Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-25 @ 4:28 PM
Study NCT ID:
NCT00457457
Status:
COMPLETED
Last Update Posted:
2018-12-19
First Post:
2007-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study the Effects of Different Doses of UK-369,003 in Men With Lower Urinary Tract Symptoms.
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'}, {'id': 'C553931', 'term': '1-(6-ethoxy-5-(3-ethyl-6,7-dihydro-2-(2-methoxyethyl)-7-oxo-2H-pyrazolo(4,3-d)pyrimidin-5-yl)-3-pyridyl sulphonyl)-4-ethylpiperazine'}], '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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 609}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'dispFirstSubmitDate': '2009-03-24', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-16', 'studyFirstSubmitDate': '2007-04-05', 'dispFirstSubmitQcDate': '2010-10-27', 'studyFirstSubmitQcDate': '2007-04-05', 'dispFirstPostDateStruct': {'date': '2010-11-01', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in international prostate symptom score', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Erectile Function (EF) domain of International Index of Erectile', 'timeFrame': '12 weeks'}, {'measure': 'Function (IIEF)', 'timeFrame': '12 weeks'}, {'measure': 'Qmax', 'timeFrame': '12 weeks'}, {'measure': 'Quality of Erection questionnaire (QEQ)', 'timeFrame': '12 weeks'}, {'measure': 'Population pharmacokinetics', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['With or without erectile dysfunction'], 'conditions': ['Prostatic Hyperplasia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3711044&StudyName=Study%20the%20effects%20of%20different%20doses%20of%20UK-369%2C003%20in%20men%20with%20lower%20urinary%20tract%20symptoms.%20%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This is a 12 week study in which different doses and formulations of UK-369,003 will be administered to patients with a diagnosis of enlarged prostate. Patients will complete a series of questionnaires before, during and after treatment to assess if UK-369,003 has improved their urinary symptoms and erectile function . There will be several blood samples taken during the study to asses the level of drug in the blood and correlate it with the responses to the questionnaires.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male subjects aged 40 years and above, with documented LUTS with an International Prostate Symptom Score (IPSS) ≥13\n2. Clinical diagnosis of BPH.\n3. Qmax 5 to 15ml/sec with a voided volume of ≥150ml at visit 1 (screening).\n\nExclusion Criteria:\n\n1. Urinary tract infection\n2. Primary neurological conditions affecting bladder function'}, 'identificationModule': {'nctId': 'NCT00457457', 'briefTitle': 'Study the Effects of Different Doses of UK-369,003 in Men With Lower Urinary Tract Symptoms.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Multi-center, Randomized, Parallel Group, Double-blind, Placebo Controlled Proof of Concept and Dose Ranging Study With an Active Control to Assess the Efficacy and Safety/Tolerability of UK-369,003 Immediate Release (IR) and Modified Release (MR) in the Treatment of Men With Lower Urinary Tract Symptoms (LUTS) With and Without Erectile Dysfunction (ED)', 'orgStudyIdInfo': {'id': 'A3711044'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Comparator', 'description': 'Tamsulosin 0.4 mg prolonged release', 'interventionNames': ['Drug: Tamsulosin']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Arm', 'description': 'There are 5 possible UK-369,003 arms as follows: UK-369,003 MR (10mg, 25mg, 50mg \\& 100mg), UK-369,003 IR (40mg),', 'interventionNames': ['Drug: UK-369,003']}], 'interventions': [{'name': 'Tamsulosin', 'type': 'DRUG', 'description': 'Tamsulosin hydrochloride capsules, 0.4 mg. Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate', 'armGroupLabels': ['Comparator']}, {'name': 'UK-369,003', 'type': 'DRUG', 'description': 'UK 369,003 is a highly selective and potent inhibitor of PDE5. It has increased selectivity for PDE5 over PDE6 (\\>80 fold) compared to sildenafil (\\~10 fold). Two recently completed trials have shown efficacy for UK-369,003 in treating subjects with ED', 'armGroupLabels': ['Treatment Arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Herston', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': 'B-1090', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': 'B-2650', 'city': 'Edegem', 'country': 'Belgium', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': 'T2V 4R6', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'N6A 4V2', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'H9R 4S3', 'city': 'Pointe-Claire', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 45.44868, 'lon': -73.81669}}, {'zip': '4810371', 'city': 'Temuco', 'state': 'Región de la Araucanía', 'country': 'Chile', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -38.73628, 'lon': -72.59738}}, {'city': 'Santiago', 'country': 'Chile', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '0', 'city': 'Medellín', 'state': 'Antioquia', 'country': 'Colombia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}, {'zip': '0', 'city': 'Barranquilla', 'state': 'Atlántico', 'country': 'Colombia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 10.96854, 'lon': -74.78132}}, {'zip': '0', 'city': 'Bogota', 'state': 'Cundinamarca', 'country': 'Colombia', 'facility': 'Pfizer Investigational Site'}, {'city': 'Bogota', 'state': 'Cundinamarca', 'country': 'Colombia', 'facility': 'Pfizer Investigational Site'}, {'zip': '0', 'city': 'Cali', 'state': 'Valle del Cauca Department', 'country': 'Colombia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 3.43054, 'lon': -76.5199}}, {'zip': '9100', 'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'zip': '8200', 'city': 'Aarhus N', 'country': 'Denmark', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 56.20367, 'lon': 10.17317}}, {'zip': '2820', 'city': 'Gentofte Municipality', 'country': 'Denmark', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 55.74903, 'lon': 12.54601}}, {'zip': '00100', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '70100', 'city': 'Kuopio', 'country': 'Finland', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}, {'zip': '90100', 'city': 'Oulu', 'country': 'Finland', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}, {'zip': '33100', 'city': 'Tampere', 'country': 'Finland', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'zip': '41110', 'city': 'Larissa', 'country': 'Greece', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.62847, 'lon': 22.42112}}, {'zip': '26500', 'city': 'Rio', 'country': 'Greece', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 38.29558, 'lon': 21.78504}}, {'zip': '56403', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '71100', 'city': 'Foggia', 'country': 'Italy', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.45845, 'lon': 15.55188}}, {'zip': '53100', 'city': 'Siena', 'country': 'Italy', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.31822, 'lon': 11.33064}}, {'zip': 'LV-1002', 'city': 'Riga', 'country': 'Latvia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'zip': '47144', 'city': 'Kaunas', 'country': 'Lithuania', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}, {'zip': '50009', 'city': 'Kaunas', 'country': 'Lithuania', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}, {'zip': '08661', 'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'zip': '85-092', 'city': 'Bydgoszcz', 'country': 'Poland', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '85-168', 'city': 'Bydgoszcz', 'country': 'Poland', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '80-402', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '81-393', 'city': 'Gdynia', 'country': 'Poland', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 54.51889, 'lon': 18.53188}}, {'zip': '41-400', 'city': 'Mysłowice', 'country': 'Poland', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.20745, 'lon': 19.16668}}, {'zip': '84-200', 'city': 'Wejherowo', 'country': 'Poland', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 54.60568, 'lon': 18.23559}}, {'zip': '851 01', 'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'zip': '901 01', 'city': 'Malacky', 'country': 'Slovakia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 48.43604, 'lon': 17.02188}}, {'zip': '949 01', 'city': 'Nitra', 'country': 'Slovakia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 48.30763, 'lon': 18.08453}}, {'zip': '080 01', 'city': 'Prešov', 'country': 'Slovakia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 48.99923, 'lon': 21.2355}}, {'zip': '909 82', 'city': 'Skalica', 'country': 'Slovakia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 48.8449, 'lon': 17.22635}}, {'zip': '28035', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '29010', 'city': 'Málaga', 'country': 'Spain', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '46010', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': 'BS2 8HW', 'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer Inc'}}}}