Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-02-26 @ 3:17 AM
Study NCT ID:
NCT02637960
Status:
COMPLETED
Last Update Posted:
2018-10-31
First Post:
2015-12-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of Fedovapagon for Nocturia in Men With Benign Prostatic Hyperplasia (BPH)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053158', 'term': 'Nocturia'}, {'id': 'D011470', 'term': 'Prostatic Hyperplasia'}], 'ancestors': [{'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 432}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'dispFirstSubmitDate': '2018-10-29', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-29', 'studyFirstSubmitDate': '2015-12-17', 'dispFirstSubmitQcDate': '2018-10-29', 'studyFirstSubmitQcDate': '2015-12-17', 'dispFirstPostDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the mean number of night-time voids', 'timeFrame': '12 weeks'}, {'measure': 'Change in mean patient reported nocturia bother score', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in the mean number of night-time voids', 'timeFrame': '1 week'}, {'measure': 'Change in the mean number of night-time voids', 'timeFrame': '4 weeks'}, {'measure': 'Change in mean patient reported nocturia bother score', 'timeFrame': '1 week'}, {'measure': 'Change in mean patient reported nocturia bother score', 'timeFrame': '4 weeks'}, {'measure': 'Change in mean night-time urine production, absolute and as a proportion of 24 hour urine production', 'timeFrame': '2 months'}, {'measure': 'Change in mean functional bladder capacity', 'timeFrame': '2 months'}, {'measure': 'Change in International Prostate Symptom Score (IPSS)', 'timeFrame': '4 weeks'}, {'measure': 'Change in International Prostate Symptom Score (IPSS)', 'timeFrame': '12 weeks'}, {'measure': 'Change in N-QOL Score', 'timeFrame': '4 weeks'}, {'measure': 'Change in N-QOL Score', 'timeFrame': '12 weeks'}, {'measure': 'Number and type of Adverse Events', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['VA106483, fedovapagon, BPH, nocturia, EQUINOC'], 'conditions': ['Nocturia']}, 'descriptionModule': {'briefSummary': 'This study will investigate the efficacy and safety of fedovapagon in the treatment of nocturia in men with BPH.', 'detailedDescription': 'Fedovapagon is a selective vasopressin V2 receptor (V2R) agonist that has an antidiuretic effect through stimulation of V2 receptors in the kidney and is being developed for the treatment of nocturia. Nocturia, defined as the complaint that the individual has to wake at night one or more times to void, is a common condition and shows an age-dependent increase in both prevalence and severity (number of nocturnal voids). It has a significant detrimental impact on the quality of life in patients with benign prostatic hyperplasia (BPH).\n\nThe purpose of this study is to determine the efficacy and safety of fedovapagon in the treatment of nocturia with BPH.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult males ≥18 years \\[no upper limit\\]\n* Benign prostatic hyperplasia\n* Persistent nocturia despite previous lifestyle modification advice including appropriate fluid management\n* Serum sodium not below lower limit of normal prior to randomization\n* Provide signed and dated informed consent before any study-specific procedures are conducted.\n* Able to comply with the requirements of the study.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02637960', 'acronym': 'EQUINOC', 'briefTitle': 'Efficacy Study of Fedovapagon for Nocturia in Men With Benign Prostatic Hyperplasia (BPH)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vantia Ltd'}, 'officialTitle': 'A Randomised, Double-blind, Placebo-controlled, Multi-centre Study to Investigate the Efficacy and Safety of Fedovapagon in the Treatment of Nocturia in Men With Benign Prostatic Hyperplasia (BPH) (EQUINOC Study)', 'orgStudyIdInfo': {'id': '483-013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fedovapagon 2 mg', 'description': 'One daily dose of 2 mg fedovapagon for 12 weeks', 'interventionNames': ['Drug: Fedovapagon 2 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo matched to fedovapagon', 'description': 'One daily dose of placebo (matched to fedovapagon) for 12 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Fedovapagon 2 mg', 'type': 'DRUG', 'description': 'One daily dose of 2 mg fedovapagon for 12 weeks', 'armGroupLabels': ['Fedovapagon 2 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'One daily dose of placebo (matched to fedovapagon) for 12 weeks', 'armGroupLabels': ['Placebo matched to fedovapagon']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'facility': 'Vantia Investigative Center', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'city': 'Goodyear', 'state': 'Arizona', 'country': 'United States', 'facility': 'Vantia Investigative Center', 'geoPoint': {'lat': 33.43532, 'lon': -112.35821}}, {'city': 'Lincoln', 'state': 'California', 'country': 'United States', 'facility': 'Vantia Investigative Center', 'geoPoint': {'lat': 38.89156, 'lon': -121.29301}}, {'city': 'Murrieta', 'state': 'California', 'country': 'United States', 'facility': 'Vantia Investigative Center', 'geoPoint': {'lat': 33.55391, 'lon': -117.21392}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Vantia Investigative Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 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