Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT00309751
Status:
COMPLETED
Last Update Posted:
2010-02-23
First Post:
2005-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study Comparing Pitavastatin and Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C108475', 'term': 'pitavastatin'}, {'id': 'D000069059', 'term': 'Atorvastatin'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'barana@kowaus.com', 'phone': '919 433 1600', 'title': 'Bill Arana', 'organization': 'Kowa Research Institute Inc'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Pitavastatin 4 mg QD', 'description': 'Pitavastatin 4 mg once daily', 'otherNumAffected': 29, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Atorvastatin 20 mg QD', 'description': 'Atorvastatin 20 mg once daily', 'otherNumAffected': 22, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}], 'seriousEvents': [{'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Tachycardia paroxysmal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Alcohol poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Intervertebral disc disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline Low Density Lipoprotein Cholesterol (LDL-C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitavastatin 4 mg QD', 'description': 'Pitavastatin 4 mg once daily'}, {'id': 'OG001', 'title': 'Atorvastatin 20 mg QD', 'description': 'Atorvastatin 20 mg once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-40.78', 'spread': '19.599', 'groupId': 'OG000'}, {'value': '-43.25', 'spread': '16.378', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Percent change from baseline to Week 12 low density lipoprotein cholesterol (LDL-C)', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2009-08'}, {'type': 'SECONDARY', 'title': 'Number of Patients Attaining National Cholesterol Education Program (NCEP) LDL-C Target', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitavastatin 4 mg QD', 'description': 'Pitavastatin 4 mg once daily'}, {'id': 'OG001', 'title': 'Atorvastatin 20 mg QD', 'description': 'Atorvastatin 20 mg once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '212', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'Number of patients attaining National Cholesterol Education Program (NCEP)LDL-C target (LDL-C less than 160 mg/dL) at 12 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2009-08'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pitavastatin 4 mg QD', 'description': 'Pitavastatin 4 mg once daily'}, {'id': 'FG001', 'title': 'Atorvastatin 20 mg QD', 'description': 'Atorvastatin 20 mg once daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '279'}, {'groupId': 'FG001', 'numSubjects': '139'}]}, {'type': 'Safety Population', 'achievements': [{'comment': 'Subjects who received at least 1 dose of study drug', 'groupId': 'FG000', 'numSubjects': '275'}, {'comment': 'Subjects who received at least 1 dose of study drug', 'groupId': 'FG001', 'numSubjects': '137'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '248'}, {'groupId': 'FG001', 'numSubjects': '124'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '15'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '412', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pitavastatin 4 mg QD', 'description': 'Pitavastatin 4 mg once daily'}, {'id': 'BG001', 'title': 'Atorvastatin 20 mg QD', 'description': 'Atorvastatin 20 mg once daily'}, {'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': '191', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '284', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.1', 'spread': '9.21', 'groupId': 'BG000'}, {'value': '59.8', 'spread': '9.06', 'groupId': 'BG001'}, {'value': '59.4', 'spread': '9.15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '155', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '233', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 418}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-02-17', 'studyFirstSubmitDate': '2005-12-08', 'resultsFirstSubmitDate': '2009-08-26', 'studyFirstSubmitQcDate': '2006-03-31', 'lastUpdatePostDateStruct': {'date': '2010-02-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-12-11', 'studyFirstPostDateStruct': {'date': '2006-04-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline Low Density Lipoprotein Cholesterol (LDL-C)', 'timeFrame': '12 weeks', 'description': 'Percent change from baseline to Week 12 low density lipoprotein cholesterol (LDL-C)'}], 'secondaryOutcomes': [{'measure': 'Number of Patients Attaining National Cholesterol Education Program (NCEP) LDL-C Target', 'timeFrame': '12 weeks', 'description': 'Number of patients attaining National Cholesterol Education Program (NCEP)LDL-C target (LDL-C less than 160 mg/dL) at 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Kowa', 'Type II Diabetes Mellitus', 'Combined Dyslipidemia', 'pitavastatin', 'NK-104', 'Atorvastatin'], 'conditions': ['Type II Diabetes Mellitus', 'Dyslipidemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy and safety of pitavastatin with that of atorvastatin in patients with type II diabetes mellitus (type II DM) and combined dyslipidemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females (ages 18-75 years)\n* Type II DM treated with oral anti-diabetic medication (sulfonylurea, metformin, glitazones, or combination therapy)\n* Must have been following a restrictive diet\n* Diagnosis of combined dyslipidemia\n\nExclusion Criteria:\n\n* Homozygous familial hypercholesterolemia\n* Conditions which may cause secondary dyslipidemia\n* Uncontrolled diabetes mellitus\n* Abnormal pancreatic, liver, or renal function\n* Abnormal serum creatine kinase (CK) above the pre-specified level\n* Significant heart disease'}, 'identificationModule': {'nctId': 'NCT00309751', 'briefTitle': 'Study Comparing Pitavastatin and Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kowa Research Europe'}, 'officialTitle': 'Study of Pitavastatin Vs. Atorvastatin (Following Up-Titration) in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia', 'orgStudyIdInfo': {'id': 'NK-104-305'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pitavastatin 4 mg QD', 'description': 'Pitavastatin 4 mg once daily', 'interventionNames': ['Drug: Pitavastatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Atorvastatin 20 mg QD', 'description': 'Atorvastatin 20 mg once daily', 'interventionNames': ['Drug: Atorvastatin']}], 'interventions': [{'name': 'Pitavastatin', 'type': 'DRUG', 'description': 'Pitavastatin 4 mg QD', 'armGroupLabels': ['Pitavastatin 4 mg QD']}, {'name': 'Atorvastatin', 'type': 'DRUG', 'otherNames': ['Lipitor'], 'description': 'Atorvastatin 20 mg', 'armGroupLabels': ['Atorvastatin 20 mg QD']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aalborg', 'country': 'Denmark', 'facility': 'CCBR Aalborg', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'city': 'Ballerup Municipality', 'country': 'Denmark', 'facility': 'CCBR A/S', 'geoPoint': {'lat': 55.73165, 'lon': 12.36328}}, {'city': 'Vejle', 'country': 'Denmark', 'facility': 'CCBR Vejle', 'geoPoint': {'lat': 55.70927, 'lon': 9.5357}}, {'city': 'Berlin-Spandau', 'country': 'Germany', 'facility': 'Gemeinschaftspraxis am Bahnhof'}, {'city': 'Chemnitz', 'country': 'Germany', 'facility': 'Pharmakologisches Studienzentum Chemnitz', 'geoPoint': {'lat': 50.8357, 'lon': 12.92922}}, {'city': 'Frankfurt am Main', 'country': 'Germany', 'facility': 'Internistische Diabetische Schwerpunktpraxis Dr.', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'city': 'Mainz', 'country': 'Germany', 'facility': 'Internistische Gemeinschaftspraxis', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'city': 'Messkirch', 'country': 'Germany', 'facility': 'Gemeinschaftspraxis Dr. Senftleber, Dr. Kohler', 'geoPoint': {'lat': 47.99457, 'lon': 9.11479}}, {'city': 'Bangalore', 'country': 'India', 'facility': 'Bhagwan Mahaveer Jain Heart Centre', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'city': 'Chennai', 'country': 'India', 'facility': 'Sri Ramachandra Medical College Hospital', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'city': 'Hyderabaad', 'country': 'India', 'facility': 'Apollo Hospitals'}, {'city': 'Hyderabaad', 'country': 'India', 'facility': 'CARE Group of Hospitals'}, {'city': 'Mumbai', 'country': 'India', 'facility': 'PD Hinduja Hospital', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'city': 'Breda', 'country': 'Netherlands', 'facility': 'Andromed Breda', 'geoPoint': {'lat': 51.58656, 'lon': 4.77596}}, {'city': 'Eindhoven', 'country': 'Netherlands', 'facility': 'Andromed Eindhoven', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'city': 'Groningen', 'country': 'Netherlands', 'facility': 'Andromed Noord', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Andromed Leiden', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Andromed Nijmegen', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Andromed Rotterdam', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Velp', 'country': 'Netherlands', 'facility': 'Andromed Oost', 'geoPoint': {'lat': 51.995, 'lon': 5.97361}}, {'city': 'Zoetermeer', 'country': 'Netherlands', 'facility': 'Andromed Zoetermeer', 'geoPoint': {'lat': 52.0575, 'lon': 4.49306}}, {'city': 'Bialystok', 'country': 'Poland', 'facility': 'Podlaski Osrodek Kardiologii', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'city': 'Gruziadz', 'country': 'Poland', 'facility': 'NZOZ GCP Dobra Praktyka Lekaska'}, {'city': 'Katowice', 'country': 'Poland', 'facility': 'NZOZ Terapia Optima', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'city': 'Siedlce', 'country': 'Poland', 'facility': 'NZOZ Centrum, Poradnia Kardiologiczna', 'geoPoint': {'lat': 52.16772, 'lon': 22.29006}}, {'city': 'Tarnów', 'country': 'Poland', 'facility': 'Spec. Gab. Lek. Internistyczno-Kardiologicznly', 'geoPoint': {'lat': 50.01381, 'lon': 20.98698}}, {'city': 'Tychy', 'country': 'Poland', 'facility': 'Woj.Szp.Spec.Nr 1 im. Prof. J. Gasinskiego', 'geoPoint': {'lat': 50.13717, 'lon': 18.96641}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Instytut Zywnosci i Zywienia', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Lecznica PROSEN SMO', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Szpital Wolski,im. Dr A. Gostynskiej', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Łosice', 'country': 'Poland', 'facility': 'NZOZ Esculap, Przychodnia Lekary Rodzinnych', 'geoPoint': {'lat': 52.21129, 'lon': 22.71801}}, {'city': 'Berkshire', 'country': 'United Kingdom', 'facility': 'Synexus Reading Clinical Research Centre'}, {'city': 'Lancashire', 'country': 'United Kingdom', 'facility': 'Synexus Lancashire Clinical Research Centre'}, {'city': 'Liverpool', 'country': 'United Kingdom', 'facility': 'Synexus Merseyside Clinical Research Centre', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Synexus Manchester Clinical Research Centre', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Dragos Budinski, Med Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kowa Research Europe'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kowa Research Europe', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Dragos Budinski, MD', 'oldOrganization': 'Kowa Research Europe'}}}}