Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
Study NCT ID:
NCT01057251
Status:
COMPLETED
Last Update Posted:
2012-01-11
First Post:
2010-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Nebivolol in Patients With Systolic Stage 2 Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'manfred.stapff@frx.com', 'phone': '201-427-8000', 'title': 'Manfred Stapff, MD, PhD', 'phoneExt': '8686', 'organization': 'Forest Research Institute'}, 'certainAgreement': {'otherDetails': 'All data generated in this study will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the study.\n\nPublication of the results by the Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected for a period of 10 months, from March 2010 to January 2011.', 'eventGroups': [{'id': 'EG000', 'title': 'Nebivolol', 'description': '5 mg, titrated to 20 mg, once daily oral administration', 'otherNumAtRisk': 290, 'otherNumAffected': 0, 'seriousNumAtRisk': 290, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Dose-matched placebo, once daily oral administration', 'otherNumAtRisk': 142, 'otherNumAffected': 0, 'seriousNumAtRisk': 142, 'seriousNumAffected': 3}], 'seriousEvents': [{'term': 'Myofascial pain syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 290, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 290, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 290, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 290, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Prostate Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 290, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Mean Seated Systolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol', 'description': '5 mg, titrated to 20 mg, once daily oral administration'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Dose-matched placebo, once daily oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '-18.2', 'spread': '16.7', 'groupId': 'OG000'}, {'value': '-12.3', 'spread': '17.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline Visit 1 (week 0) to Visit 4 (Week 6)', 'description': 'Office blood pressure measured at trough by automatic oscillometric device.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Mean Seated Diastolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol', 'description': '5 mg, titrated to 20 mg, once daily oral administration'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Dose-matched placebo, once daily oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.3', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '-5.7', 'spread': '11.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline (Week 0) to Visit 4 (Week 6)', 'description': 'Office blood pressure measured at trough by automatic oscillometric device.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nebivolol', 'description': '5 mg, titrated to 20 mg, once daily oral administration'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Dose-matched placebo, once daily oral administration'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '290'}, {'comment': 'The safety population is 142, as one patient was randomized, but never received study drug.', 'groupId': 'FG001', 'numSubjects': '143'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '262'}, {'groupId': 'FG001', 'numSubjects': '114'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '29'}]}], 'dropWithdraws': [{'type': 'Did not meet InclusionExclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Other Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Recruitment occured from March 2010 through October 2010 at 36 US sites.', 'preAssignmentDetails': 'A 4 week single-blind placebo washout phase was required for patients on anti-hypertensives at screening.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '432', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Nebivolol', 'description': '5 mg, titrated to 20 mg, once daily oral administration'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Dose-matched placebo, once daily oral administration'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '290', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '432', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.1', 'spread': '8.1', 'groupId': 'BG000'}, {'value': '49.7', 'spread': '9.0', 'groupId': 'BG001'}, {'value': '50.6', 'spread': '8.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '141', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '202', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '230', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '290', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '432', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 433}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-06', 'studyFirstSubmitDate': '2010-01-26', 'resultsFirstSubmitDate': '2011-12-06', 'studyFirstSubmitQcDate': '2010-01-26', 'lastUpdatePostDateStruct': {'date': '2012-01-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-12-06', 'studyFirstPostDateStruct': {'date': '2010-01-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Mean Seated Systolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy', 'timeFrame': 'Change from Baseline Visit 1 (week 0) to Visit 4 (Week 6)', 'description': 'Office blood pressure measured at trough by automatic oscillometric device.'}, {'measure': 'Change From Baseline in Mean Seated Diastolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy', 'timeFrame': 'Change from Baseline (Week 0) to Visit 4 (Week 6)', 'description': 'Office blood pressure measured at trough by automatic oscillometric device.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Nebivolol', 'Bystolic TM', 'Hypertension', 'Stage 2 Hypertension'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '23332366', 'type': 'DERIVED', 'citation': 'Lewin A, Punzi H, Luo X, Stapff M. Nebivolol monotherapy for patients with systolic stage II hypertension: results of a randomized, placebo-controlled trial. Clin Ther. 2013 Feb;35(2):142-52. doi: 10.1016/j.clinthera.2012.12.015. Epub 2013 Jan 15.'}]}, 'descriptionModule': {'briefSummary': 'The primary object of this study is to evaluate the efficacy and safety of 6 weeks of nebivolol monotherapy compared with placebo in patients with systolic stage 2 hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male of female, 18 to 64 years of age at screening\n* mean seated heart rate at least 60 bpm\n* diagnosed systolic stage 2 hypertension\n* unremarkable physical exam findings\n\nExclusion Criteria:\n\n* high risk due to secondary hypertension or former stage 3 hypertension by JNC6\n* concurrent conditions (reno, cardiovascular, obesity, thyroid, etc)\n* currently taking medication that cannot be stopped during the course of the study\n* participating other clinical trials\n* member of the study center personnel\n* documented drug abuse\n* contra indication to beta blocker\n* abnormal lab finding\n* poor compliance\n* other conditions judged by investigator that is not suitable for the study'}, 'identificationModule': {'nctId': 'NCT01057251', 'acronym': 'NEB-MD-20', 'briefTitle': 'Nebivolol in Patients With Systolic Stage 2 Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Forest Laboratories'}, 'officialTitle': 'Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Effect of 5 mg or 20 mg Nebivolol Once Daily on Blood Pressure in Patients With Systolic Stage 2 Hypertension', 'orgStudyIdInfo': {'id': 'NEB-MD-20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Nebivolol']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Nebivolol', 'type': 'DRUG', 'otherNames': ['Bystolic'], 'description': '5 mg, titrated to 20 mg, once daily oral administration', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '5 mg or 20 mg once daily, oral administration', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36535', 'city': 'Foley', 'state': 'Alabama', 'country': 'United States', 'facility': 'Forest Investigative Site 008', 'geoPoint': {'lat': 30.40659, 'lon': -87.6836}}, {'zip': '36117', 'city': 'Montgomery', 'state': 'Alabama', 'country': 'United States', 'facility': 'Forest Investigative Site 021', 'geoPoint': {'lat': 32.36681, 'lon': -86.29997}}, {'zip': '91710', 'city': 'Chino', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 006', 'geoPoint': {'lat': 34.01223, 'lon': -117.68894}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 002', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 004', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92591', 'city': 'Temecula', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 020', 'geoPoint': {'lat': 33.49364, 'lon': -117.14836}}, {'zip': '33134', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 028', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '32114', 'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 014', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 001', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33316', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 037', 'geoPoint': {'lat': 26.12231, 'lon': 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'facility': 'Forest Investigative Site 009', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30904', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Forest Investigative Site 031', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '83646', 'city': 'Meridian', 'state': 'Idaho', 'country': 'United States', 'facility': 'Forest Investigative Site 039', 'geoPoint': {'lat': 43.61211, 'lon': -116.39151}}, {'zip': '04210', 'city': 'Auburn', 'state': 'Maine', 'country': 'United States', 'facility': 'Forest Investigative Site 007', 'geoPoint': {'lat': 44.09785, 'lon': -70.23117}}, {'zip': '21204', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Forest Investigative Site 038', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21209', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Forest Investigative Site 011', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '20678', 'city': 'Prince Frederick', 'state': 'Maryland', 'country': 'United States', 'facility': 'Forest Investigative Site 029', 'geoPoint': {'lat': 38.5404, 'lon': -76.5844}}, {'zip': '49079', 'city': 'Paw Paw', 'state': 'Michigan', 'country': 'United States', 'facility': 'Forest Investigative Site 023', 'geoPoint': {'lat': 42.21782, 'lon': -85.89112}}, {'zip': '63033', 'city': 'Florissant', 'state': 'Missouri', 'country': 'United States', 'facility': 'Forest Investigative Site 005', 'geoPoint': {'lat': 38.78922, 'lon': -90.32261}}, {'zip': '89106', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Forest Investigative Site 041', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '10010', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Forest Investigative Site 040', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28601', 'city': 'Hickory', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Forest Investigative Site 012', 'geoPoint': {'lat': 35.73319, 'lon': -81.3412}}, {'zip': '28144', 'city': 'Salisbury', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Forest Investigative Site 027', 'geoPoint': {'lat': 35.67097, 'lon': -80.47423}}, {'zip': '19438', 'city': 'Harleysville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Forest Investigative Site 024', 'geoPoint': {'lat': 40.27955, 'lon': -75.38712}}, {'zip': '29407', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Forest Investigative Site 013', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Forest Investigative Site 035', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '29464', 'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Forest Investigative Site 018', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'zip': '29681', 'city': 'Simpsonville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Forest Investigative Site 022', 'geoPoint': {'lat': 34.73706, 'lon': -82.25428}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Forest Investigative Site 003', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '78404', 'city': 'Corpus Christi', 'state': 'Texas', 'country': 'United States', 'facility': 'Forest Investigative Site 032', 'geoPoint': {'lat': 27.80058, 'lon': -97.39638}}, {'zip': '23219', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Forest Investigative Site 025', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Manfred Stapff, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Forest Research Institute, a Subsidiary of Forest Laboratories Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Forest Laboratories', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}