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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-173512 | Other Identifier | Japic |
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The objective of this study is to investigate the efficacy and safety of tolvaptan based on the change in serum sodium concentration following administration of tolvaptan oral tablets at 7.5 to 60 mg/day for up to 30 days in patients with hyponatremia in the SIADH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tolvaptan | Experimental | Tolvaptan tablets at 7.5, 15, 30 (one tablet each), or 60 mg (two 30 mg tablets) will be orally administered once daily after breakfast for up to 30 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tolvaptan Oral Tablet | Drug | Tolvaptan tablets at 7.5, 15, 30 (one tablet each), or 60 mg (two 30 mg tablets) will be orally administered once daily after breakfast for up to 30 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Normalized Serum Sodium Concentration on the Day After Final IMP Administration | The percentage of subjects with normalized serum sodium concentration, defined as ≥135 mEq/L, on the day after final IMP administration will be calculated versus the number of subjects with serum sodium concentration of <135 mEq/L at baseline on Day 1 of the treatment period. | Baseline, Day2, Day3, Day4, Day5, Day7, Day14, Day21, Day after final study medication |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum Sodium Concentration | The mean and standard error of measured values for serum sodium concentration on the day of fixing the maintenance dose and on the day after final IMP administration were calculated. The day of fixing the maintenance dose: Day2, Day3, Day4, Day5, Day7, Day14, and Day21 | Day2, Day3, Day4, Day5, Day7, Day14, Day21 and the day after final IMP administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chubu Region | Japan | |||||
Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.
Supporting Materials: Study Protocol and Statistical Analysis Plan (SAP) Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data.
Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.
Data will be available aftermarketing approval in global markets, or beginning1-3 years following article Publication. There is no end date to the availability of the data.
Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and Ranalytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.
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Adults with a definite diagnosis of SIADH in reference to "Diagnostic and Treatment Manual of the Hypersecretion of Vasopressin (SIADH), Revised in 2011"
This trial was conducted in 16 participants from 31 trial sites in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tolvaptan | Tolvaptan tablets at 7.5, 15, 30 (one tablet each), or 60 mg (two 30 mg tablets) will be orally administered once daily after breakfast for up to 30 days. Tolvaptan Oral Tablet: Tolvaptan tablets at 7.5, 15, 30 (one tablet each), or 60 mg (two 30 mg tablets) will be orally administered once daily after breakfast for up to 30 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 19, 2019 | Jul 15, 2020 |
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| Chugoku Region |
| Japan |
| Kanto Region | Japan |
| Kinki Region | Japan |
| Kyushu Region | Japan |
| Sikoku Region | Japan |
| COMPLETED |
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| NOT COMPLETED |
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Safety analysis set, which included in patients who received ≥1 dose of the study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tolvaptan | Tolvaptan tablets at 7.5, 15, 30 (one tablet each), or 60 mg (two 30 mg tablets) will be orally administered once daily after breakfast for up to 30 days. Tolvaptan Oral Tablet: Tolvaptan tablets at 7.5, 15, 30 (one tablet each), or 60 mg (two 30 mg tablets) will be orally administered once daily after breakfast for up to 30 days. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects With Normalized Serum Sodium Concentration on the Day After Final IMP Administration | The percentage of subjects with normalized serum sodium concentration, defined as ≥135 mEq/L, on the day after final IMP administration will be calculated versus the number of subjects with serum sodium concentration of <135 mEq/L at baseline on Day 1 of the treatment period. | Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation. | Posted | Number | percentage of participants | Baseline, Day2, Day3, Day4, Day5, Day7, Day14, Day21, Day after final study medication |
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| Secondary | Change in Serum Sodium Concentration | The mean and standard error of measured values for serum sodium concentration on the day of fixing the maintenance dose and on the day after final IMP administration were calculated. The day of fixing the maintenance dose: Day2, Day3, Day4, Day5, Day7, Day14, and Day21 | Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation. | Posted | Mean | Standard Error | mEq/L | Day2, Day3, Day4, Day5, Day7, Day14, Day21 and the day after final IMP administration |
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Adverse events were monitored from signing of the informed consent form until follow-up, up to 7 weeks on average.
A serious adverse event (SAE) was an untoward medical occurrence that resulted in death or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or a new problem experienced by a participant when enrolled in a trial whether or not it was considered drug related by study physician.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tolvaptan | Tolvaptan | 1 | 16 | 5 | 16 | 15 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Supraventricular extrasystoles | Cardiac disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Ventricular extrasystoles | Cardiac disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Bacteraemia | Infections and infestations | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Loss of consciousness | Nervous system disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Paralysis of recurrent laryngeal nerve | Nervous system disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Circulatory collapse | Vascular disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Haemorrhage | Vascular disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Supraventricular extrasystoles | Cardiac disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Ventricular extrasystoles | Cardiac disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Cerumen impaction | Ear and labyrinth disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Cataract | Eye disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Anorectal disorder | Gastrointestinal disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Dental caries | Gastrointestinal disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Malaise | General disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Thirst | General disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Bacteaemia | Infections and infestations | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Gingivitis | Infections and infestations | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Periodontitis | Infections and infestations | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Skin bacterial Infection | Infections and infestations | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Wound | Injury, poisoning and procedural complications | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Blood alanine phoshatase increased | Investigations | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Blood sodium increased | Investigations | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Nuetrophil count decreased | Investigations | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Weight decreased | Investigations | MedDRA Ver.21.1 | Non-systematic Assessment |
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| White blood cell count increased | Investigations | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| hypocalcaemia | Metabolism and nutrition disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Loss of consciousness | Nervous system disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Paralysis recurrent Laryngeal nerve | Nervous system disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Depressive symptom | Psychiatric disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Bladder disoder | Renal and urinary disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Rapid correction of hyponatremia | Surgical and medical procedures | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Circulatory collapse | Vascular disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Haemorrhage | Vascular disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Orthostatic hypotension | Vascular disorders | MedDRA Ver.21.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Otsuka Pharmaceutical Co., LTD. | +81-3-6361-7366 | CL_OPCJ_RDA_Team@otsuka.jp |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | May 15, 2018 | Jul 15, 2020 | Prot_001.pdf |
| ID | Term |
|---|---|
| D007177 | Inappropriate ADH Syndrome |
| ID | Term |
|---|---|
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077602 | Tolvaptan |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Day5 |
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| Day7 |
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| Day14 |
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| Day21 |
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| Day after final study medication |
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