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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-090948 | Other Identifier | JAPIC |
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ADPKD patients who were enrolled in Study 156-05-002 will receive repeated oral administration of OPC-41061 at doses of 15 mg twice daily (morning and evening). Administration will be continued until the time of manufacturing and distribution approval of OPC-41061 for ADPKD in Japan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPC-41061 | Experimental | Repeated oral administration at doses of 15 mg twice daily (morning and evening) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPC-41061 | Drug | Repeated oral administration at doses of 15 mg twice daily (morning and evening) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Kidney Volume | Individual subject data on the volumes of the total kidney volume (sum of the volumes of the left and right kidneys) measured by magnetic resonance imaging or computed tomography during trial period. Repeated oral administration at doses of 15 mg twice daily (morning and evening) until approval of the revised protocol (Edition 4.0) by the IRB of each trial site. Number of participants analyzed at each time point represents number of participants with data at the specified time point. Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.) are excluded. | Baseline, Week 48, 96, 144, and 192 |
| Renal Function Test (eGFR) | Individual subject data on eGFR (estimated glomerular filtration rate calculated by Japanese eGFR equation) during trial period. Number of participants analyzed at each time point represents number of participants with data at the specified time point. Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.) are excluded. | Baseline, Week 48, 96, 144, and 192 |
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Inclusion Criteria:
Exclusion Criteria:
Patients with eGFR of less than 15 mL/min/1.73 m2
Patients with any of the following complications:
Patients with any of the following complications or history thereof:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kanto Region | Japan |
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| ID | Title | Description |
|---|---|---|
| FG000 | OPC-41061 | Repeated oral administration at doses of 15 mg twice daily (morning and evening) until approval of the revised protocol (Edition 4.0) by the IRB of each trial site. Repeated oral administration at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg twice daily (morning and evening) following approval of the revised protocol. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OPC-41061 | Repeated oral administration at doses of 15 mg twice daily (morning and evening) until approval of the revised protocol (Edition 4.0) by the IRB of each trial site. Repeated oral administration at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg twice daily (morning and evening) following approval of the revised protocol. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Total Kidney Volume | Individual subject data on the volumes of the total kidney volume (sum of the volumes of the left and right kidneys) measured by magnetic resonance imaging or computed tomography during trial period. Repeated oral administration at doses of 15 mg twice daily (morning and evening) until approval of the revised protocol (Edition 4.0) by the IRB of each trial site. Number of participants analyzed at each time point represents number of participants with data at the specified time point. Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.) are excluded. | Posted | Median | Inter-Quartile Range | mL | Baseline, Week 48, 96, 144, and 192 |
|
|
| ||||||||||||||||||||||||||||||||||||||
| Primary | Renal Function Test (eGFR) | Individual subject data on eGFR (estimated glomerular filtration rate calculated by Japanese eGFR equation) during trial period. Number of participants analyzed at each time point represents number of participants with data at the specified time point. Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.) are excluded. | Posted | Median | Inter-Quartile Range | mL/min/1.73 m2 | Baseline, Week 48, 96, 144, and 192 |
|
Through study completion, an average of 4 years
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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 | OPC-41061 | Repeated oral administration at doses of 15 mg twice daily (morning and evening) until approval of the revised protocol (Edition 4.0) by the IRB of each trial site. Repeated oral administration at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg twice daily (morning and evening) following approval of the revised protocol. | 0 | 13 | 6 | 13 | 13 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinal vein occlusion | Eye disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Hepatic cyst infection | Infections and infestations | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Alcoholism | Psychiatric disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Nephrogenic anaemia | Blood and lymphatic system disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Supraventricular extrasystoles | Cardiac disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Angle closure glaucoma | Eye disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Asthenopia | Eye disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Meibomianitis | Eye disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Retinal vein occlusion | Eye disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Eyelids pruritus | Eye disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Hyperchlorhydria | Gastrointestinal disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Thirst | General disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Biliary cirrhosis primary | Hepatobiliary disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Acute tonsillitis | Infections and infestations | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Pertussis | Infections and infestations | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Hepatic cyst infection | Infections and infestations | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Enterocolitis viral | Infections and infestations | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Blood antidiuretic hormone increased | Investigations | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Blood osmolarity increased | Investigations | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Electrocardiogram T wave inversion | Investigations | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Haematocrit increased | Investigations | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Haemoglobin increased | Investigations | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Red blood cell count increased | Investigations | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Cystatin C increased | Investigations | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Urinary casts present | Investigations | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Exostosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Joint contracture | Musculoskeletal and connective tissue disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Hyperaesthesia | Nervous system disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Alcoholism | Psychiatric disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Eating disorder | Psychiatric disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Polyuria | Renal and urinary disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Renal cyst haemorrhage | Renal and urinary disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Endometriosis | Reproductive system and breast disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Menopausal symptoms | Reproductive system and breast disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
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| Metrorrhagia | Reproductive system and breast disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Tonsillar inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Chloasma | Skin and subcutaneous tissue disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Urticaria cholinergic | Skin and subcutaneous tissue disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA/JVersion 17.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Otsuka Pharmaceutical Co.,Ltd. | +81-3-6361-7366 |
| ID | Term |
|---|---|
| D016891 | Polycystic Kidney, Autosomal Dominant |
| ID | Term |
|---|---|
| D007690 | Polycystic Kidney Diseases |
| D052177 | Kidney Diseases, Cystic |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000072661 | Ciliopathies |
| D030342 | Genetic Diseases, Inborn |
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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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Repeated oral administration at doses of 15 mg twice daily (morning and evening) until approval of the revised protocol (Edition 4.0) by the IRB of each trial site.
Repeated oral administration at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg twice daily (morning and evening) following approval of the revised protocol.
| OG003 | Week 144 | Repeated oral administration at doses of 15 mg twice daily (morning and evening) until approval of the revised protocol (Edition 4.0) by the IRB of each trial site. Repeated oral administration at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg twice daily (morning and evening) following approval of the revised protocol. |
| OG004 | Week 192 | Repeated oral administration at doses of 15 mg twice daily (morning and evening) until approval of the revised protocol (Edition 4.0) by the IRB of each trial site. Repeated oral administration at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg twice daily (morning and evening) following approval of the revised protocol. |
|
|