Samsca    (DrugBank: -)

2 diseases
IDDisease name (Link within this page)Number of trials
67Polycystic kidney disease8
72Pituitary ADH secretion disorder6

67. Polycystic kidney disease    [ 186 clinical trials,   196 drugs,   (DrugBank: 47 drugs),   35 drug target genes,   146 drug target pathways]
Searched query = "Polycystic kidney disease", "PKD", "PCKD", "Polycystic kidney", "ADPKD", "ARPKD"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
8 / 186 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03406286
(ClinicalTrials.gov)
July 19, 201622/12/2017Samsca PMS in ADPKD PatientsPost-Marketing Surveillance(PMS) of Safety and Efficacy of Samsca® Tablets in Korean Patients With ADPKDSafetyDrug: TolvaptanKorea Otsuka Pharmaceutical Co., Ltd.NULLRecruiting18 YearsN/AAll600Korea, Republic of
2EUCTR2015-001903-30-DK
(EUCTR)
26/06/201513/05/2015Effect of tolvaptan on renal blood flow and glomerular filtration in patients with polycystic kidney diseaseEffect of tolvaptan on RBF and GFR in ADPKD - Tolvaptan and RPF in ADPKD Adult dominant polycystic kidney disease (ADPKD)
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Physical Phenomena [G01]
Trade Name: Samsca
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN
Department of Medical ResearchNULLNot RecruitingFemale: yes
Male: yes
30Phase 2Denmark
3EUCTR2014-001973-15-DK
(EUCTR)
18/11/201427/06/2014The effcts of tolvaptan on renal handling of water and salt, hormones in the blood at the circulation, during blocking of the nitric oxide (NO) system in patients with autosomal dominant polycystic kidney diseaseRenal Handling of Water and Sodium in Autosomal Dominant Polycystic Kidney Disease.The effects of tolvaptan on renal handling of water and sodium , vasoactive hormones and central hemodynamics during baseline conditions and after inhibition of the nitric oxide system in patients with autosomal dominant polycystic kidney disease - TOPO HyponatreamiaSIADH ( Syndrome of Inappropriate Antidiuretic Hormone Secretion) OverhydrationAutosomal dominant polycystic kidney disease
MedDRA version: 17.0;Level: LLT;Classification code 10021038;Term: Hyponatremia;System Organ Class: 100000004861
MedDRA version: 17.0;Classification code 10040626;Term: SIADH;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Physiological processes [G07]
Trade Name: Samsca
Product Name: Tolvaptan
Product Code: C03XA01
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN
University Clinic in Nephrology and Hypertension, Department of Medical ResearchNULLNot RecruitingFemale: yes
Male: yes
Denmark
4EUCTR2010-018401-10-NL
(EUCTR)
14/01/201121/10/2010A global clinical research study using a drug that is used in patients for the treatment of multiple cysts which form on the kidneys.A Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 17.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Samsca
Product Name: Tolvaptan
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
INN or Proposed INN: Tolvaptan
Otsuka Pharmaceutical Development & Commercialization, IncNULLNot RecruitingFemale: yes
Male: yes
1500France;United States;Canada;Poland;Belgium;Romania;Russian Federation;Afghanistan;Germany;Netherlands;Italy;United Kingdom
5EUCTR2010-018401-10-BE
(EUCTR)
23/11/201003/09/2010A global clinical research study using a drug that is used in patients for the treatment of multiple cysts which form on the kidneys.A Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 17.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Samsca 15 mg tablets
Product Name: Tolvaptan 15 mg tablets
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Trade Name: Samsca 30 mg tablets
Product Name: Tolvaptan 30 mg tablets
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Otsuka Pharmaceutical Development & Commercialization, IncNULLNot RecruitingFemale: yes
Male: yes
1500Phase 3France;United States;Canada;Argentina;Poland;Belgium;Romania;Russian Federation;Netherlands;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2010-018401-10-FR
(EUCTR)
15/11/201027/07/2010A Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD)A Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 12.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant
Trade Name: Samsca 15 mg tablets
Product Name: Tolvaptan 15 mg tablets
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Trade Name: Samsca 30 mg tablets
Product Name: Tolvaptan 30 mg tablets
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Otsuka Pharmaceutical Development & Commercialization, IncNULLNot RecruitingFemale: yes
Male: yes
1500Phase 3France;Belgium;Netherlands;Germany;Italy;United Kingdom
7EUCTR2010-019025-33-NL
(EUCTR)
31/08/201027/07/2010A Phase IIa, Single-Center Study, Investigating the Short-Term Renal Hemodynamic Effects, Safety and Pharmacokinetics/Pharmacodynamics of Oral Tolvaptan (OPC-41061) in Subjects with Autosomal Dominant Polycystic Kidney Disease at Various Stages of Renal FunctionA Phase IIa, Single-Center Study, Investigating the Short-Term Renal Hemodynamic Effects, Safety and Pharmacokinetics/Pharmacodynamics of Oral Tolvaptan (OPC-41061) in Subjects with Autosomal Dominant Polycystic Kidney Disease at Various Stages of Renal Function Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 12.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant
Trade Name: Samsca 15 mg tablets
Product Name: Tolvaptan 15 mg tablets
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Trade Name: Samsca 30 mg tablets
Product Name: Tolvaptan 30 mg tablets
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Otsuka Pharmaceutical Development Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes
36Phase 2aNetherlands
8EUCTR2010-018401-10-DE
(EUCTR)
07/07/201010/06/2010A global clinical research study using a drug that is used in patients for the treatment of multiple cysts which form on the kidneys.A Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 17.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Samsca 15 mg tablets
Product Name: Tolvaptan 15 mg tablets
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Trade Name: Samsca 30 mg tablets
Product Name: Tolvaptan 30 mg tablets
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Otsuka Pharmaceutical Development & Commercialization, IncNULLNot RecruitingFemale: yes
Male: yes
1500France;United States;Canada;Argentina;Poland;Belgium;Romania;Russian Federation;Netherlands;Germany;Italy;United Kingdom

72. Pituitary ADH secretion disorder    [ 36 clinical trials,   22 drugs,   (DrugBank: 5 drugs),   2 drug target genes,   4 drug target pathways]
Searched query = "Pituitary ADH secretion disorder", "Inappropriate antidiuretic hormone secretion", "Syndrome of inappropriate secretion of antidiuretic hormone", "Inappropriate ADH syndrome", "Syndrome of inappropriate ADH", "Central diabetes insipidus", "Syndrome of inappropriate secretion of ADH", "SIADH"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
6 / 36 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2014-001973-15-DK
(EUCTR)
18/11/201427/06/2014The effcts of tolvaptan on renal handling of water and salt, hormones in the blood at the circulation, during blocking of the nitric oxide (NO) system in patients with autosomal dominant polycystic kidney diseaseRenal Handling of Water and Sodium in Autosomal Dominant Polycystic Kidney Disease.The effects of tolvaptan on renal handling of water and sodium , vasoactive hormones and central hemodynamics during baseline conditions and after inhibition of the nitric oxide system in patients with autosomal dominant polycystic kidney disease - TOPO HyponatreamiaSIADH ( Syndrome of Inappropriate Antidiuretic Hormone Secretion) OverhydrationAutosomal dominant polycystic kidney disease
MedDRA version: 17.0;Level: LLT;Classification code 10021038;Term: Hyponatremia;System Organ Class: 100000004861
MedDRA version: 17.0;Classification code 10040626;Term: SIADH;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Physiological processes [G07]
Trade Name: Samsca
Product Name: Tolvaptan
Product Code: C03XA01
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN
University Clinic in Nephrology and Hypertension, Department of Medical ResearchNULLNot RecruitingFemale: yes
Male: yes
Denmark
2EUCTR2013-003800-38-DK
(EUCTR)
24/02/201409/12/2013The effects of tolvaptan on renal handeling of water and salt, hormones in the blood and the circulation, during blocking of the nitric oxide (NO) system in healthy subjects. A dose-response study.The effects of tolvaptan on renal handling of water and sodium, vasoactive hormones and circulatory system, during basal conditions and during inhibition of the nitric oxide system in healthy subjects. A dose-response study. - DOVA HyponatremiaSIADH (Syndrome of Inappropriate Antidiuretic Hormone secretion)
MedDRA version: 14.1;Level: LLT;Classification code 10021038;Term: Hyponatremia;System Organ Class: 100000004861
MedDRA version: 14.1;Classification code 10040626;Term: SIADH;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Physiological processes [G07]
Trade Name: Samsca
Product Name: Tolvaptan
Product Code: C03XA01
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN
Department of Medical ResearchNULLNot RecruitingFemale: yes
Male: yes
22Denmark
3EUCTR2012-004071-39-IT
(EUCTR)
16/10/201231/10/2012Study 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.Study on the effectiveness and safety of the treatment of mild-moderate symptomatic hyponatremia due to syndrome of inappropriate secretion of antidiuretic hormone (SIADH) with Tolvaptan vs fluid restriction in patients who underwent transsphenoidal surgery for hypothalamic-pituitary disorders. Mild-moderate symptomatic hyponatremia due to syndrome of inappropriate secretion of antidiuretic hormone (SIADH)
MedDRA version: 14.1;Level: SOC;Classification code 10014698;Term: Endocrine disorders;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: SAMSCA*10CPR 15MG
INN or Proposed INN: TOLVAPTAN
FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANONULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
4EUCTR2012-001169-33-DK
(EUCTR)
02/07/201214/06/2012Effects of the diuretic tolvaptan on nitric oxide systemEffects of tolvaptan on renal sodium and water handling and circulation during inhibition of the nitric oxide system in healthy subjects - SAFA SIADH (Syndrome of inappropriate ADH production)OverhydrationHyponatrimia
MedDRA version: 14.1;Level: LLT;Classification code 10021038;Term: Hyponatremia;System Organ Class: 10027433 - Metabolism and nutrition disorders
MedDRA version: 14.1;Classification code 10040626;Term: SIADH;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Physiological processes [G07]
Trade Name: Samsca
Product Name: Tolvaptan
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN
Department of Medical ResearchNULLNot RecruitingFemale: yes
Male: yes
Denmark
5NCT01228682
(ClinicalTrials.gov)
October 201025/10/2010Post-Authorisation Safety Study of Samsca (Tolvaptan) Used in Routine Medical PracticeA Multi-Centre, Multi-National, Observational Post-Authorisation Safety Study to Document the Drug Utilisation of Samsca and to Collect Information on the Safety of Samsca When Used in Routine Medical PracticeSIADH;Non-SIADH Hyponatremia;Non-HyponatremiaDrug: TolvaptanOtsuka Frankfurt Research Institute GmbHNULLActive, not recruitingN/AN/ABoth200N/ADenmark;Germany;Italy;Norway;Spain;Sweden;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT01227512
(ClinicalTrials.gov)
October 201022/10/2010Effects of Tolvaptan vs Fluid Restriction in Hospitalized Subjects With Dilutional HyponatremiaPhase 3b, Multicenter, Randomized, Single-blind, Parallel Group Trial of the Effects of Titrated Oral SAMSCA(r) (Tolvaptan) 15, 30, or 60 mg QD Compared to Placebo Plus Fluid Restriction on Length of Hospital Stay and Symptoms in Subjects Hospitalized With Dilutional HyponatremiaHyponatremia;Dilutional Hyponatremia;Inappropriate ADH SyndromeDrug: tolvaptan;Other: Fluid RestrictionOtsuka Pharmaceutical Development & Commercialization, Inc.NULLTerminated18 YearsN/AAll124Phase 3United States