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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-090690 |
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Investigation into the long-term safety and efficacy of OPC-41061 in repeated oral administrations at doses of 15 mg twice daily in patients with ADPKD who completed the preceding dose-finding study (156-04-001).
Investigation into the long-term safety and efficacy of OPC-41061 in repeated oral administrations at doses of 15 mg twice daily in patients with ADPKD who completed the preceding dose-finding study (156-04-001).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPC-41061 | Drug | orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years. |
|
| 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. 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 Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.)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 24, 52, 104, and 156 |
| 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 Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.)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 24, 48, 104, and 156 |
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Inclusion Criteria:
Exclusion Criteria:
Patients with serum creatinine concentration of 2.5 mg/dL or higher at the screening examination
Patients with any of the following complications
Patients with any of the following complications or history thereof
Patients with SBP (in sitting position) <90 mm Hg (at screening examination)
Patients with history of massive bleeding or bleeding tendency
Patients with a history of drug or alcohol abuse within 6 months prior to the screening examination
Pregnant women, lactating women, or women who may become or plan to become pregnant
Patients who received any investigational drug other than OPC-41061 within 30 days prior to commencement of administration of OPC-41061
Any patient who, in the opinion of the principle investigator or attending investigators, should not participate in the study
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kanto Region | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39356039 | Derived | St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3. | |
| 21903984 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | OPC-41061 | Orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Higashihara E, Torres VE, Chapman AB, Grantham JJ, Bae K, Watnick TJ, Horie S, Nutahara K, Ouyang J, Krasa HB, Czerwiec FS; TEMPOFormula and 156-05-002 Study Investigators. Tolvaptan in autosomal dominant polycystic kidney disease: three years' experience. Clin J Am Soc Nephrol. 2011 Oct;6(10):2499-507. doi: 10.2215/CJN.03530411. Epub 2011 Sep 8. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | OPC-41061 | Orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years. |
| 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. 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 24, 52, 104, and 156 |
|
|
| ||||||||||||||||||||||||||||||||||||||
| 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/1.73m2 | Baseline, Week 24, 48, 104, and 156 |
|
3 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 | Orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years. | 1 | 17 | 2 | 17 | 17 | 17 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diverticulitis | Infections and infestations | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Asthenopia | Eye disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Gastric polyps | Gastrointestinal disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Periodontal disease | Gastrointestinal disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Periodontitis | Gastrointestinal disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Gastrointestinal telangiectasia | Gastrointestinal disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Mass | General disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Thirst | General disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Inflammation | General disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Vessel puncture site haematoma | General disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Acute tonsillitis | Infections and infestations | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Urethritis | Infections and infestations | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Muscle injury | Injury, poisoning and procedural complications | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Tooth injury | Injury, poisoning and procedural complications | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Mouth injury | Injury, poisoning and procedural complications | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Blood antidiuretic hormone increased | Investigations | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Blood calcium increased | Investigations | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA/JVersion 13.0 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Blood osmolarity decreased | Investigations | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Blood osmolarity increased | Investigations | MedDRA/JVersion 13.0 | Systematic Assessment |
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| Blood triglycerides increased | Investigations | MedDRA/JVersion 13.0 | Systematic Assessment |
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| Blood uric acid increased | Investigations | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Monocyte count increased | Investigations | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Red blood cell count decreased | Investigations | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Blood phosphorus increased | Investigations | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase decreased | Investigations | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Urine output increased | Investigations | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Glossopharyngeal neuralgia | Nervous system disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Hyperaesthesia | Nervous system disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Intracranial aneurysm | Nervous system disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Arachnoid cyst | Nervous system disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Adjustment disorder with depressed mood | Psychiatric disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Polyuria | Renal and urinary disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Breast cyst | Reproductive system and breast disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Dyshidrosis | Skin and subcutaneous tissue disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA/JVersion 13.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA/JVersion 13.0 | 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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| OG003 | Week 104 | Orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years. 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. |
| OG004 | Week 156 | Orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years. 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. |
|
|