Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2026-02-22 @ 4:52 PM
Study NCT ID:
NCT02038868
Status:
COMPLETED
Last Update Posted:
2024-11-06
First Post:
2014-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy and Safety of ASP4901 in Patients With Benign Prostate Hyperplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}], 'ancestors': [{'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077409', 'term': 'Tamsulosin'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 320}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2014-04-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-05', 'studyFirstSubmitDate': '2014-01-15', 'studyFirstSubmitQcDate': '2014-01-15', 'lastUpdatePostDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in total IPSS (International Prostate Symptom Score)', 'timeFrame': 'baseline and at the final evaluation (up to 5 weeks)'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in each symptom score of IPSS', 'timeFrame': 'baseline and at the final evaluation (up to 5 weeks)'}, {'measure': 'Change from baseline in IPSS QOL (quality of life) score', 'timeFrame': 'baseline and at the final evaluation (up to 5 weeks)'}, {'measure': 'Proportion of IPSS responder', 'timeFrame': 'baseline and at the final evaluation (up to 5 weeks)', 'description': '"IPSS responder" is defined as 25% improvement in IPSS'}, {'measure': 'Plasma concentration of ASP4901', 'timeFrame': 'up to 5 weeks', 'description': 'only for ASP4901 group'}, {'measure': 'Safety assessed by the incidence of adverse events, vital signs, labo-tests and 12-lead ECGs', 'timeFrame': 'up to 5 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ASP4901', 'BPH'], 'conditions': ['Benign Prostate Hyperplasia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://astellasclinicalstudyresults.com/study.aspx?ID=291', 'label': 'Link to results on the Astellas Clinical Study Results website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy of ASP4901 with placebo in patients with benign prostatic hyperplasia. The safety and tolerability of ASP4901 will also be evaluated.', 'detailedDescription': 'This is a multicenter, randomized, parallel-group, placebo-controlled, active-referenced, double-blind study. After obtaining the written consent, patients meeting the eligibility criteria at the preliminary enrollment will receive oral administration of placebo in a single-blinded manner (single-blind placebo run-in period). Then, patients meeting the eligibility criteria at the main enrollment will receive drug or placebo (double-blind treatment period) for 4 weeks. Furthermore, patients will be followed up for 1 week to confirm the safety of the study drugs after the treatment period (safety follow-up period).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* dysuria associated with BPH for at least 12 weeks before providing consent\n* a total IPSS core of 13 or higher\n* a QOL score of 3 or higher\n* a maximum urinary flow rate (Qmax) of ≥4 mL/sec and \\<15 mL/sec.\n* a prostate volume of ≥20 mL.\n\nExclusion Criteria:\n\n* A postvoid residual volume (PVR) of \\>350 mL\n* A previous or concurrent symptomatic urinary tract infection within 4 weeks of the study\n* A cataract operation scheduled to be performed during the study period\n* Previous or concurrent clinically relevant cardiovascular or cerebrovascular disorder within 24 weeks prior to the study\n* Hypersensitivity to ASP4901 or tamsulosin hydrochloride\n* Presence of serious hepatic diseases, renal diseases, immunological diseases, or pulmonary diseases that are clinically relevant'}, 'identificationModule': {'nctId': 'NCT02038868', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of ASP4901 in Patients With Benign Prostate Hyperplasia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'Double-Blind, Placebo-Controlled, Active-Referenced, Parallel-Group Comparative Study in Patients With Benign Prostatic Hyperplasia', 'orgStudyIdInfo': {'id': '4901-CL-0201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ASP4901 group', 'description': 'After the main enrollment, patients will receive an oral dose of ASP4901 once daily for 4 weeks (double-blind treatment period).', 'interventionNames': ['Drug: ASP4901']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'After the main enrollment, patients will receive an oral dose of placebo once daily for 4 weeks (double-blind treatment period).', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tamsulosin group', 'description': 'After the main enrollment, patients will receive an oral dose of tamsulosin once daily for 4 weeks (double-blind treatment period).', 'interventionNames': ['Drug: Tamsulosin']}], 'interventions': [{'name': 'ASP4901', 'type': 'DRUG', 'description': 'oral', 'armGroupLabels': ['ASP4901 group']}, {'name': 'Tamsulosin', 'type': 'DRUG', 'otherNames': ['YM617', 'Harnal'], 'description': 'oral', 'armGroupLabels': ['Tamsulosin group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'oral', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kansai', 'country': 'Japan'}, {'city': 'Kanto', 'country': 'Japan'}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma Inc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}