Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT00102518
Status:
COMPLETED
Last Update Posted:
2012-08-31
First Post:
2005-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Aripiprazole Open-Label, Safety and Tolerability Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D000087122', 'term': 'Mania'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068180', 'term': 'Aripiprazole'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Margaretta.nyilas@otsuka-us.com', 'phone': '609-452-5673', 'title': 'Margaretta Nyilas', 'organization': 'Otsuka Pharmaceutical Development & Commercialization, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': "Adverse event data were collected as spontaneous reports at all scheduled visit. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.", 'description': 'Spontaneously reported at each visit in response to query of "How have you felt since your last assessment?"', 'eventGroups': [{'id': 'EG000', 'title': 'NCT00102063 and NCT00110461 Subjects', 'description': 'All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.', 'otherNumAtRisk': 325, 'otherNumAffected': 230, 'seriousNumAtRisk': 325, 'seriousNumAffected': 20}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 25}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Increased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 15}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 27}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Extrapyramidal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 48}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 31}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 42}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 26}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}], 'seriousEvents': [{'term': 'Bronchitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Hepatitis A', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Electrocution', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Intentional overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Acute psychosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Aggression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Bipolar disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Hallucination, auditory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Homicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Impulsive behavior', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Intentional self injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects Experiencing SAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NCT00102063 and NCT00110461 Subjects', 'description': 'All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 23', 'description': 'Percentage of Subjects Experiencing SAEs. The incidences of SAEs are summarized by system organ class in CT-8.5.1; by system organ class and MedDRA preferred term and by system organ class, MedDRA preferred term, and severity.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled subjects.'}, {'type': 'SECONDARY', 'title': 'Change in Change in Positive and Negative Syndrome Scale (PANSS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NCT00102063 and NCT00110461 Subjects', 'description': 'All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.5', 'spread': '17.89', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 26', 'description': 'Change from baseline to the last scheduled post-baseline evaluation in PANSS total score, using observed cases (assessments performed at baseline and weeks 4, 12, and 26).\n\nThis scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point scale of severity with 1 being absent to 7 being extreme. Minimum score is 30 which is best outcome; maximum score is 210 for worse outcome.', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Young Mania Rating Scale (Y-MRS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NCT00102063 and NCT00110461 Subjects', 'description': 'All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.74', 'spread': '11.73', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 26', 'description': 'Change from baseline to last scheduled post-baseline evaluation in YMRS total score, using observed cases (assessments performed at baseline and weeks 4, 12, and 26).\n\nThe Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms).', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NCT00102063 and NCT00110461 Subjects', 'description': 'All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '325'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '238'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '87'}]}]}], 'recruitmentDetails': 'Participants were recruited from 157 centers in Argentina, Bulgaria, Croatia, India, Jamaica, Mexico, Romania, Russia, Serbia, South Africa, South Korea, Ukraine, and the United States between September 2004 and February 2007. A total of 325 subjects were screened for enrollment and all 325 subjects were enrolled.', 'preAssignmentDetails': 'All participants had previously completed NCT00102063 (OPDC 31-03-239, adolescents with schizophrenia) or had withdrawn from the double-blind extension phase of NCT00110461 (OPDC 31-03-240, children and adolescents with bipolar 1 disorder), both clinical studies of aripiprazole.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'NCT00102063 and NCT00110461 Subjects', 'description': 'All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '15.02', 'spread': '1.89', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '140', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '185', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '44', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '281', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '206', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '45', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '164.09', 'spread': '11.22', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '63.19', 'spread': '17.86', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '23.25', 'spread': '5.21', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 325}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-31', 'studyFirstSubmitDate': '2005-01-29', 'resultsFirstSubmitDate': '2012-05-16', 'studyFirstSubmitQcDate': '2005-01-28', 'lastUpdatePostDateStruct': {'date': '2012-08-31', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-07-31', 'studyFirstPostDateStruct': {'date': '2005-01-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects Experiencing SAEs', 'timeFrame': 'Baseline and Week 23', 'description': 'Percentage of Subjects Experiencing SAEs. The incidences of SAEs are summarized by system organ class in CT-8.5.1; by system organ class and MedDRA preferred term and by system organ class, MedDRA preferred term, and severity.'}], 'secondaryOutcomes': [{'measure': 'Change in Change in Positive and Negative Syndrome Scale (PANSS) Total Score', 'timeFrame': 'Baseline and Week 26', 'description': 'Change from baseline to the last scheduled post-baseline evaluation in PANSS total score, using observed cases (assessments performed at baseline and weeks 4, 12, and 26).\n\nThis scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point scale of severity with 1 being absent to 7 being extreme. Minimum score is 30 which is best outcome; maximum score is 210 for worse outcome.'}, {'measure': 'Change in Young Mania Rating Scale (Y-MRS) Total Score', 'timeFrame': 'Baseline and Week 26', 'description': 'Change from baseline to last scheduled post-baseline evaluation in YMRS total score, using observed cases (assessments performed at baseline and weeks 4, 12, and 26).\n\nThe Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms).'}]}, 'conditionsModule': {'keywords': ['Open Label', 'Aripiprazole', 'Bipolar I Disorder, Manic or Mixed Episode'], 'conditions': ['Schizophrenia', 'Bipolar Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the long-term safety and tolerability of aripiprazole in adolescent patients with schizophrenia, and child and adolescent patients with bipolar I disorder, manic or mixed episode.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adolescent patients with schizophrenia, or child and adolescent patients with bipolar I disorder, manic or mixed episode\n\nExclusion Criteria:\n\n* Patients with a co-morbid serious, uncontrolled systemic illness\n* Patients with a significant risk of committing suicide'}, 'identificationModule': {'nctId': 'NCT00102518', 'acronym': 'APEX 241', 'briefTitle': 'Aripiprazole Open-Label, Safety and Tolerability Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Otsuka Pharmaceutical Development & Commercialization, Inc.'}, 'officialTitle': 'A Multi-Center, Open-Label, Safety and Tolerability Study of Flexible-Dose Oral Aripiprazole (2 Mg-30 mg) in the Treatment of Adolescent Patients With Schizophrenia and Child and Adolescent Patients With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features', 'orgStudyIdInfo': {'id': '31-03-241'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NCT00102063 and NCT00110461 Subjects', 'description': 'All subjects had either completed or had withdrawn from the double-blind extension phase of study NCT00110461 (OPDC 31-03-240) and study NCT00102063 (OPDC 31-03-239).', 'interventionNames': ['Drug: Aripiprazole']}], 'interventions': [{'name': 'Aripiprazole', 'type': 'DRUG', 'otherNames': ['OPC-14597'], 'description': '2 to 30 mg/day orally (2, 5, 10, 15, 20, 25, or 30 mg/day); tablets in strengths of 2, 5, 10, and 15 mg were used to achieve desired doses', 'armGroupLabels': ['NCT00102063 and NCT00110461 Subjects']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'city': 'Costa Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.64113, 'lon': -117.91867}}, {'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'city': 'Riverside', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'city': 'Rosemead', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.08057, 'lon': -118.07285}}, {'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'city': 'Temecula', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.49364, 'lon': -117.14836}}, {'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'city': 'Altamonte Springs', 'state': 'Florida', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 28.66111, 'lon': -81.36562}}, {'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Orange City', 'state': 'Florida', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 28.94888, 'lon': -81.29867}}, {'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'city': 'Lake Charles', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 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