Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-25 @ 9:01 PM
Study NCT ID:
NCT01262456
Status:
COMPLETED
Last Update Posted:
2015-10-15
First Post:
2010-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Investigation of the Superiority Effect of Orally Disintegrating Desmopressin Tablets to Placebo in Terms of Night Voids Reduction in Nocturia Adult Male Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053158', 'term': 'Nocturia'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003894', 'term': 'Deamino Arginine Vasopressin'}], 'ancestors': [{'id': 'D001127', 'term': 'Arginine Vasopressin'}, {'id': 'D014667', 'term': 'Vasopressins'}, {'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'DK0-Disclosure@ferring.com', 'title': 'Clinical Development Support', 'organization': 'Ferring Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 through Month 3 for double-blind period; Month 4 for open-label period', 'eventGroups': [{'id': 'EG000', 'title': 'Desmopressin 50 μg Double-Blind', 'description': 'Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.', 'otherNumAtRisk': 119, 'otherNumAffected': 6, 'seriousNumAtRisk': 119, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Desmopressin 75 μg Double-Blind', 'description': 'Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.', 'otherNumAtRisk': 122, 'otherNumAffected': 7, 'seriousNumAtRisk': 122, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'Placebo Double-Blind', 'description': 'Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.', 'otherNumAtRisk': 143, 'otherNumAffected': 5, 'seriousNumAtRisk': 143, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Desmopressin 50 μg Double-Blind / 100 μg Open-Label', 'description': 'Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.', 'otherNumAtRisk': 101, 'otherNumAffected': 0, 'seriousNumAtRisk': 101, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Desmopressin 75 μg Double-Blind / 100 μg Open-Label', 'description': 'Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.', 'otherNumAtRisk': 102, 'otherNumAffected': 0, 'seriousNumAtRisk': 102, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Placebo Double-Blind / Desmopressin 100 μg Open-Label', 'description': 'Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.', 'otherNumAtRisk': 124, 'otherNumAffected': 1, 'seriousNumAtRisk': 124, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Transient global amnesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Mean Number of Nocturnal Voids Averaged Over a 3-Month Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '142', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Desmopressin 75 μg Double-Blind', 'description': 'Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.'}, {'id': 'OG001', 'title': 'Desmopressin 50 μg Double-Blind', 'description': 'Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.'}, {'id': 'OG002', 'title': 'Placebo Double-Blind', 'description': 'Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.'}], 'classes': [{'title': 'Week 1 (n=120, 116, 141)', 'categories': [{'measurements': [{'value': '-1.06', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '-0.973', 'spread': '0.898', 'groupId': 'OG001'}, {'value': '-0.591', 'spread': '1.05', 'groupId': 'OG002'}]}]}, {'title': 'Month 1 (n=117, 112, 139)', 'categories': [{'measurements': [{'value': '-1.4', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '-1.31', 'spread': '1.01', 'groupId': 'OG001'}, {'value': '-0.928', 'spread': '1.96', 'groupId': 'OG002'}]}]}, {'title': 'Month 2 (n=113, 107, 132)', 'categories': [{'measurements': [{'value': '-1.43', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '1.04', 'groupId': 'OG001'}, {'value': '-1.01', 'spread': '1.14', 'groupId': 'OG002'}]}]}, {'title': 'Month 3 (n=106, 103, 125)', 'categories': [{'measurements': [{'value': '-1.37', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '-1.25', 'spread': '1.01', 'groupId': 'OG001'}, {'value': '-0.984', 'spread': '1.04', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.41', 'ciLowerLimit': '-0.61', 'ciUpperLimit': '-0.22', 'pValueComment': 'A priori threshold for significance was p\\<=0.05.', 'groupDescription': 'Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary outcomes in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level.\n\nA summary of mean change in nocturnal voids, assessed longitudinally during 3 months of treatment, is presented below for the FAS using LOCF.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Repeated measures ANCOVA of change from baseline at Week 1, Months 1, 2, 3, adjusted for age (\\<65, ≥65 years), visit, and baseline nocturnal voids.', 'testedNonInferiority': False}, {'pValue': '0.0003', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.37', 'ciLowerLimit': '-0.57', 'ciUpperLimit': '-0.17', 'pValueComment': 'A priori threshold for significance was p\\<=0.05', 'groupDescription': 'Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary outcomes in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level.\n\nA summary of mean change in nocturnal voids, assessed longitudinally during 3 months of treatment, is presented below for the FAS using LOCF.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Repeated measures ANCOVA of change from baseline at Week 1, Months 1, 2, 3, adjusted for age (\\<65, ≥65 years), visit, and baseline nocturnal voids.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (Baseline), Week 1, Months 1, 2, 3 (3-month double-blind treatment period)', 'description': 'The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during-treatment visits (Week 1, Months 1, 2, 3) as recorded in participant diaries. The first morning void was not counted as a nocturnal void. Change from baseline values for Week 1, and Months 1, 2 and 3 are reported below.\n\nComparison of the mean number of nocturnal voids at baseline and over a 3-month treatment period (obtained by longitudinal analysis of Week 1, and Months 1, 2 and 3) are reported in the statistical analysis. This was the first co-primary outcome. Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary outcomes in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level.', 'unitOfMeasure': 'nocturnal voids', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS).'}, {'type': 'PRIMARY', 'title': 'Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids for All During-Treatment Visits up to Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '142', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Desmopressin 75 μg Double-Blind', 'description': 'Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.'}, {'id': 'OG001', 'title': 'Desmopressin 50 μg Double-Blind', 'description': 'Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.'}, {'id': 'OG002', 'title': 'Placebo Double-Blind', 'description': 'Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.67', 'groupId': 'OG000'}, {'value': '0.67', 'groupId': 'OG001'}, {'value': '0.50', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0004', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.04', 'ciLowerLimit': '1.38', 'ciUpperLimit': '3.03', 'pValueComment': 'A priori threshold for significance was p\\<=0.05.', 'groupDescription': 'Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary endpoints in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level.', 'statisticalMethod': 'Generalized Estimating Equation (GEE)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'GEE Method for 33% responder status at Week 1, Month 1, Month 2, and Month 3, adjusted for age (\\<65, ≥65 years), visit, and baseline nocturnal voids.', 'testedNonInferiority': False}, {'pValue': '0.0009', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.98', 'ciLowerLimit': '1.32', 'ciUpperLimit': '2.96', 'pValueComment': 'A priori threshold for significance was p\\<=0.05.', 'groupDescription': 'Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary endpoints in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level.', 'statisticalMethod': 'Generalized Estimating Equation (GEE)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'GEE Method for 33% responder status at Week 1, Month 1, Month 2, and Month 3, adjusted for age (\\<65, ≥65 years), visit, and baseline nocturnal voids.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (Baseline), Week 1, Months 1, 2, 3 (3-month double-blind treatment period)', 'description': 'Probability of participants achieving 33% responder status during 3 months of treatment employed a longitudinal analysis assessing nocturnal void information captured in the 3-day diary. A 33% responder was defined as a participant with a decrease of at least 33% in the mean number of nocturnal voids relative to baseline. The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during treatment visits (Week 1, Months 1, 2, 3) as recorded in participant diaries. The first morning void was not counted as a nocturnal void.\n\nThis was the second co-primary outcome. Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary endpoints in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level.', 'unitOfMeasure': 'probability', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Number of Nocturnal Voids at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Desmopressin 75 μg Double-Blind', 'description': 'Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.'}, {'id': 'OG001', 'title': 'Desmopressin 50 μg Double-Blind', 'description': 'Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.'}, {'id': 'OG002', 'title': 'Placebo Double-Blind', 'description': 'Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.37', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '-1.25', 'spread': '1.01', 'groupId': 'OG001'}, {'value': '-0.984', 'spread': '1.04', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0029', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.35', 'ciLowerLimit': '-0.57', 'ciUpperLimit': '-0.12', 'pValueComment': 'A priori threshold for significance was p\\<=0.05.', 'groupDescription': 'Change from baseline in the adjusted mean number of nocturnal voids in the FAS using LOCF.\n\nThe active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA of change from baseline adjusted for age (\\<65, \\>=65) and baseline nocturnal voids using last observation carried forward.', 'testedNonInferiority': False}, {'pValue': '0.0128', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.29', 'ciLowerLimit': '-0.52', 'ciUpperLimit': '-0.06', 'pValueComment': 'A priori threshold for significance was p\\<=0.05.', 'groupDescription': 'Change from baseline in the adjusted mean number of nocturnal voids in the FAS using LOCF.\n\nThe active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA of change from baseline adjusted for age (\\<65, \\>=65) and baseline nocturnal voids.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (Baseline), Month 3', 'description': 'Comparison of the mean number of nocturnal voids at baseline and at the 3-month visit. The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to the relevant visits as recorded in participant diaries. The first morning void was not counted as a nocturnal void.\n\nThe secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).', 'unitOfMeasure': 'nocturnal voids', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS), including participants with complete data supporting this outcome in the participant diary.'}, {'type': 'SECONDARY', 'title': 'Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Desmopressin 75 μg Double-Blind', 'description': 'Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.'}, {'id': 'OG001', 'title': 'Desmopressin 50 μg Double-Blind', 'description': 'Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.'}, {'id': 'OG002', 'title': 'Placebo Double-Blind', 'description': 'Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.68', 'groupId': 'OG000'}, {'value': '0.66', 'groupId': 'OG001'}, {'value': '0.54', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0233', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.81', 'ciLowerLimit': '1.08', 'ciUpperLimit': '3.02', 'pValueComment': 'A priori threshold for significance was p\\<=0.05.', 'groupDescription': 'The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistical regression of 33% responder status adjusted for age (\\<65, \\>=65) and baseline nocturnal voids using last observation carried forward.', 'testedNonInferiority': False}, {'pValue': '0.0386', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.72', 'ciLowerLimit': '1.03', 'ciUpperLimit': '2.87', 'pValueComment': 'A priori threshold for significance was p\\<=0.05.', 'groupDescription': 'The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistical regression of 33% responder status adjusted for age (\\<65, \\>=65) and baseline nocturnal voids using last observation carried forward.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (Baseline), Month 3', 'description': 'Probability of participants achieving 33% responder status at Month 3 employed a longitudinal analysis assessing nocturnal void information captured in the 3-day diary. A 33% responder was defined as a participant with a decrease of at least 33% in the mean number of nocturnal voids relative to baseline. The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the Month 3 visit as recorded in participant diaries. The first morning void was not counted as a nocturnal void.\n\nThe secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).', 'unitOfMeasure': 'probability', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS, including participants with complete data supporting this outcome in the participant diary.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Time to First Nocturnal Void at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Desmopressin 75 μg Double-Blind', 'description': 'Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.'}, {'id': 'OG001', 'title': 'Desmopressin 50 μg Double-Blind', 'description': 'Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.'}, {'id': 'OG002', 'title': 'Placebo Double-Blind', 'description': 'Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '117', 'spread': '130', 'groupId': 'OG000'}, {'value': '113', 'spread': '119', 'groupId': 'OG001'}, {'value': '71.5', 'spread': '108', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0026', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '42.76', 'ciLowerLimit': '15.02', 'ciUpperLimit': '70.51', 'pValueComment': 'A priori threshold for significance was p\\<=0.05.', 'groupDescription': 'The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA of change from baseline adjusted for age (\\<65, \\>=65) and baseline time to first nocturnal void using last observation carried forward.', 'testedNonInferiority': False}, {'pValue': '0.0064', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '38.95', 'ciLowerLimit': '11.03', 'ciUpperLimit': '66.88', 'pValueComment': 'A priori threshold for significance was p\\<=0.05.', 'groupDescription': 'The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA of change from baseline adjusted for age (\\<65, \\>=65) and baseline time to first nocturnal void using last observation carried forward.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (Baseline), Month 3', 'description': 'The time to first void was defined as the time from going to bed with the intention of sleeping until first nocturnal void or until waking in the morning in the case where there was no nocturnal void. The first morning void was not counted as a nocturnal void. The time to first void was derived from the sleep and voiding diary. The mean time to first void was calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit.\n\nThe secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS, including participants with complete data supporting this outcome in the participant diary.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Nocturnal Urine Volume at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Desmopressin 75 μg Double-Blind', 'description': 'Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.'}, {'id': 'OG001', 'title': 'Desmopressin 50 μg Double-Blind', 'description': 'Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.'}, {'id': 'OG002', 'title': 'Placebo Double-Blind', 'description': 'Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-199', 'spread': '274', 'groupId': 'OG000'}, {'value': '-186', 'spread': '263', 'groupId': 'OG001'}, {'value': '-144', 'spread': '260', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0034', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-86.17', 'ciLowerLimit': '-143.69', 'ciUpperLimit': '-28.64', 'pValueComment': 'A priori threshold for significance was p\\<=0.05.', 'groupDescription': 'The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA of change from baseline adjusted for age (\\<65, \\>=65) and baseline nocturnal urine volume using last observation carried forward.', 'testedNonInferiority': False}, {'pValue': '0.0086', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-77.80', 'ciLowerLimit': '-135.70', 'ciUpperLimit': '-19.89', 'pValueComment': 'A priori threshold for significance was p\\<=0.05.', 'groupDescription': 'The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA of change from baseline adjusted for age (\\<65, \\>=65) and baseline nocturnal urine volume using last observation carried forward.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (Baseline), Month 3', 'description': 'The nocturnal urine volume was derived from the 3-day urine volume diary. The nocturnal urine volume included the volume of the first morning void. Mean urine volumes were calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit.\n\nThe secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS, including participants with complete data supporting this outcome in the participant diary.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 24-Hour Urine Volume at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Desmopressin 75 μg Double-Blind', 'description': 'Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.'}, {'id': 'OG001', 'title': 'Desmopressin 50 μg Double-Blind', 'description': 'Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.'}, {'id': 'OG002', 'title': 'Placebo Double-Blind', 'description': 'Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-224', 'spread': '549', 'groupId': 'OG000'}, {'value': '-194', 'spread': '491', 'groupId': 'OG001'}, {'value': '-197', 'spread': '442', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.4126', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-45.31', 'ciLowerLimit': '-153.94', 'ciUpperLimit': '63.32', 'pValueComment': 'A priori threshold for significance was p\\<=0.05.', 'groupDescription': 'The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA of change from baseline adjusted for age (\\<65, \\>=65) and baseline 24-hour urine volume using last observation carried forward.', 'testedNonInferiority': False}, {'pValue': '0.7353', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-18.79', 'ciLowerLimit': '-127.99', 'ciUpperLimit': '90.41', 'pValueComment': 'A priori threshold for significance was p\\<=0.05.', 'groupDescription': 'The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA of change from baseline adjusted for age (\\<65, \\>=65) and baseline 24-hour urine volume using last observation carried forward.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (Baseline), Month 3', 'description': 'Twenty-four hour urine volume was derived from the 3-day urine volume diary. Mean urine volumes were calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit.\n\nThe secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS, including participants with complete data supporting this outcome in the participant diary.'}, {'type': 'SECONDARY', 'title': 'Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Double-Blind', 'description': 'Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.'}, {'id': 'OG001', 'title': 'Desmopressin 50 μg Double-Blind', 'description': 'Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.'}, {'id': 'OG002', 'title': 'Desmopressin 75 μg Double-Blind', 'description': 'Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.'}], 'classes': [{'title': 'All AEs', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}]}, {'title': 'Severe AEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Adverse drug reactions (ADRs)', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}, {'title': 'AEs leading to discontinuation', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'ADRs leading to discontinuation', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Serious AEs (SAEs)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 through Month 3 (double-blind period)', 'description': 'A TEAE was any adverse event (AE) occurring after start of treatment and within the time of residual drug effect, i.e., within 1 day for desmopressin. An adverse drug reaction (ADR) was any AE assessed by the investigator as possibly or probably related to study drug.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set (SAS)'}, {'type': 'SECONDARY', 'title': 'Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Open-Label Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Double-Blind / Desmopressin 100 μg Open-Label', 'description': 'Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.'}, {'id': 'OG001', 'title': 'Desmopressin 50 μg Double-Blind / 100 μg Open-Label', 'description': 'Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.'}, {'id': 'OG002', 'title': 'Desmopressin 75 μg Double-Blind / 100 μg Open-Label', 'description': 'Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.'}], 'classes': [{'title': 'All AEs', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}]}, {'title': 'Severe AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Adverse drug reactions (ADRs)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'AEs leading to discontinuation', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'ADRs leading to discontinuation', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Serious AEs (SAEs)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 1 of open-label period (Month 4 of treatment)', 'description': 'A TEAE was any adverse event (AE) occurring after start of treatment and within the time of residual drug effect, i.e., within 1 day for desmopressin. An adverse drug reaction (ADR) was any AE assessed by the investigator as possibly or probably related to study drug.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set (SAS) for open label-treatment period'}, {'type': 'SECONDARY', 'title': 'Minimum Post-Treatment Serum Sodium Levels in the Double-Blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Double-Blind', 'description': 'Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.'}, {'id': 'OG001', 'title': 'Desmopressin 50 μg Double-Blind', 'description': 'Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.'}, {'id': 'OG002', 'title': 'Desmopressin 75 μg Double-Blind', 'description': 'Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.'}], 'classes': [{'title': '≤125 mmol/L', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': '126-129 mmol/L', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': '130-134 mmol/L', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': '≥135 mmol/L', 'categories': [{'measurements': [{'value': '141', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 through Month 3 (double-blind period)', 'description': 'Serum sodium levels were monitored at each study visit since hyponatremia is a potential serious adverse event associated with daily doses of desmopressin. The serum sodium level must have been within the normal reference range at the Screening Visit for the participant to be eligible for enrollment. A participant was to be withdrawn from the trial if the serum sodium level was \\<=125 mmol/L at any time.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set (SAS)'}, {'type': 'SECONDARY', 'title': 'Minimum Post-Treatment Serum Sodium Levels in the Open-Label Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Double-Blind / Desmopressin 100 μg Open-Label', 'description': 'Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.'}, {'id': 'OG001', 'title': 'Desmopressin 50 μg Double-Blind / 100 μg Open-Label', 'description': 'Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.'}, {'id': 'OG002', 'title': 'Desmopressin 75 μg Double-Blind / 100 μg Open-Label', 'description': 'Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.'}], 'classes': [{'title': '≤125 mmol/L', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': '126-129 mmol/L', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': '130-134 mmol/L', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': '≥135 mmol/L', 'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 1 of open-label period (Month 4 of treatment)', 'description': 'Serum sodium levels were monitored at each study visit since hyponatremia is a potential serious adverse event associated with daily doses of desmopressin. The serum sodium level must have been within the normal reference range at the Screening Visit for the participant to be eligible for enrollment. A participant was to be withdrawn from the trial if the serum sodium level was \\<=125 mmol/L at any time.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set (SAS) during open-label treatment period'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo Double-Blind / Desmopressin 100 μg Open-Label', 'description': 'Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for the 1-month open-label extension period.'}, {'id': 'FG001', 'title': '50 μg Double-Blind / 100 μg Open-Label', 'description': 'Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for the 1-month open-label extension period.'}, {'id': 'FG002', 'title': 'Desmopressin 75 μg Double-Blind / 100 μg Open-Label', 'description': 'Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for the 1-month open-label extension period.'}], 'periods': [{'title': '3-Month Double-Blind Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Intent-to-Treat (ITT) population: randomized participants regardless of exposure to treatment', 'groupId': 'FG000', 'numSubjects': '143'}, {'comment': 'ITT population: randomized participants regardless of exposure to treatment', 'groupId': 'FG001', 'numSubjects': '123'}, {'comment': 'ITT population: randomized participants regardless of exposure to treatment', 'groupId': 'FG002', 'numSubjects': '129'}]}, {'type': 'Full Analysis Set (FAS)', 'achievements': [{'comment': 'FAS: ITT with at least 1 post-treatment efficacy assessment. Analysis as randomized.', 'groupId': 'FG000', 'numSubjects': '142'}, {'comment': 'FAS: ITT with at least 1 post-treatment efficacy assessment. Analysis as randomized.', 'groupId': 'FG001', 'numSubjects': '119'}, {'comment': 'FAS: ITT with at least 1 post-treatment efficacy assessment. Analysis as randomized.', 'groupId': 'FG002', 'numSubjects': '124'}]}, {'type': 'Safety Analysis Set (SAS)', 'achievements': [{'comment': 'SAS: received at least 1 dose and had at least 1 safety assessment. Analysis on actual treatment.', 'groupId': 'FG000', 'numSubjects': '143'}, {'comment': 'SAS: received at least 1 dose and had at least 1 safety assessment. Analysis on actual treatment.', 'groupId': 'FG001', 'numSubjects': '119'}, {'comment': 'SAS: received at least 1 dose and had at least 1 safety assessment. Analysis on actual treatment.', 'groupId': 'FG002', 'numSubjects': '122'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '124'}, {'groupId': 'FG001', 'numSubjects': '100'}, {'groupId': 'FG002', 'numSubjects': '103'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '26'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}]}]}, {'title': '1-Month Open-Label Extension Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '124'}, {'groupId': 'FG001', 'numSubjects': '100'}, {'groupId': 'FG002', 'numSubjects': '103'}]}, {'type': 'Safety Analysis Set (SAS)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '124'}, {'groupId': 'FG001', 'numSubjects': '101'}, {'comment': '1 subject was randomized to Desmopressin 75 μg but received 50 μg. Also true in Double-Blind Period', 'groupId': 'FG002', 'numSubjects': '102'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '120'}, {'groupId': 'FG001', 'numSubjects': '97'}, {'groupId': 'FG002', 'numSubjects': '98'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Other Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of 1013 participants were screened; 618 were screening failures and 395 were randomized. The most common reason for screening failure was non-fulfillment of inclusion/exclusion criteria (535 participants); 23 participants withdrew consent prior to randomization and 60 participants had other reasons for screening failure.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}, {'value': '385', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo Double-Blind', 'description': 'Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.'}, {'id': 'BG001', 'title': 'Desmopressin 50 μg Double-Blind', 'description': 'Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.'}, {'id': 'BG002', 'title': 'Desmopressin 75 μg Double-Blind', 'description': 'Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.8', 'spread': '14.2', 'groupId': 'BG000'}, {'value': '60.8', 'spread': '13.2', 'groupId': 'BG001'}, {'value': '60.1', 'spread': '11.6', 'groupId': 'BG002'}, {'value': '60.6', 'spread': '13.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '200', 'groupId': 'BG003'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '185', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}, {'value': '385', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}, {'value': '310', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}, {'value': '311', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '29.2', 'spread': '5.25', 'groupId': 'BG000'}, {'value': '29.3', 'spread': '4.77', 'groupId': 'BG001'}, {'value': '29.2', 'spread': '4.79', 'groupId': 'BG002'}, {'value': '29.2', 'spread': '4.95', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Demographic data offered from the Full Analysis Set population.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 395}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'dispFirstSubmitDate': '2012-04-26', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-16', 'studyFirstSubmitDate': '2010-12-15', 'dispFirstSubmitQcDate': '2012-04-26', 'resultsFirstSubmitDate': '2015-06-18', 'studyFirstSubmitQcDate': '2010-12-16', 'dispFirstPostDateStruct': {'date': '2012-04-27', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-10-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-09-16', 'studyFirstPostDateStruct': {'date': '2010-12-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Mean Number of Nocturnal Voids Averaged Over a 3-Month Period', 'timeFrame': 'Day 1 (Baseline), Week 1, Months 1, 2, 3 (3-month double-blind treatment period)', 'description': 'The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during-treatment visits (Week 1, Months 1, 2, 3) as recorded in participant diaries. The first morning void was not counted as a nocturnal void. Change from baseline values for Week 1, and Months 1, 2 and 3 are reported below.\n\nComparison of the mean number of nocturnal voids at baseline and over a 3-month treatment period (obtained by longitudinal analysis of Week 1, and Months 1, 2 and 3) are reported in the statistical analysis. This was the first co-primary outcome. Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary outcomes in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level.'}, {'measure': 'Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids for All During-Treatment Visits up to Month 3', 'timeFrame': 'Day 1 (Baseline), Week 1, Months 1, 2, 3 (3-month double-blind treatment period)', 'description': 'Probability of participants achieving 33% responder status during 3 months of treatment employed a longitudinal analysis assessing nocturnal void information captured in the 3-day diary. A 33% responder was defined as a participant with a decrease of at least 33% in the mean number of nocturnal voids relative to baseline. The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during treatment visits (Week 1, Months 1, 2, 3) as recorded in participant diaries. The first morning void was not counted as a nocturnal void.\n\nThis was the second co-primary outcome. Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary endpoints in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Mean Number of Nocturnal Voids at Month 3', 'timeFrame': 'Day 1 (Baseline), Month 3', 'description': 'Comparison of the mean number of nocturnal voids at baseline and at the 3-month visit. The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to the relevant visits as recorded in participant diaries. The first morning void was not counted as a nocturnal void.\n\nThe secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).'}, {'measure': 'Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids at Month 3', 'timeFrame': 'Day 1 (Baseline), Month 3', 'description': 'Probability of participants achieving 33% responder status at Month 3 employed a longitudinal analysis assessing nocturnal void information captured in the 3-day diary. A 33% responder was defined as a participant with a decrease of at least 33% in the mean number of nocturnal voids relative to baseline. The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the Month 3 visit as recorded in participant diaries. The first morning void was not counted as a nocturnal void.\n\nThe secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).'}, {'measure': 'Change From Baseline in Mean Time to First Nocturnal Void at Month 3', 'timeFrame': 'Day 1 (Baseline), Month 3', 'description': 'The time to first void was defined as the time from going to bed with the intention of sleeping until first nocturnal void or until waking in the morning in the case where there was no nocturnal void. The first morning void was not counted as a nocturnal void. The time to first void was derived from the sleep and voiding diary. The mean time to first void was calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit.\n\nThe secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).'}, {'measure': 'Change From Baseline in Nocturnal Urine Volume at Month 3', 'timeFrame': 'Day 1 (Baseline), Month 3', 'description': 'The nocturnal urine volume was derived from the 3-day urine volume diary. The nocturnal urine volume included the volume of the first morning void. Mean urine volumes were calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit.\n\nThe secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).'}, {'measure': 'Change From Baseline in 24-Hour Urine Volume at Month 3', 'timeFrame': 'Day 1 (Baseline), Month 3', 'description': 'Twenty-four hour urine volume was derived from the 3-day urine volume diary. Mean urine volumes were calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit.\n\nThe secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).'}, {'measure': 'Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Period', 'timeFrame': 'From Day 1 through Month 3 (double-blind period)', 'description': 'A TEAE was any adverse event (AE) occurring after start of treatment and within the time of residual drug effect, i.e., within 1 day for desmopressin. An adverse drug reaction (ADR) was any AE assessed by the investigator as possibly or probably related to study drug.'}, {'measure': 'Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Open-Label Period', 'timeFrame': 'Month 1 of open-label period (Month 4 of treatment)', 'description': 'A TEAE was any adverse event (AE) occurring after start of treatment and within the time of residual drug effect, i.e., within 1 day for desmopressin. An adverse drug reaction (ADR) was any AE assessed by the investigator as possibly or probably related to study drug.'}, {'measure': 'Minimum Post-Treatment Serum Sodium Levels in the Double-Blind Period', 'timeFrame': 'Day 1 through Month 3 (double-blind period)', 'description': 'Serum sodium levels were monitored at each study visit since hyponatremia is a potential serious adverse event associated with daily doses of desmopressin. The serum sodium level must have been within the normal reference range at the Screening Visit for the participant to be eligible for enrollment. A participant was to be withdrawn from the trial if the serum sodium level was \\<=125 mmol/L at any time.'}, {'measure': 'Minimum Post-Treatment Serum Sodium Levels in the Open-Label Period', 'timeFrame': 'Month 1 of open-label period (Month 4 of treatment)', 'description': 'Serum sodium levels were monitored at each study visit since hyponatremia is a potential serious adverse event associated with daily doses of desmopressin. The serum sodium level must have been within the normal reference range at the Screening Visit for the participant to be eligible for enrollment. A participant was to be withdrawn from the trial if the serum sodium level was \\<=125 mmol/L at any time.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Nocturia']}, 'referencesModule': {'references': [{'pmid': '23454402', 'type': 'RESULT', 'citation': 'Weiss JP, Herschorn S, Albei CD, van der Meulen EA. Efficacy and safety of low dose desmopressin orally disintegrating tablet in men with nocturia: results of a multicenter, randomized, double-blind, placebo controlled, parallel group study. J Urol. 2013 Sep;190(3):965-72. doi: 10.1016/j.juro.2012.12.112. Epub 2013 Feb 20.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial was to confirm/establish long-term safety and efficacy of desmopressin orally disintegrating tablets at dose levels of 50 μg and 75 μg and to further evaluate the safety of an efficacious higher dose level of 100 μg in males with nocturia.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent prior to performance of any trial-related activity\n* Male sex 18 years of age or older\n* At least 2 voids every night in a consecutive 3-day period during the screening period based on the patient diary.\n\nExclusion Criteria:\n\n* Evidence of severe daytime voiding dysfunction defined as: Urge urinary incontinence (more than 1 episode/day in the 3-day diary period), Urgency (more than 1 episode/day in the 3-day diary period), Frequency (more than 8 daytime voids/day in the 3-day diary period)\n* Interstitial Cystitis\n* Chronic prostatitis/chronic pelvic pain syndrome\n* Suspicion of bladder outlet obstruction (BOO) or a urine flow of less than 5 mL/s as confirmed by uroflowmetry performed after suspicion of BOO\n* Surgical treatment, including transurethral resection, for BOO or benign prostatic hyperplasia within the past 6 months\n* Urinary retention or a post void residual volume in excess of 250 mL as confirmed by bladder ultrasound performed after suspicion of urinary retention\n* Habitual or psychogenic fluid intake resulting in a urine production exceeding 40 mL/kg/24 hours\n* Central or nephrogenic diabetes insipidus.\n* Syndrome of inappropriate anti-diuretic hormone.\n* Current or a history of urologic malignancies e.g. urothelium, prostate, or kidney cancer\n* Genitourinary tract pathology e.g. infection or stone in the bladder and urethra causing symptoms\n* Neurogenic detrusor activity (detrusor overactivity)\n* Suspicion or evidence of cardiac failure\n* Uncontrolled hypertension\n* Uncontrolled diabetes mellitus\n* Hyponatraemia: Serum sodium level must be within normal limits\n* Renal insufficiency: Serum creatinine must be within normal limits and estimated glomerular filtration rate must be more than or equal to 50 mL/min\n* Hepatic and/or biliary diseases: Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels must not be more than twice the upper limit of normal range. Total bilirubin level must not be more than 1.5 mg/dL\n* History of obstructive sleep apnea\n* Previous desmopressin treatment for nocturia\n* Treatment with another investigational product within 3 months prior to screening\n* Concomitant treatment with any prohibited medication, i.e. loop diuretics (furosemide, torsemide, ethacrynic acid) and any other investigational drug\n* Known alcohol or substance abuse\n* Work or lifestyle that may interfere with regular nighttime sleep e.g. shift workers\n* Any other medical condition, laboratory abnormality, psychiatric condition, mental incapacity, or language barrier that, in the judgment of the investigator, would impair participation in the trial'}, 'identificationModule': {'nctId': 'NCT01262456', 'briefTitle': 'Investigation of the Superiority Effect of Orally Disintegrating Desmopressin Tablets to Placebo in Terms of Night Voids Reduction in Nocturia Adult Male Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferring Pharmaceuticals'}, 'officialTitle': 'A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel-group Trial With an Open-label Extension to Demonstrate the Efficacy and Safety of Desmopressin Orally Disintegrating Tablets for the Treatment of Nocturia in Adult Males', 'orgStudyIdInfo': {'id': 'FE992026 CS41'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Desmopressin 50 μg Double-Blind / 100 μg Open-Label', 'description': 'Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants completing the double-blind period were switched to desmopressin 100 μg for the 1-month open-label extension period.', 'interventionNames': ['Drug: Desmopressin']}, {'type': 'EXPERIMENTAL', 'label': 'Desmopressin 75 μg Double-Blind / 100 μg Open-Label', 'description': 'Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants completing the double-blind period were switched to desmopressin 100 μg for the 1-month open-label extension period.', 'interventionNames': ['Drug: Desmopressin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Double-Blind / Desmopressin 100 μg Open-Label', 'description': 'Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants completing the double-blind period were switched to desmopressin 100 μg for the 1-month open-label extension period.', 'interventionNames': ['Drug: Desmopressin', 'Drug: Placebo']}], 'interventions': [{'name': 'Desmopressin', 'type': 'DRUG', 'otherNames': ['FE992026', 'MINIRIN®', 'Nocturin®'], 'armGroupLabels': ['Desmopressin 50 μg Double-Blind / 100 μg Open-Label', 'Desmopressin 75 μg Double-Blind / 100 μg Open-Label', 'Placebo Double-Blind / Desmopressin 100 μg Open-Label']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo Double-Blind / Desmopressin 100 μg Open-Label']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pinnacle Research Group, LLC', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Medical Affiliated Research Center, Inc.', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Radiant Research, Inc.', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Premiere Pharmaceutical Research', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'city': 'Foothill Rance', 'state': 'California', 'country': 'United States', 'facility': 'Family Medical Center'}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Axis Clinical Trials', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Santa Rosa', 'state': 'California', 'country': 'United States', 'facility': 'Radiant Research, Inc.', 'geoPoint': {'lat': 38.44047, 'lon': -122.71443}}, {'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Genitourinary Surgical Consultants', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'Denver', 'state': 'Colorado', 'country': 'United 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