Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-27 @ 9:25 PM
Study NCT ID:
NCT00770861
Status:
COMPLETED
Last Update Posted:
2011-01-26
First Post:
2008-10-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study on the Efficacy and Safety of Nebivolol Monotherapy in Hispanic Hypertensive Patients
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': 'John.Whalen@frx.com', 'phone': '1-201-427-8259', 'title': 'John Whalen, MD Executive Director of Clinical Development - Cardiovascular and Metabolism', 'organization': 'Forest Laboratories'}, 'certainAgreement': {'otherDetails': "Sponsor can review results communications prior to public release \\& can embargo communications re: results for 60 days from time submitted to sponsor for review. PI shall not disclose sponsor's confidential information. Upon sponsor's request, PI shall delete any proprietary info \\& shall not include raw data in the publication. On sponsor's request, PI shall delay submission for any pub while sponsor files patent applications. Any publication will give recognition to Sponsor's support.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events data were collected for a period of thirteen months, from November 2008 to December 2009.', 'eventGroups': [{'id': 'EG000', 'title': 'Nebivolol', 'description': 'Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets, oral administration', 'otherNumAtRisk': 141, 'otherNumAffected': 5, 'seriousNumAtRisk': 141, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Matching placebo tablets, oral administration', 'otherNumAtRisk': 136, 'otherNumAffected': 8, 'seriousNumAtRisk': 136, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 136, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'seriousEvents': [{'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Trough Seated DBP at Week 8(LOCF).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol', 'description': 'Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets, oral administration'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablets, oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.1', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '-7.3', 'spread': '8.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'H0 - There was no difference in BP reduction between Neb and Placebo. The efficacy analyses were based on the ITT population for the double-blind treatment phase. The LOCF was used to impute missing postbaseline values. Sensitivity analyses were based on observed cases for all efficacy parameters. All statistical tests were two-sided hypothesis tests performed at the 5% level of significance for main effects. All confidence intervals were two-sided 95% confidence intervals.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Between-treatment comparison of efficacy was performed by ANCOVA, with treatment, baseline BMI, center as factors \\& baseline value as a covariate.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (week 8)', 'description': 'The primary efficacy parameter was the change from baseline in mean trough seated DBP at Week 8. The average of three consecutive BP measurements would be the mean trough seated DBP value.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8 (LOCF).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol', 'description': 'Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets, oral administration'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablets, oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.1', 'spread': '12.7', 'groupId': 'OG000'}, {'value': '-9.3', 'spread': '13.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (week 8)', 'description': 'The secondary efficacy parameter was the change from baseline in mean trough seated SBP at Week 8. The average of three consecutive BP measurements would be the mean trough seated SBP value.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nebivolol', 'description': 'Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets, oral administration'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Matching placebo tablets, oral administration'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '141'}, {'groupId': 'FG001', 'numSubjects': '136'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '131'}, {'groupId': 'FG001', 'numSubjects': '120'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '16'}]}]}], 'recruitmentDetails': 'The recruitment period was one year, from November 2008 to November 2009, occurring at 29 centers in the US and 3 centers in Puerto Rico.', 'preAssignmentDetails': 'All patients went through a 4 week, single blind, placebo run-in/washout phase before randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '277', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Nebivolol', 'description': 'Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets, oral administration'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Matching placebo tablets, 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': '135', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '264', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.4', 'spread': '8.7', 'groupId': 'BG000'}, {'value': '50.4', 'spread': '8.7', 'groupId': 'BG001'}, {'value': '50.4', 'spread': '8.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '134', 'groupId': 'BG000'}, {'value': '131', 'groupId': 'BG001'}, {'value': '265', 'groupId': 'BG002'}]}]}, {'title': 'Puerto Rico', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', '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': 277}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'lastUpdateSubmitDate': '2010-12-21', 'studyFirstSubmitDate': '2008-10-09', 'resultsFirstSubmitDate': '2010-11-09', 'studyFirstSubmitQcDate': '2008-10-09', 'lastUpdatePostDateStruct': {'date': '2011-01-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-12-21', 'studyFirstPostDateStruct': {'date': '2008-10-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Trough Seated DBP at Week 8(LOCF).', 'timeFrame': 'From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (week 8)', 'description': 'The primary efficacy parameter was the change from baseline in mean trough seated DBP at Week 8. The average of three consecutive BP measurements would be the mean trough seated DBP value.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8 (LOCF).', 'timeFrame': 'From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (week 8)', 'description': 'The secondary efficacy parameter was the change from baseline in mean trough seated SBP at Week 8. The average of three consecutive BP measurements would be the mean trough seated SBP value.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['nebivolol', 'Bystolic ™', 'Hypertension', 'Hispanic', 'Hypertension in Hispanic patients'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy and safety of nebivolol monotherapy in Hispanic patients with stage 1 or stage 2 hypertension'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female outpatients 18 to 80 years of age, self-identified as Hispanic or Latino ethnicity\n* Females must be post-menopausal, or not pregnant and using an approved contraceptive regimen\n* Meet criteria for stage I or II hypertension\n* Currently not treated, or being treated with no more than two anti-hypertensive medications\n\nExclusion Criteria:\n\n* Secondary hypertension\n* Are taking three or more antihypertensive agents\n* Have uncontrolled or poorly controlled diabetes mellitus type I or type II\n* Evidence of other concurrent disease or conditions that might interfere with the conduct of the study\n* Participation in any investigational study within 30 days of Screening (Visit 1).\n* Have a history of hypersensitivity to nebivolol or other β-blockers, or any contraindication to β-blocker use'}, 'identificationModule': {'nctId': 'NCT00770861', 'briefTitle': 'A Study on the Efficacy and Safety of Nebivolol Monotherapy in Hispanic Hypertensive Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Forest Laboratories'}, 'officialTitle': 'A Multicenter, Prospective, Randomized, Double-blind, Placebo-Controlled, Dose-Titration Study of Nebivolol Monotherapy in Hispanic Patients With Stage 1 or Stage 2 Hypertension', 'orgStudyIdInfo': {'id': 'NEB-MD-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Nebivolol', 'description': 'Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets, oral administration', 'interventionNames': ['Drug: Nebivolol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching placebo tablets, oral administration', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Nebivolol', 'type': 'DRUG', 'otherNames': ['Bystolic (TM)'], 'description': 'Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets , oral administration Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration', 'armGroupLabels': ['Nebivolol']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo tablets, oral administration', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90620', 'city': 'Buena Park', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site', 'geoPoint': {'lat': 33.86751, 'lon': -117.99812}}, {'zip': '91710', 'city': 'Chino', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site', 'geoPoint': {'lat': 34.01223, 'lon': -117.68894}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91950', 'city': 'National City', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site', 'geoPoint': {'lat': 32.67811, 'lon': -117.0992}}, {'zip': '92404', 'city': 'San Bernardino', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site', 'geoPoint': {'lat': 34.10834, 'lon': -117.28977}}, {'zip': '92591', 'city': 'Temecula', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site', 'geoPoint': {'lat': 33.49364, 'lon': -117.14836}}, {'zip': '92780', 'city': 'Tustin', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site', 'geoPoint': {'lat': 33.74585, 'lon': -117.82617}}, {'zip': '33134', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '33012', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site FL2', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33012', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33016', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '34741', 'city': 'Kissimmee', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site', 'geoPoint': {'lat': 28.30468, 'lon': -81.41667}}, {'zip': '33014', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33169', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33183', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33024', 'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '33027', 'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30312', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Forest Investigative Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30338', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Forest Investigative Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '12553', 'city': 'New Windsor', 'state': 'New York', 'country': 'United States', 'facility': 'Forest Investigative Site', 'geoPoint': {'lat': 41.47676, 'lon': -74.02375}}, {'zip': '10451', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Forest Investigative Site', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '75006', 'city': 'Carrollton', 'state': 'Texas', 'country': 'United States', 'facility': 'Forest Investigative Site', 'geoPoint': {'lat': 32.95373, 'lon': -96.89028}}, {'zip': '78404', 'city': 'Corpus Christi', 'state': 'Texas', 'country': 'United States', 'facility': 'Forest Investigative Site', 'geoPoint': {'lat': 27.80058, 'lon': -97.39638}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Forest Investigative Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '79902', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'Forest Investigative Site', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'zip': '78224', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Forest Investigative Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Forest Investigative Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '00717', 'city': 'Ponce', 'country': 'Puerto Rico', 'facility': 'Forest Investigative Site', 'geoPoint': {'lat': 18.01031, 'lon': -66.62398}}, {'zip': '00751', 'city': 'Salinas', 'country': 'Puerto Rico', 'facility': 'Forest Investigative Site', 'geoPoint': {'lat': 17.97747, 'lon': -66.29795}}, {'zip': '00909', 'city': 'Santurce', 'country': 'Puerto Rico', 'facility': 'Forest Investigative Site', 'geoPoint': {'lat': 18.19523, 'lon': -67.14018}}], 'overallOfficials': [{'name': 'Tatjana Lukic, MD., M.Sc.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Forest Research Institute, a subsidiary of Forest Laboratories Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Forest Laboratories', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'John Whalen, MD, Executive Director, Clinical Development, Cardiovascular', 'oldOrganization': 'Forest Research Institute, a Subsidiary of Forest Laboratories Inc.'}}}}