| tolvaptan / Generic mfg. |
2012-004071-39: Study on the effectiveness and safety of the treatment of hyponatremia due to inappropriate secretion of antidiuretic hormone (SIADH) with Tolvaptan vs fluid restriction in patients affected by pituitary disorders. STUDIO SULL’EFFICACIA E LA SICUREZZA DEL TRATTAMENTO DELL’IPONATREMIA DA INAPPROPRIATA SECREZIONE DI ORMONE ANTIDIURETICO (SIADH) CON TOLVAPTAN VS RESTRIZIONE IDRICA IN PAZIENTI AFFETTI DA LESIONI IPOFISARIE. |
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| Ongoing | 4 | 15 | Europe | Tablet, SAMSCA*10CPR 15MG | FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO, FONDAZIONE IRCCS CA'GRANDA OSPEDALE MAGGIORE POLICLINICO | Mild-moderate symptomatic hyponatremia due to syndrome of inappropriate secretion of antidiuretic hormone (SIADH) IPONATREMIA LIEVE-MODERATA SINTOMATICA SECONDARIA A SINDROME DA INAPPROPRIATA SECREZIONE DI ORMONE ANTIDIURETICO (SIADH), Mild-moderate symptomatic hyponatremia due to inappropriate secretion of antidiuretic hormone IPONATREMIA LIEVE-MODERATA SINTOMATICA SECONDARIA AD INAPPROPRIATA SECREZIONE DI ORMONE ANTIDIURETICO, Diseases [C] - Hormonal diseases [C19] | | | | |
NCT01865214: Outcome and Treatment Quality Study of Tolvaptan to Treat Hyponatremia in Patients With Heart Failure. |
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| Recruiting | 4 | 100 | RoW | Tolvaptan | Korea Otsuka International Asia Arab, Korea Otsuka Pharmaceutical Co.,Ltd. | Heart Failure With Hyponatremia | 07/14 | 12/14 | | |
ChiCTR-IPR-17011846: The safety and effectiveness of tolvaptan in primary carcinoma of liver edema patients after undergoing partial hepatectomy |
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| Not yet recruiting | 4 | 60 | | tolvaptan 15mg, once daily, for 3 days ;spironolactone 100mg, furosemide 40mg, once daily, for 3 days | Tianjin First Centre Hospital; Tianjin First Centre Hospital, Zhejiang Otsuka Pharmaceutical Co., Ltd | 术后腹水 | | | | |
ChiCTR1900023092: The study for related factors of Tolvaptan’s therapeutic effect and adverse reaction in heart failure patients based on pharmacogenomics |
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| Not yet recruiting | 4 | 150 | | tolvaptan | Ailan Chen; The First Affiliated Hospital of Guangzhou Medical University, none | heart failure | | | | |
ChiCTR2100044467: The Effectiveness and Safety of Tolvaptan on Top of Standard Medication in the Treatment of Patients With Right Heart Failure Caused by Pulmonary Hypertension |
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| Recruiting | 4 | 100 | | Tolvaputan ;Traditional diuretic | Center for Pulmonary Vascular Diseases, National Center for Cardiovascular Diseases and Fuwai Hospital, CAMS and PUMC, Beijing(100037), China; Fuwai Hospital, Beijing Medical Award Foundation | pulmonary arterial hypertension | | | | |
ChiCTR2200066643: A single center, positive control and prospective clinical study on the renal protective effect of tolvaptan versus loop diuretic in the treatment of patients with moderate and severe edema of CKD |
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| Not yet recruiting | 4 | 186 | | Tolvaptan; Tolvaptan combined with loop diuretics; loop diuretic | China-Japan Friendship Hospital; China-Japan Friendship Hospital, Jiangsu Hengrui Pharmaceutical Co., Ltd | Patients with moderate and severe edema of CKD | | | | |
ChiCTR2300075274: Precision application of tolvaptan in volume management of patients with renal disease |
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| Not yet recruiting | 4 | 240 | | Tolvaptan; Tolvaptan + tab diuretics; tab diuretics | Affiliated Zhongda Hospital of Southeast University; Zhongda Hospital, Affiliated to Southeast University, China Heart House-Chinese Cardiovascular Association HX Fund | Acute and chronic kidney disease (non-dialysis) with fluid retention | | | | |
NCT04786574: A Study to See if Tolvaptan Can Delay Dialysis in Infants and Children Who at Enrollment Are 28 Days to Less Than 12 Weeks Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD) |
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| Recruiting | 3b | 20 | Europe, US | Tolvaptan (OPC-41061) | Otsuka Pharmaceutical Development & Commercialization, Inc. | Autosomal Recessive Polycystic Kidney Disease (ARPKD) | 10/27 | 10/27 | | |
2020-005991-36: A trial to see if tolvaptan can delay dialysis in infants and children who at enrollment are 28 days to less than 12 weeks old with Autosomal Recessive Polycystic Kidney Disease (ARPKD) Die Studie untersucht, ob Tolvaptan bei Säuglingen und Kindern, die bei Studienbeginn 28 Tage bis unter 12 Wochen alt sind und an einer autosomal rezessiven polyzystischen Nierenerkrankung (ARPKD) leiden, die Dialyse verzögern kann |
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| Not yet recruiting | 3 | 20 | Europe | Tolvaptan 50mg Granules, OPC-41061, Granules for oral suspension | Otsuka Pharmaceutical Development & Commercialization, Inc., Otsuka Pharmaceutical Development & Commercialization, Inc. | Autosomal Recessive Polycystic Kidney Disease (ARPKD) Autosomal-rezessive polyzystische Nierenerkrankung (ARPKD), Genetic disorder that causes numerous cysts to grow in the kidneys. Genetische Störung, bei der zahlreiche Zysten in den Nieren wachsen., Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | | | | |
ACTRN12624000756527: Tolvaptan versus Urea in acutely hospitalised patients with low blood sodium concentration
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| Not yet recruiting | 3 | 112 | | | University of Melbourne, University of Melbourne, Otsuka Australia Pharmaceutical | Hyponatraemia | | | | |
ACTRN12619001683123p: Tolvaptan versus fluid restriction in acutely hospitalised patients with low blood sodium concentration. |
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| Not yet recruiting | 3 | 166 | | | The University of Melbourne, Otsuka Australia Pharmaceutical | Hyponatraemia | | | | |
2010-022320-67: USE OF TOLVAPTAN IN CLINICAL SYNDROMES CHARACTERIZED BY INAPPROPRIATE SECRETION OF ADH |
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| Ongoing | 3 | 45 | Europe | Tablet, TOLVAPTAN | AZIENDA OSPEDALIERA MAGGIORE DELLA CARITA, DI NOVARA | hyponatremia | | | | |
NCT03255226: Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics Study of Tolvaptan in Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload |
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| Completed | 3 | 60 | Japan | Tolvaptan | Otsuka Pharmaceutical Co., Ltd. | Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload | 07/21 | 07/21 | | |
ACTRN12619001683123: Tolvaptan versus fluid restriction in acutely hospitalised patients with low blood sodium concentration. |
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| Completed | 3 | 52 | | | The University of Melbourne, Otsuka Australia Pharmaceutical, University of Melbourne | Hyponatraemia | | | | |
NCT04782258 / 2020-005992-10: A Study to See if Tolvaptan is Safe in Infants and Children Who at Enrollment Are 28 Days to Less Than 18 Years Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD) |
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| Recruiting | 3 | 10 | Europe, US | Tolvaptan Suspension, Tolvaptan Tablets | Otsuka Pharmaceutical Development & Commercialization, Inc. | Autosomal Recessive Polycystic Kidney (ARPKD) | 02/28 | 02/28 | | |
2017-003864-10: Medication for excessive urine production in patients treated with tolvaptan Medicijnen tegen verhoogde urineproductie bij tolvaptan |
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| Ongoing | 2 | 12 | Europe | Hydrochlorothiazide, Metformin, HCT, Tablet | University Medical Center Groningen, University Medical Center Groningen | Autosomal dominant polycystic kidney disease Autosomaal dominante polycysteuze nierziekte, Polycystic kidney disease Familiaire cystenieren, Diseases [C] - Symptoms and general pathology [C23] | | | | |
SerendipityPB1, NCT05190744: PB to Treat Hereditary Nephrogenic Diabetes Insipidus, ADPKD Treated With Tolvaptan, and Severely Polyuric Patients With Previous Lithium Administration |
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| Recruiting | 2 | 20 | US | PB | Mayo Clinic, Hopital du Sacre-Coeur de Montreal | Autosomal Dominant Polycystic Kidney Disease, Nephrogenic Diabetes Insipidus, Acquired Nephrogenic Diabetes Insipidus, Congenital Nephrogenic Diabetes Insipidus | 09/25 | 12/25 | | |
ChiCTR2200058370: A multicenter cohort study of Tovastan combined with Shenfu Xiaozheng Decoction in the treatment of ADPKD patients |
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| Not yet recruiting | 1 | 40 | | Basic Western medicine treatment ;Tolvaptan ;Tolvaptan+traditional Chinese medicine ;traditional Chinese medicine | Hangzhou hospital of Traditional Chinese Medicine; Hangzhou hospital of Traditional Chinese Medicine, China Primary Health Care Foundation | ADPKD | | | | |
NCT06506994: A Study of HRS-9057 in Patients With Heart Failure and Volume Overload |
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| Not yet recruiting | 1 | 24 | RoW | HRS-9057, Tolvaptan | Fujian Shengdi Pharmaceutical Co., Ltd. | Heart Failure With Volume Overload | 09/24 | 10/24 | | |
ACTRN12624000191594: Investigating tolvaptan stimulated copeptin measurements for the differential diagnosis of polyuria-polydipsia syndrome |
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| Not yet recruiting | N/A | 40 | | | Princess Alexandra Hospital, Metro South Health Service, Metro South Research Scheme, Princess Alexandra Hospital | Polyuria polydipsia syndrome, Arginine vasopressin deficiency, Primary polydipsia | | | | |
ChiCTR1800017639: A randomized controlled trial for perioperative administration of tolvaptan in improving postoperative recovery in patients with cirrhosis |
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| Recruiting | N/A | 240 | | Tolvaptan + Furosemide ;Furosemide | Shanghai Public Health Clinical Center; Shanghai Public Health Clinical Center, self-financing | liver cirrhosis | | | | |
ChiCTR-INR-16009401: The clinical research of Shuiguitie conbined with tolvaptan treating on cirrhosis with refractory ascites |
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| Recruiting | N/A | 226 | | Shuiguitie topical plus tolvaptan 15mg po ;Shuiguitie topical placebo plus tolvaptan 15mg po | Shanghai Municipal Hospital of Traditional Chinese Medicine; Shanghai Municipal Hospital of Traditional Chinese Medicine, Clinical Research plan of SHDC | cirrhosis with refractory ascites | | | | |
ChiCTR2000028834: Effect of low-dose of tolvaptan combined with standard hydration on the incidence of contrast-induced acute kidney injury in high risk patients |
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| Recruiting | N/A | 315 | | Low dose of tolvaptan (3.75mg) and standard intravenous hydration ;High dose of tolvaptan (7.5mg) and standard intravenous hydration ;Standard intravenous hydration | Zhongda Hospital of Southeast University; Zhongda Hospital of Southeast University, Self-financing | Contast-induced Acute Kidney Injury | | | | |
ChiCTR2100044186: Single-dose, fasting and postprandial, randomized, open-ended, two-period, two-cross bioequivalence study of tolvaptan tablets in healthy subjects |
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| Recruiting | N/A | 102 | | TR ;RT ;TR ;RT ;RT | Clinical Trial Ethics Committee of the Second Affiliated Hospital of Xingtai Medical College; Brilliant Pharmacutical Co., Ltd. CHENGDU, Brilliant Pharmacutical Co.,Ltd. CHENGDU | Patients with fluid retention caused by hyponatremia and heart failure | | | | |
NCT02847624: Post-Marketing Surveillance Study of Tolvaptan in Patients With ADPKD |
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| Completed | N/A | 1672 | Japan | tolvaptan | Otsuka Pharmaceutical Co., Ltd. | Polycystic Kidney, Autosomal Dominant | 09/22 | 09/22 | | |
NCT05060523: To Study Effect of the Combination of Midodrine and Tolvaptan Versus Tolvaptan Alone in Patients With Severe Hyponatremia in Cirrhosis(TOLMINA Trial) |
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| Recruiting | N/A | 220 | RoW | Tolvaptan Tablets, Midodrine Oral Tablet, Placebo | Institute of Liver and Biliary Sciences, India | Liver Cirrhosis | 09/22 | 09/22 | | |
NCT05569655: Efficacy and Safety Evaluation of Tolvaptan in the Treatment of Patients With RHF Caused by PAH |
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| Recruiting | N/A | 100 | RoW | Tolvaptan, Samsca, Furosemide, LASâ…¨ | Chinese Pulmonary Vascular Disease Research Group | Pulmonary Arterial Hypertension, Randomized Controlled Trial | 11/22 | 12/22 | | |
ChiCTR2000035485: A single-center, randomized, double-blind, controlled trial for Low-dose dopamine combined with tolvaptan in the treatment of cardiorenal syndrome |
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| Not yet recruiting | N/A | 300 | | low-dose dopamine ;low-dose dopamine and tolvaptan; base treament | Xinhua Hospital Affliated to Shanghai Jiaotong University School of Medicine; Xinhua Hospital Affliated to Shanghai Jiaotong University School of Medicine, self-raised | Cardiorenal Syndrome | | | | |
DR-AHF, NCT04331132: Tolvaptan add-on Therapy to Overcome Loop Diuretic Resistance in Acute Heart Failure With Renal Dysfunction |
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| Recruiting | N/A | 128 | RoW | Tolvaptan 15 MG, Samsca | Gia Dinh People Hospital, Otsuka Pharmaceutical Vietnam | Acute Heart Failure | 06/23 | 07/23 | | |
ChiCTR2000035430: A Randomized Controlled Trial for FQ-16 Heart Failure Ultrafiltration Dehydration Device in the Treatment of Patients with Heart Failure Diuretic Resistance |
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| Not yet recruiting | N/A | 200 | | Therapy by ultrafiltration device FQ-16 ;addition of new diuretics to the original dose of loop diuretics V2 receptor blocker(tolvaptan) | Shanghai Chest Hospital; Shanghai Chest Hospital, Shanghai Hospital Development Center | Heart Failure | | | | |
ChiCTR2200064682: Short-term efficacy and safety of tolvaptan in the treatment of senile chronic venous insufficiency edema |
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| Not yet recruiting | N/A | 60 | | Take tolvaptan and adjust the dose ;Take placebo | Guangzhou First People's Hospital; Guangzhou First People's Hospital, General project of National Natural Science Foundation of China | Chronic venous insufficiency | | | | |
| Recruiting | N/A | 530 | Canada | | Otsuka Canada Pharmaceutical Inc. | Autosomal Dominant Polycystic Kidney Disease (ADPKD) | 12/25 | 06/26 | | |
NCT06171100: Low-dose Tolvaptan for Inpatient Hyponatraemia. |
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| Recruiting | N/A | 180 | Europe | Tolvaptan | King's College Hospital NHS Trust | Hyponatremia, SIADH | 06/24 | 12/24 | | |
ChiCTR2200060300: The cardiac and renal protective effects of tolvaptan on peritoneal dialysis patients with volume overload |
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| Not yet recruiting | N/A | 84 | | Tolvaptan, 15 mg, QOD, orally every other day (both before and after meals), for a total of 6 months of conventional treatment. ;Routine treatment for a total of 6 months. | Department of Nephrology, the second hospital of Jilin University; The second hospital of Jilin University, China Primary Health Care Foundation's | Capacity overload peritoneal dialysis patients | | | | |
| Recruiting | N/A | 2000 | Europe | | University of Cologne | ADPKD (Autosomal Dominant Polycystic Kidney Disease) | 11/25 | 12/27 | | |
| Recruiting | N/A | 600 | RoW | Tolvaptan, Samsca | Korea Otsuka Pharmaceutical Co., Ltd. | Safety | 11/25 | 11/25 | | |
ChiCTR2300072001: The efficacy of tolvaptan in the treatment of TSC2/PKD1 contiguous gene syndrome in children |
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| Recruiting | N/A | 50 | | tolvaptan | Senior department of Pediatrics, Chinese PLA General Hospital; Chinese PLA General Hospital, None | TSC2/PKD1 contiguous gene syndrome | | | | |
NCT04790175: Samsca Post-marketing General Drug Use-results Survey in Patients With Hyponatremia in SIADH |
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| Recruiting | N/A | 300 | Japan | Tolvaptan (SAMSCA) | Otsuka Pharmaceutical Co., Ltd. | Antidiuretic Hormone, Inappropriate Secretion | 08/28 | 01/30 | | |
