Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-01-25 @ 1:15 AM
Study NCT ID:
NCT00596466
Status:
COMPLETED
Last Update Posted:
2021-01-26
First Post:
2008-01-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Extension Study Of Long-Term Safety And Efficacy Of Pregabalin As Monotherapy (Lyrica) In Patients With Partial Seizures
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D004828', 'term': 'Epilepsies, Partial'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069583', 'term': 'Pregabalin'}], 'ancestors': [{'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Pregabalin', 'description': 'Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment.', 'otherNumAtRisk': 73, 'otherNumAffected': 14, 'seriousNumAtRisk': 73, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}], 'seriousEvents': [{'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.1'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Seizure Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment.'}], 'timeFrame': 'Baseline up to Week 28', 'reportingStatus': 'POSTED', 'populationDescription': 'Not analyzed; Per protocol, seizure frequency data for individual participants were collected and reviewed but no statistical inferences were conducted because there was no comparator agent for this study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With (All Causality) Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment.'}], 'classes': [{'title': 'Non-serious AEs', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Serious AEs (SAEs)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 28', 'description': 'Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set population: all participants who received at least 1 dose of pregabalin.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Laboratory Test Values of Potential Clinical Importance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 28', 'description': 'Pre-defined criteria were established for each laboratory test (hematology, blood chemistry and urinalysis) to define the values that would be identified as of potential clinical importance.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set population; Number of participants analyzed (N): participants with at least one observation of any given laboratory test while on study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pregabalin', 'description': 'Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}]}, {'type': 'Enrolled, Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Unpecified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Enrolled, not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'Participants were eligible for the current study A0081160 (NCT00596466) if they adequately responded to pregabalin treatment in protocol A0081047 (NCT00524030).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Pregabalin', 'description': 'Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18-44 years', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}]}]}, {'title': '45-64 years', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}, {'title': 'Greater than or equal to (≥) 65 years', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-22', 'studyFirstSubmitDate': '2008-01-08', 'resultsFirstSubmitDate': '2012-06-22', 'studyFirstSubmitQcDate': '2008-01-08', 'lastUpdatePostDateStruct': {'date': '2021-01-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-08-10', 'studyFirstPostDateStruct': {'date': '2008-01-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Seizure Frequency', 'timeFrame': 'Baseline up to Week 28'}, {'measure': 'Number of Participants With (All Causality) Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Baseline up to Week 28', 'description': 'Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category.'}, {'measure': 'Number of Participants With Laboratory Test Values of Potential Clinical Importance', 'timeFrame': 'Baseline up to Week 28', 'description': 'Pre-defined criteria were established for each laboratory test (hematology, blood chemistry and urinalysis) to define the values that would be identified as of potential clinical importance.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['open-label', 'extension study', 'pregabalin', 'partial epilepsy'], 'conditions': ['Epilepsy']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the long term safety and efficacy of pregabalin (Lyrica) when administered by itself (without any other anti-epileptic medication) to epilepsy patients for the treatment of partial seizures. This is an extension study to a previous clinical trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Completed the previous protocol and wish to continue to receive pregabalin.\n* Diagnosis of epilepsy with partial seizures\n\nExclusion Criteria:\n\n* Early withdrawal from the previous protocol, an episode of status epliepticus, or primary generalized epilepsy.'}, 'identificationModule': {'nctId': 'NCT00596466', 'briefTitle': 'Extension Study Of Long-Term Safety And Efficacy Of Pregabalin As Monotherapy (Lyrica) In Patients With Partial Seizures', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'An Open-Label Multicenter Extension Study To Determine Long Term Safety And Efficacy Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures', 'orgStudyIdInfo': {'id': 'A0081160'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: pregabalin']}], 'interventions': [{'name': 'pregabalin', 'type': 'DRUG', 'description': 'pregabalin', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85003', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72703', 'city': 'Fayetteville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '95355', 'city': 'Modesto', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.6391, 'lon': -120.99688}}, {'zip': '92562', 'city': 'Murrieta', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.55391, 'lon': -117.21392}}, {'zip': '92660', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '92591', 'city': 'Temecula', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.49364, 'lon': -117.14836}}, {'zip': '80204', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '30024', 'city': 'Suwanee', 'state': 'Georgia', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.05149, 'lon': -84.0713}}, {'zip': '46122', 'city': 'Danville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.7606, 'lon': -86.52639}}, {'zip': '46805', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '42101', 'city': 'Bowling Green', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 36.99032, 'lon': -86.4436}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '70363', 'city': 'Houma', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 29.59577, 'lon': -90.71953}}, {'zip': '71105-5634', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '21208', 'city': 'Pikesville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.37427, 'lon': -76.72247}}, {'zip': '01608', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '39232', 'city': 'Flowood', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 32.30959, 'lon': -90.13898}}, {'zip': '59405', 'city': 'Great Falls', 'state': 'Montana', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 47.50024, 'lon': -111.30081}}, {'zip': '28203', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28209', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '73120', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77074', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '76508', 'city': 'Temple', 'state': 'Texas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 31.09823, 'lon': -97.34278}}, {'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84088', 'city': 'West Jordan', 'state': 'Utah', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.60967, 'lon': -111.9391}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '266 01', 'city': 'Beroun', 'country': 'Czechia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 49.96382, 'lon': 14.072}}, {'zip': '602 00', 'city': 'Brno', 'country': 'Czechia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '570 14', 'city': 'Litomyšl', 'country': 'Czechia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 49.86809, 'lon': 16.31298}}, {'city': 'New Territories', 'country': 'Hong Kong', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 22.42441, 'lon': 114.11095}}, {'zip': '49005', 'city': 'Dnipropetrovsk', 'country': 'Ukraine', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 48.46664, 'lon': 35.04066}}, {'zip': '49115', 'city': 'Dnipropetrovsk', 'country': 'Ukraine', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 48.46664, 'lon': 35.04066}}, {'zip': '61018', 'city': 'Kharkiv', 'country': 'Ukraine', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'zip': '61068', 'city': 'Kharkiv', 'country': 'Ukraine', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'zip': '91045', 'city': 'Luhansk', 'country': 'Ukraine', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 48.56814, 'lon': 39.30553}}, {'zip': '65025', 'city': 'Odesa', 'country': 'Ukraine', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 46.48572, 'lon': 30.74383}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Pfizer's Upjohn has merged with Mylan to form Viatris Inc.", 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}