treating clozapine-induced sinustachycardia measured as heart rate, heart rate variability, QTc and T-wave morphology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Treated with clozapine \\> 3 months and minimum 100 mg/day\n* Fixed dose 14 days before inclusion\n* Heart rate \\> 100 (ECG)\n* Pregnancy test negative\n* Clozapine-induced sinustachycardia documented by ECG or case record\n* Sexual abstinence or contraception\n* Informed consent\n\nExclusion Criteria:\n\n* Substance abuse\n* Physical diseases, contraindications for clozapine or bisoprolol\n* Asthma or chronic obstructive lung disease\n* Blood pressure \\< 100/60 or recent history of syncopes\n* QTc\\>500 ms, SA-block, AV- block II or III\n* Restrictions by Danish mental act\n* Allergic to clozapine or bisoprolol'}, 'identificationModule': {'nctId': 'NCT00882856', 'acronym': 'Biscloz', 'briefTitle': 'Treating Clozapine-induced Sinustachycardia With Bisoprolol', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Treating Clozapine-induced Sinustachycardia With Bisoprolol - a Double Blinded Placebo Controlled Cross Over Study', 'orgStudyIdInfo': {'id': '2009-09215-22/5.1. 22AUG2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bisoprolol-washout -placebo', 'description': 'Bisoprolol - wash out - placebo', 'interventionNames': ['Drug: Bisoprolol', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo - wash out - bisoprolol', 'description': 'Placebo - wash out - bisoprolol', 'interventionNames': ['Drug: Bisoprolol', 'Drug: Placebo']}], 'interventions': [{'name': 'Bisoprolol', 'type': 'DRUG', 'otherNames': ['Bisoprolol "Vitabalans"'], 'description': 'Bisoprolol "Vitabalnas" 10 mg once daily', 'armGroupLabels': ['Bisoprolol-washout -placebo', 'Placebo - wash out - bisoprolol']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo', 'armGroupLabels': ['Bisoprolol-washout -placebo', 'Placebo - wash out - bisoprolol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Aalborg University Hospital, Psychiatry', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}], 'overallOfficials': [{'name': 'Ole Schjerning, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aalborg University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aalborg University Hospital', 'class': 'OTHER'}, {'name': 'Aalborg University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}