Viewing Study NCT00413634

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Ignite Creation Date: 2025-12-25 @ 2:23 AM
Ignite Modification Date: 2025-12-27 @ 1:20 PM
Study NCT ID: NCT00413634
Status: COMPLETED
Last Update Posted: 2021-06-29
First Post: 2006-12-19
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: The Pharmacokinetics of Anagrelide in Elderly and Young Patients With Essential Thrombocythaemia (ET)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013920', 'term': 'Thrombocythemia, Essential'}], 'ancestors': [{'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D013922', 'term': 'Thrombocytosis'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C021139', 'term': 'anagrelide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTransparency@shire.com', 'phone': '+1 866 842 5335', 'title': 'Study Director', 'organization': 'Shire'}, 'certainAgreement': {'otherDetails': 'If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Agrylin (Young)', 'description': 'Anagrelide hydrochloride in ages 18-50 years', 'otherNumAtRisk': 12, 'otherNumAffected': 3, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Agrylin (Elderly)', 'description': 'Anagrelide hydrochloride in ages 65 and older', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Plasma Concentration (Cmax) of Agrylin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Agrylin (Young)', 'description': 'Anagrelide hydrochloride in ages 18-50 years'}, {'id': 'OG001', 'title': 'Agrylin (Elderly)', 'description': 'Anagrelide hydrochloride in ages 65 and older'}], 'classes': [{'categories': [{'measurements': [{'value': '2.66', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '3.63', 'spread': '1.44', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.092', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'over 1 day', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population (defined as all patients with post-dose drug concentration data)'}, {'type': 'SECONDARY', 'title': 'Platelet Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Agrylin (Young)', 'description': 'Anagrelide hydrochloride in ages 18-50 years'}, {'id': 'OG001', 'title': 'Agrylin (Elderly)', 'description': 'Anagrelide hydrochloride in ages 65 and older'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '488.8', 'spread': '167.4', 'groupId': 'OG000'}, {'value': '548.5', 'spread': '278.7', 'groupId': 'OG001'}]}]}, {'title': '2 hours post-dose', 'categories': [{'measurements': [{'value': '487.9', 'spread': '168.1', 'groupId': 'OG000'}, {'value': '539.2', 'spread': '258.6', 'groupId': 'OG001'}]}]}, {'title': '12 hours post-dose', 'categories': [{'measurements': [{'value': '473.2', 'spread': '146.0', 'groupId': 'OG000'}, {'value': '540.3', 'spread': '263.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'over 1 day', 'description': 'Platelet counts in patients with ET receiving Agrylin', 'unitOfMeasure': 'x 1,000,000,000/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population (defined as all patients who received study treatment)'}, {'type': 'SECONDARY', 'title': 'Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Agrylin (Young)', 'description': 'Anagrelide hydrochloride in ages 18-50 years'}, {'id': 'OG001', 'title': 'Agrylin (Elderly)', 'description': 'Anagrelide hydrochloride in ages 65 and older'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '74.0', 'spread': '9.6', 'groupId': 'OG000'}, {'value': '70.3', 'spread': '8.4', 'groupId': 'OG001'}]}]}, {'title': '0.5 hours post-dose', 'categories': [{'measurements': [{'value': '72.4', 'spread': '8.9', 'groupId': 'OG000'}, {'value': '77.7', 'spread': '13.5', 'groupId': 'OG001'}]}]}, {'title': '1 hour post-dose', 'categories': [{'measurements': [{'value': '75.8', 'spread': '5.5', 'groupId': 'OG000'}, {'value': '80.6', 'spread': '11.7', 'groupId': 'OG001'}]}]}, {'title': '1.5 hours post-dose', 'categories': [{'measurements': [{'value': '78.1', 'spread': '7.7', 'groupId': 'OG000'}, {'value': '82.7', 'spread': '12.9', 'groupId': 'OG001'}]}]}, {'title': '2 hours post-dose', 'categories': [{'measurements': [{'value': '74.3', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '81.2', 'spread': '13.8', 'groupId': 'OG001'}]}]}, {'title': '4 hours post-dose', 'categories': [{'measurements': [{'value': '75.0', 'spread': '5.5', 'groupId': 'OG000'}, {'value': '74.7', 'spread': '13.7', 'groupId': 'OG001'}]}]}, {'title': '6 hours post-dose', 'categories': [{'measurements': [{'value': '75.9', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '76.9', 'spread': '11.4', 'groupId': 'OG001'}]}]}, {'title': '8 hours post-dose', 'categories': [{'measurements': [{'value': '75.5', 'spread': '6.7', 'groupId': 'OG000'}, {'value': '76.3', 'spread': '10.1', 'groupId': 'OG001'}]}]}, {'title': '12 hours post-dose', 'categories': [{'measurements': [{'value': '73.2', 'spread': '6.0', 'groupId': 'OG000'}, {'value': '71.9', 'spread': '8.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'over 1 day', 'description': 'Heart rates in patients with ET receiving Agrylin', 'unitOfMeasure': 'beats/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'PRIMARY', 'title': 'Time of Maximum Plasma Concentration (Tmax) of Agrylin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Agrylin (Young)', 'description': 'Anagrelide hydrochloride in ages 18-50 years'}, {'id': 'OG001', 'title': 'Agrylin (Elderly)', 'description': 'Anagrelide hydrochloride in ages 65 and older'}], 'classes': [{'categories': [{'measurements': [{'value': '1.11', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '1.14', 'spread': '0.91', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.857', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'over 1 day', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'PRIMARY', 'title': 'Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Agrylin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Agrylin (Young)', 'description': 'Anagrelide hydrochloride in ages 18-50 years'}, {'id': 'OG001', 'title': 'Agrylin (Elderly)', 'description': 'Anagrelide hydrochloride in ages 65 and older'}], 'classes': [{'categories': [{'measurements': [{'value': '6.4', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '10.3', 'spread': '4.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.013', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'over 1 day', 'unitOfMeasure': 'ng.h/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'PRIMARY', 'title': 'Terminal Half-life (T 1/2) of Agrylin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Agrylin (Young)', 'description': 'Anagrelide hydrochloride in ages 18-50 years'}, {'id': 'OG001', 'title': 'Agrylin (Elderly)', 'description': 'Anagrelide hydrochloride in ages 65 and older'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.378', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'over 1 day', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'PRIMARY', 'title': 'Total Clearance (CL/F) of Agrylin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Agrylin (Young)', 'description': 'Anagrelide hydrochloride in ages 18-50 years'}, {'id': 'OG001', 'title': 'Agrylin (Elderly)', 'description': 'Anagrelide hydrochloride in ages 65 and older'}], 'classes': [{'categories': [{'measurements': [{'value': '156', 'spread': '73', 'groupId': 'OG000'}, {'value': '97', 'spread': '70', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.013', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'over 1 day', 'unitOfMeasure': 'L/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'PRIMARY', 'title': 'Volume of Distribution (Vz/F) of Agrylin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Agrylin (Young)', 'description': 'Anagrelide hydrochloride in ages 18-50 years'}, {'id': 'OG001', 'title': 'Agrylin (Elderly)', 'description': 'Anagrelide hydrochloride in ages 65 and older'}], 'classes': [{'categories': [{'measurements': [{'value': '286', 'spread': '125', 'groupId': 'OG000'}, {'value': '195', 'spread': '137', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.035', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'over 1 day', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'PRIMARY', 'title': 'Cmax of Active Metabolite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Agrylin (Young)', 'description': 'Active metabolite of Agrylin (BCH24426) in ages 18-50'}, {'id': 'OG001', 'title': 'Agrylin (Elderly)', 'description': 'Active metabolite of Agrylin (BCH24426) in ages 65 and older'}], 'classes': [{'categories': [{'measurements': [{'value': '7.26', 'spread': '3.74', 'groupId': 'OG000'}, {'value': '4.19', 'spread': '3.47', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.023', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'over 1 day', 'description': 'An active metabolite has therapeutic activity similar to the parent compound and must be considered in therapeutic pharmacokinetics.', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'PRIMARY', 'title': 'Tmax of Active Metabolite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Agrylin (Young)', 'description': 'Active metabolite of Agrylin (BCH24426) in ages 18-50'}, {'id': 'OG001', 'title': 'Agrylin (Elderly)', 'description': 'Active metabolite of Agrylin (BCH24426) in ages 65 and older'}], 'classes': [{'categories': [{'measurements': [{'value': '0.92', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '1.04', 'spread': '0.99', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.557', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'over 1 day', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'PRIMARY', 'title': 'AUC of Active Metabolite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Agrylin (Young)', 'description': 'Active metabolite of Agrylin (BCH24426) in ages 18-50'}, {'id': 'OG001', 'title': 'Agrylin (Elderly)', 'description': 'Active metabolite of Agrylin (BCH24426) in ages 65 and older'}], 'classes': [{'categories': [{'measurements': [{'value': '27.6', 'spread': '10.9', 'groupId': 'OG000'}, {'value': '17.4', 'spread': '14.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.027', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'over 1 day', 'unitOfMeasure': 'ng.h/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'PRIMARY', 'title': 'T 1/2 of Active Metabolite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Agrylin (Young)', 'description': 'Active metabolite of Agrylin (BCH24426) in ages 18-50'}, {'id': 'OG001', 'title': 'Agrylin (Elderly)', 'description': 'Active metabolite of Agrylin (BCH24426) in ages 65 and older'}], 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'over 1 day', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'PRIMARY', 'title': 'CL/F of Active Metabolite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Agrylin (Young)', 'description': 'Active metabolite of Agrylin (BCH24426) in ages 18-50'}, {'id': 'OG001', 'title': 'Agrylin (Elderly)', 'description': 'Active metabolite of Agrylin (BCH24426) in ages 65 and older'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'spread': '16', 'groupId': 'OG000'}, {'value': '57', 'spread': '27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.027', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'over 1 day', 'unitOfMeasure': 'L/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'PRIMARY', 'title': 'Vz/F of Active Metabolite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Agrylin (Young)', 'description': 'Active metabolite of Agrylin (BCH24426) in ages 18-50'}, {'id': 'OG001', 'title': 'Agrylin (Elderly)', 'description': 'Active metabolite of Agrylin (BCH24426) in ages 65 and older'}], 'classes': [{'categories': [{'measurements': [{'value': '139', 'spread': '86', 'groupId': 'OG000'}, {'value': '277', 'spread': '203', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.011', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'over 1 day', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Agrylin (Young)', 'description': 'Anagrelide hydrochloride in ages 18-50 years'}, {'id': 'OG001', 'title': 'Agrylin (Elderly)', 'description': 'Anagrelide hydrochloride in ages 65 and older'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '122.2', 'spread': '9.6', 'groupId': 'OG000'}, {'value': '154.3', 'spread': '19.6', 'groupId': 'OG001'}]}]}, {'title': '0.5 hours post-dose', 'categories': [{'measurements': [{'value': '122.7', 'spread': '12.9', 'groupId': 'OG000'}, {'value': '145.2', 'spread': '20.3', 'groupId': 'OG001'}]}]}, {'title': '1.0 hours post-dose', 'categories': [{'measurements': [{'value': '121.8', 'spread': '11.7', 'groupId': 'OG000'}, {'value': '143.7', 'spread': '21.8', 'groupId': 'OG001'}]}]}, {'title': '1.5 hours post-dose', 'categories': [{'measurements': [{'value': '122.3', 'spread': '11.6', 'groupId': 'OG000'}, {'value': '140.1', 'spread': '17.7', 'groupId': 'OG001'}]}]}, {'title': '2 hours post-dose', 'categories': [{'measurements': [{'value': '121.3', 'spread': '12.3', 'groupId': 'OG000'}, {'value': '139.9', 'spread': '19.8', 'groupId': 'OG001'}]}]}, {'title': '4 hours post-dose', 'categories': [{'measurements': [{'value': '122.2', 'spread': '13.6', 'groupId': 'OG000'}, {'value': '133.7', 'spread': '18.1', 'groupId': 'OG001'}]}]}, {'title': '6 hours post-dose', 'categories': [{'measurements': [{'value': '120.2', 'spread': '16.1', 'groupId': 'OG000'}, {'value': '141.8', 'spread': '19.5', 'groupId': 'OG001'}]}]}, {'title': '8 hours post-dose', 'categories': [{'measurements': [{'value': '123.6', 'spread': '14.5', 'groupId': 'OG000'}, {'value': '136.3', 'spread': '24.3', 'groupId': 'OG001'}]}]}, {'title': '12 hours post-dose', 'categories': [{'measurements': [{'value': '124.7', 'spread': '13.6', 'groupId': 'OG000'}, {'value': '159.8', 'spread': '28.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'over 1 day', 'description': 'Systolic blood pressures in patients with ET receiving Agrylin', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'SECONDARY', 'title': 'Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Agrylin (Young)', 'description': 'Anagrelide hydrochloride in ages 18-50 years'}, {'id': 'OG001', 'title': 'Agrylin (Elderly)', 'description': 'Anagrelide hydrochloride in ages 65 and older'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '76.9', 'spread': '7.5', 'groupId': 'OG000'}, {'value': '81.4', 'spread': '10.3', 'groupId': 'OG001'}]}]}, {'title': '0.5 hours post-dose', 'categories': [{'measurements': [{'value': '74.8', 'spread': '7.3', 'groupId': 'OG000'}, {'value': '75.2', 'spread': '9.9', 'groupId': 'OG001'}]}]}, {'title': '1 hour post-dose', 'categories': [{'measurements': [{'value': '72.4', 'spread': '6.6', 'groupId': 'OG000'}, {'value': '72.6', 'spread': '7.5', 'groupId': 'OG001'}]}]}, {'title': '1.5 hours post-dose', 'categories': [{'measurements': [{'value': '72.8', 'spread': '6.7', 'groupId': 'OG000'}, {'value': '71.6', 'spread': '9.5', 'groupId': 'OG001'}]}]}, {'title': '2 hours post-dose', 'categories': [{'measurements': [{'value': '71.3', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '72.8', 'spread': '7.1', 'groupId': 'OG001'}]}]}, {'title': '4 hours post-dose', 'categories': [{'measurements': [{'value': '76.2', 'spread': '6.0', 'groupId': 'OG000'}, {'value': '73.0', 'spread': '9.5', 'groupId': 'OG001'}]}]}, {'title': '6 hours post-dose', 'categories': [{'measurements': [{'value': '73.4', 'spread': '10.0', 'groupId': 'OG000'}, {'value': '71.3', 'spread': '7.6', 'groupId': 'OG001'}]}]}, {'title': '8 hours post-dose', 'categories': [{'measurements': [{'value': '76.3', 'spread': '6.2', 'groupId': 'OG000'}, {'value': '75.0', 'spread': '11.3', 'groupId': 'OG001'}]}]}, {'title': '12 hours post-dose', 'categories': [{'measurements': [{'value': '76.3', 'spread': '9.1', 'groupId': 'OG000'}, {'value': '84.2', 'spread': '12.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'over 1 day', 'description': 'Diastolic blood pressures in patients with ET receiving Agrylin', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Agrylin (Young)', 'description': 'Anagrelide hydrochloride in ages 18-50 years'}, {'id': 'FG001', 'title': 'Agrylin (Elderly)', 'description': 'Anagrelide hydrochloride in ages 65 and older'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients were between 18-50 years (young) and 65 or older (elderly) with a diagnosis of essential thrombocythemia (ET) and receiving a stable dose of anagrelide \\<=5mg/day for at least 4 weeks.', 'preAssignmentDetails': 'The study comprised four phases: Screening (patients take their normal regimen of anagrelide), a run-in period (patients divided their normal anagrelide daily dose equally into two daily doses), Pharmacokinetics (PK) sampling day (patients take normal morning dose), and follow-up (patients were contacted by phone 30 days after PK visit).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Agrylin (Young)', 'description': 'Anagrelide hydrochloride in ages 18-50 years'}, {'id': 'BG001', 'title': 'Agrylin (Elderly)', 'description': 'Anagrelide hydrochloride in ages 65 and older'}, {'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': '12', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.2', 'spread': '8.4', 'groupId': 'BG000'}, {'value': '69.2', 'spread': '3.0', 'groupId': 'BG001'}, {'value': '54.2', 'spread': '16.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Sweden', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Serbia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2008-01-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-07', 'studyFirstSubmitDate': '2006-12-19', 'resultsFirstSubmitDate': '2009-03-05', 'studyFirstSubmitQcDate': '2006-12-19', 'lastUpdatePostDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-04-08', 'studyFirstPostDateStruct': {'date': '2006-12-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Plasma Concentration (Cmax) of Agrylin', 'timeFrame': 'over 1 day'}, {'measure': 'Time of Maximum Plasma Concentration (Tmax) of Agrylin', 'timeFrame': 'over 1 day'}, {'measure': 'Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Agrylin', 'timeFrame': 'over 1 day'}, {'measure': 'Terminal Half-life (T 1/2) of Agrylin', 'timeFrame': 'over 1 day'}, {'measure': 'Total Clearance (CL/F) of Agrylin', 'timeFrame': 'over 1 day'}, {'measure': 'Volume of Distribution (Vz/F) of Agrylin', 'timeFrame': 'over 1 day'}, {'measure': 'Cmax of Active Metabolite', 'timeFrame': 'over 1 day', 'description': 'An active metabolite has therapeutic activity similar to the parent compound and must be considered in therapeutic pharmacokinetics.'}, {'measure': 'Tmax of Active Metabolite', 'timeFrame': 'over 1 day'}, {'measure': 'AUC of Active Metabolite', 'timeFrame': 'over 1 day'}, {'measure': 'T 1/2 of Active Metabolite', 'timeFrame': 'over 1 day'}, {'measure': 'CL/F of Active Metabolite', 'timeFrame': 'over 1 day'}, {'measure': 'Vz/F of Active Metabolite', 'timeFrame': 'over 1 day'}], 'secondaryOutcomes': [{'measure': 'Platelet Count', 'timeFrame': 'over 1 day', 'description': 'Platelet counts in patients with ET receiving Agrylin'}, {'measure': 'Heart Rate', 'timeFrame': 'over 1 day', 'description': 'Heart rates in patients with ET receiving Agrylin'}, {'measure': 'Systolic Blood Pressure', 'timeFrame': 'over 1 day', 'description': 'Systolic blood pressures in patients with ET receiving Agrylin'}, {'measure': 'Diastolic Blood Pressure', 'timeFrame': 'over 1 day', 'description': 'Diastolic blood pressures in patients with ET receiving Agrylin'}]}, 'conditionsModule': {'conditions': ['Essential Thrombocythaemia']}, 'referencesModule': {'references': [{'pmid': '22943924', 'type': 'DERIVED', 'citation': 'Besses C, Zeller W, Alvarez-Larran A, Coll R, Troy S, Purkayastha J, Martin P, Freitag C. Pharmacokinetics and tolerability of anagrelide hydrochloride in young (18 - 50 years) and elderly (>/= 65 years) patients with essential thrombocythemia. Int J Clin Pharmacol Ther. 2012 Nov;50(11):787-96. doi: 10.5414/CP201711.'}], 'seeAlsoLinks': [{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020333s015lbl.pdf', 'label': 'FDA-approved Label'}, {'url': 'http://www.fda.gov/opacom/7alerts.html', 'label': 'FDA Recall Information'}]}, 'descriptionModule': {'briefSummary': 'Age related differences in response to a drug could arise from variation in pharmacokinetic (PK) and/or pharmacodynamic (PD) profiles between age groups. Whilst the efficacy and safety profile of anagrelide is well established through a well-documented clinical trial programme in patients of all ages, no formal studies have been carried out to investigate whether the PK profile of anagrelide and its metabolites is altered with age.\n\nThis study is designed to allow comparisons to be made in terms of pharmacokinetics of anagrelide and its metabolites between elderly (≥ 65 years) and young (18-50 years) ET patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Young patients aged 18-50 years inclusive or Elderly patients aged 65 years and over\n* Patients must have a confirmed diagnosis of ET.\n* Currently receiving anagrelide hydrochloride at a stable maintenance dose \\< 5 mg/day for at least 4 weeks.\n\nExclusion Criteria:\n\n* Diagnosis of any other myeloproliferative disorder.\n* Current use of tobacco in any form (e.g. smoking or chewing)\n* Treatment with any known enzyme altering agents (barbiturates, phenothiazines, cimetidine etc.) within 30 days prior to or during the study.\n* Patients for whom use of another cytoreductive agent in addition to anagrelide is considered necessary for control of platelet count.'}, 'identificationModule': {'nctId': 'NCT00413634', 'briefTitle': 'The Pharmacokinetics of Anagrelide in Elderly and Young Patients With Essential Thrombocythaemia (ET)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Phase II, Open-label, Multicentre, Pharmacokinetic, Pharmacodynamic and Safety Study of Anagrelide Hydrochloride in Young (18-50 Years) and Elderly (≥ 65 Years) Patients With Essential Thrombocythaemia.', 'orgStudyIdInfo': {'id': 'SPD422-203'}, 'secondaryIdInfos': [{'id': '2004-004058-20', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Younger Participants (18-50 years)', 'interventionNames': ['Drug: anagrelide hydrochloride']}, {'type': 'EXPERIMENTAL', 'label': 'Elderly Participants (≥65 years)', 'interventionNames': ['Drug: anagrelide hydrochloride']}], 'interventions': [{'name': 'anagrelide hydrochloride', 'type': 'DRUG', 'description': 'Anagrelide hydrochloride 0.5 mg per capsule; participants will be stable on an anagrelide treatment regimen and will take capsules from their own prescription except on the PK day when the participant specific anagrelide dose will be administered from a controlled study specific supply.', 'armGroupLabels': ['Younger Participants (18-50 years)']}, {'name': 'anagrelide hydrochloride', 'type': 'DRUG', 'description': 'Anagrelide hydrochloride 0.5 mg per capsule; participants will be stable on an anagrelide regimen and will take capsules from their own prescription except on the PK day when the participant specific anagrelide dose will be administered from a controlled study specific supply.', 'armGroupLabels': ['Elderly Participants (≥65 years)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospitl Del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Luleå', 'country': 'Sweden', 'facility': 'Quintiles Hermelinen', 'geoPoint': {'lat': 65.58415, 'lon': 22.15465}}, {'zip': '75185', 'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Uppsala Akademiska Sjukhus', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}, {'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Quintiles AB Phase I Unit', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}, {'city': 'Belfast', 'country': 'United Kingdom', 'facility': 'Belfast City Hospital', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shire', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}