SR121463B ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
72下垂体性ADH分泌異常症16

72. 下垂体性ADH分泌異常症


臨床試験数 : 41 薬物数 : 27 - (DrugBank : 8) / 標的遺伝子数 : 7 - 標的パスウェイ数 : 10
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2007-007941-10-BE
(EUCTR)
10/09/200802/07/2008A Double-Blind, Randomized, Placebo-Controlled Multicenter Study Evaluating the Efficacy and Safety of two doses of Satavaptan (SR121463B) Versus Placebo in Patients with Dilutional Hyponatremia due to the Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) - AQUARIST IA Double-Blind, Randomized, Placebo-Controlled Multicenter Study Evaluating the Efficacy and Safety of two doses of Satavaptan (SR121463B) Versus Placebo in Patients with Dilutional Hyponatremia due to the Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) - AQUARIST I Dilutional hyponatraemia. MedRA term HYPONATRAEMIA
MedDRA version: 10.1;Level: LLT;Classification code 10021036;Term:
Product Name: satavaptan
Product Code: SR121463B
INN or Proposed INN: satavaptan
Product Name: satavaptan
Product Code: SR121463B
INN or Proposed INN: satavaptan
sanofi-aventis recherche et développementNULLNot RecruitingFemale: yes
Male: yes
129France;Hungary;Belgium;Germany
2EUCTR2007-007941-10-HU
(EUCTR)
04/08/200812/06/2008A Double-Blind, Randomized, Placebo-Controlled Multicenter Study Evaluating the Efficacy and Safety of two doses of Satavaptan (SR121463B) Versus Placebo in Patients with Dilutional Hyponatremia due to the Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) - AQUARIST I Dilutional hyponatraemia. MedRA term HYPONATRAEMIA
MedDRA version: 9.1;Level: LLT;Classification code 10021036;Term: Hyponatraemia
Product Name: satavaptan
Product Code: SR121463B
INN or Proposed INN: satavaptan
Product Name: satavaptan
Product Code: SR121463B
INN or Proposed INN: satavaptan
sanofi-aventis recherche et développementNULLNot RecruitingFemale: yes
Male: yes
129Hungary;Germany;Belgium;France
3NCT00728091
(ClinicalTrials.gov)
July 200831/7/2008A Phase III Study Evaluating the Efficacy and Safety of Satavaptan Versus Placebo in Patients With Dilutional HyponatremiaA Double-Blind, Randomized, Placebo-Controlled Multicenter Study Evaluating the Efficacy and Safety of Two Doses of Satavaptan (SR121463B) Versus Placebo in Patients With Dilutional Hyponatremia Due to the Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)Hyponatremia;Inappropriate ADH SyndromeDrug: satavaptan (SR121463);Drug: placeboSanofiNULLTerminated18 YearsN/ABoth2Phase 3United States
4EUCTR2007-007941-10-FR
(EUCTR)
16/06/200815/04/2008A Double-Blind, Randomized, Placebo-Controlled Multicenter Study Evaluating the Efficacy and Safety of two doses of Satavaptan (SR121463B) Versus Placebo in Patients with Dilutional Hyponatremia due to the Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) - AQUARIST IA Double-Blind, Randomized, Placebo-Controlled Multicenter Study Evaluating the Efficacy and Safety of two doses of Satavaptan (SR121463B) Versus Placebo in Patients with Dilutional Hyponatremia due to the Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) - AQUARIST I Dilutional hyponatraemia. MedRA term HYPONATRAEMIA
MedDRA version: 10.1;Level: LLT;Classification code 10021036;Term:
Product Name: satavaptan
Product Code: SR121463B
INN or Proposed INN: satavaptan
Product Name: satavaptan
Product Code: SR121463B
INN or Proposed INN: satavaptan
sanofi-aventis recherche et développementNULLNot RecruitingFemale: yes
Male: yes
129Phase 3France;Hungary;Belgium;Germany
5EUCTR2007-007941-10-DE
(EUCTR)
11/06/200802/04/2008A Double-Blind, Randomized, Placebo-Controlled Multicenter Study Evaluating the Efficacy and Safety of two doses of Satavaptan (SR121463B) Versus Placebo in Patients with Dilutional Hyponatremia due to the Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) - AQUARIST I Dilutional hyponatraemia. MedRA term HYPONATRAEMIA
MedDRA version: 10.1;Level: LLT;Classification code 10021036;Term:
Product Name: satavaptan
Product Code: SR121463B
INN or Proposed INN: satavaptan
Product Name: satavaptan
Product Code: SR121463B
INN or Proposed INN: satavaptan
sanofi-aventis recherche et développementNULLNot RecruitingFemale: yes
Male: yes
129Hungary;Germany;Belgium;France
6EUCTR2004-003985-14-DK
(EUCTR)
19/09/200505/07/2005A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial Evaluating the Effect of a Vasopressin V2 Receptor Antagonist (SR121463B) on Serum Sodium in Patients with Dilutional Hyponatremia - Dilutional HyponatremiaA Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial Evaluating the Effect of a Vasopressin V2 Receptor Antagonist (SR121463B) on Serum Sodium in Patients with Dilutional Hyponatremia - Dilutional Hyponatremia Dilutional hyponatremia excluding chronic syndrome of inappropriate antidiuretic hormone secretion (SIADH) or cirrhosis
MedDRA version: 7.1;Level: LLT;Classification code 10021038
Product Name: NA
Product Code: SR121463B
INN or Proposed INN: NA
Product Name: NA
Product Code: SR121463B
INN or Proposed INN: NA
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
108Hungary;Denmark;Sweden
7EUCTR2004-005239-25-DE
(EUCTR)
30/08/200516/06/2005An open-label, multicenter study evaluating the long-term safety and efficacy of SR121463B in patients with Syndrome of Inappropriate Antidiuretic Hormone Secretion. - SIADH SafetyAn open-label, multicenter study evaluating the long-term safety and efficacy of SR121463B in patients with Syndrome of Inappropriate Antidiuretic Hormone Secretion. - SIADH Safety Syndrome of Inappropriate Antidiuretic Hormone (SIADH) with serum sodium between 115 and 132 mmol/L.
MedDRA version: 7.1;Level: LLT;Classification code 10040626
Product Name: NA
Product Code: SR121463B
INN or Proposed INN: NA
Product Name: NA
Product Code: SR121463B
INN or Proposed INN: NA
Product Name: NA
Product Code: SR121463B
INN or Proposed INN: NA
Sanofi-Synthelabo ResearchNULLNot RecruitingFemale: yes
Male: yes
55Hungary;Germany;Spain
8EUCTR2004-003985-14-SE
(EUCTR)
24/08/200520/06/2005A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial Evaluating the Effect of a Vasopressin V2 Receptor Antagonist (SR121463B) on Serum Sodium in Patients with Dilutional Hyponatremia - Dilutional HyponatremiaA Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial Evaluating the Effect of a Vasopressin V2 Receptor Antagonist (SR121463B) on Serum Sodium in Patients with Dilutional Hyponatremia - Dilutional Hyponatremia Dilutional hyponatremia excluding chronic syndrome of inappropriate antidiuretic hormone secretion (SIADH) or cirrhosis
MedDRA version: 7.1;Level: LLT;Classification code 10021038
Product Name: NA
Product Code: SR121463B
INN or Proposed INN: NA
Product Name: NA
Product Code: SR121463B
INN or Proposed INN: NA
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
108Hungary;Denmark;Sweden
9EUCTR2004-005239-25-HU
(EUCTR)
06/07/200511/05/2005An open-label, multicenter study evaluating the long-term safety and efficacy of SR121463B in patients with Syndrome of Inappropriate Antidiuretic Hormone Secretion. - SIADH SafetyAn open-label, multicenter study evaluating the long-term safety and efficacy of SR121463B in patients with Syndrome of Inappropriate Antidiuretic Hormone Secretion. - SIADH Safety Syndrome of Inappropriate Antidiuretic Hormone (SIADH) with serum sodium between 115 and 132 mmol/L.
MedDRA version: 7.1;Level: LLT;Classification code 10040626
Product Name: NA
Product Code: SR121463B
INN or Proposed INN: NA
Product Name: NA
Product Code: SR121463B
INN or Proposed INN: NA
Product Name: NA
Product Code: SR121463B
INN or Proposed INN: NA
Sanofi-Synthelabo ResearchNULLNot RecruitingFemale: yes
Male: yes
55Hungary;Germany;Spain
10NCT00264914
(ClinicalTrials.gov)
July 200512/12/2005Safety and Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone SecretionAn Open-Label, Multicenter Study Evaluating the Long-Term Safety and Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone SecretionInappropriate ADH Syndrome;HyponatremiaDrug: SR121463BSanofiNULLCompleted18 YearsN/ABoth57Phase 3United States;Australia;Belgium;Brazil;Canada;France;Germany;Hong Kong;Hungary;Russian Federation;Switzerland
11EUCTR2004-003985-14-BE
(EUCTR)
09/06/200520/05/2005A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial Evaluating the Effect of a Vasopressin V2 Receptor Antagonist (SR121463B) on Serum Sodium in Patients with Dilutional Hyponatremia - DILIPOA Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial Evaluating the Effect of a Vasopressin V2 Receptor Antagonist (SR121463B) on Serum Sodium in Patients with Dilutional Hyponatremia - DILIPO Dilutional hyponatremia excluding known syndrome of inappropriate antidiuretic hormone secretion (SIADH) or cirrhosis
MedDRA version: 7.1;Level: LLT;Classification code 10021038
Trade Name: NA
Product Name: NA
Product Code: SR121463B
INN or Proposed INN: NA
Trade Name: NA
Product Name: NA
Product Code: SR121463B
INN or Proposed INN: NA
Sanofi-Synthelabo ResearchNULLNot RecruitingFemale: yes
Male: yes
150Phase 3Hungary;Belgium;Denmark;Sweden
12EUCTR2004-003985-14-HU
(EUCTR)
23/05/200513/04/2005A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial Evaluating the Effect of Two Doses of a Vasopressin V2 Receptor Antagonist (SR121463B) on Serum Sodium in Patients with Dilutional Hyponatremia - Dilutional HyponatremiaA Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial Evaluating the Effect of Two Doses of a Vasopressin V2 Receptor Antagonist (SR121463B) on Serum Sodium in Patients with Dilutional Hyponatremia - Dilutional Hyponatremia Dilutional hyponatremia excluding chronic syndrome of inappropriate antidiuretic hormone secretion (SIADH) or cirrhosis
MedDRA version: 7.1;Level: LLT;Classification code 10021038
Product Name: NA
Product Code: SR121463B
INN or Proposed INN: NA
Product Name: NA
Product Code: SR121463B
INN or Proposed INN: NA
Sanofi-Synthelabo ResearchNULLNot RecruitingFemale: yes
Male: yes
150Hungary;Denmark;Sweden
13EUCTR2004-005239-25-ES
(EUCTR)
19/05/200527/04/2006An open-label, multicenter study evaluating the long-term safety and efficacy of SR121463B in patients with Syndrome of Inappropriate Antidiuretic Hormone Secretion. - SIADH SafetyAn open-label, multicenter study evaluating the long-term safety and efficacy of SR121463B in patients with Syndrome of Inappropriate Antidiuretic Hormone Secretion. - SIADH Safety Syndrome of Inappropriate Antidiuretic Hormone (SIADH) with serum sodium between 115 and 132 mmol/L.
MedDRA version: 7.1;Level: LLT;Classification code 10040626
Product Name: NA
Product Code: SR121463B
INN or Proposed INN: NA
Product Name: NA
Product Code: SR121463B
INN or Proposed INN: NA
Product Name: NA
Product Code: SR121463B
INN or Proposed INN: NA
Sanofi-Synthelabo ResearchNULLNot RecruitingFemale: yes
Male: yes
Phase 3Hungary;Spain;Germany
14EUCTR2004-002349-11-ES
(EUCTR)
03/11/200414/10/2004A randomisation, double-blind, placebo-controlled, parallel-group, multicenter study evaluating the efficacy and safety of SR121463B in patients with syndrome of inappropriate antidiuretic hormone secretion. - SIADHA randomisation, double-blind, placebo-controlled, parallel-group, multicenter study evaluating the efficacy and safety of SR121463B in patients with syndrome of inappropriate antidiuretic hormone secretion. - SIADH Síndrome de secreción inadecuada de hormona antidiuréticaProduct Code: SR121463B
INN or Proposed INN: IUPAC
INN or Proposed INN: IUPAC
Sanofi-Synthelabo ResearchNULLNot RecruitingFemale: yes
Male: yes
75Phase 3Spain
15NCT00264927
(ClinicalTrials.gov)
May 200412/12/2005Efficacy and Safety of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone SecretionA Randomized, Double-Blind, Placebo-Group, Multicenter Study Evaluating the Efficacy and Safety of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone SecretionInappropriate ADH Syndrome;HyponatremiaDrug: SR121463BSanofiNULLCompleted18 YearsN/ABoth77Phase 3United States;Belgium;Brazil;Canada;Croatia;Germany;Hong Kong;Hungary;Netherlands;Portugal;Spain
16NCT00032734
(ClinicalTrials.gov)
June 200129/3/2002Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone SecretionA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Escalation, Multicenter Study Evaluating the Efficacy and Safety of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion.Syndrome of Inappropriate ADH (SIADH) Secretion;HyponatremiaDrug: satavaptan (SR121463B)SanofiNULLCompleted18 YearsN/ABoth35Phase 2Belgium;France;Germany;Hungary;United States;Canada