SR121463B ( DrugBank: - )
1 disease
| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 72 | Pituitary ADH secretion disorder | 16 |
72. Pituitary ADH secretion disorder
Clinical trials : 41 / Drugs : 27 - (DrugBank : 8) / Drug target genes : 7 - Drug target pathways : 10
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2007-007941-10-BE (EUCTR) | 10/09/2008 | 02/07/2008 | A 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 | A 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 développement | NULL | Not Recruiting | Female: yes Male: yes | 129 | France;Hungary;Belgium;Germany | |||
| 2 | EUCTR2007-007941-10-HU (EUCTR) | 04/08/2008 | 12/06/2008 | A 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 développement | NULL | Not Recruiting | Female: yes Male: yes | 129 | Hungary;Germany;Belgium;France | ||||
| 3 | NCT00728091 (ClinicalTrials.gov) | July 2008 | 31/7/2008 | A Phase III Study Evaluating the Efficacy and Safety of Satavaptan Versus Placebo in Patients With Dilutional Hyponatremia | A 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 Syndrome | Drug: satavaptan (SR121463);Drug: placebo | Sanofi | NULL | Terminated | 18 Years | N/A | Both | 2 | Phase 3 | United States |
| 4 | EUCTR2007-007941-10-FR (EUCTR) | 16/06/2008 | 15/04/2008 | A 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 | A 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 développement | NULL | Not Recruiting | Female: yes Male: yes | 129 | Phase 3 | France;Hungary;Belgium;Germany | ||
| 5 | EUCTR2007-007941-10-DE (EUCTR) | 11/06/2008 | 02/04/2008 | A 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 développement | NULL | Not Recruiting | Female: yes Male: yes | 129 | Hungary;Germany;Belgium;France | ||||
| 6 | EUCTR2004-003985-14-DK (EUCTR) | 19/09/2005 | 05/07/2005 | A 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 | A 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 & développement | NULL | Not Recruiting | Female: yes Male: yes | 108 | Hungary;Denmark;Sweden | |||
| 7 | EUCTR2004-005239-25-DE (EUCTR) | 30/08/2005 | 16/06/2005 | An open-label, multicenter study evaluating the long-term safety and efficacy of SR121463B in patients with Syndrome of Inappropriate Antidiuretic Hormone Secretion. - SIADH Safety | An 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 Research | NULL | Not Recruiting | Female: yes Male: yes | 55 | Hungary;Germany;Spain | |||
| 8 | EUCTR2004-003985-14-SE (EUCTR) | 24/08/2005 | 20/06/2005 | A 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 | A 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 & développement | NULL | Not Recruiting | Female: yes Male: yes | 108 | Hungary;Denmark;Sweden | |||
| 9 | EUCTR2004-005239-25-HU (EUCTR) | 06/07/2005 | 11/05/2005 | An open-label, multicenter study evaluating the long-term safety and efficacy of SR121463B in patients with Syndrome of Inappropriate Antidiuretic Hormone Secretion. - SIADH Safety | An 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 Research | NULL | Not Recruiting | Female: yes Male: yes | 55 | Hungary;Germany;Spain | |||
| 10 | NCT00264914 (ClinicalTrials.gov) | July 2005 | 12/12/2005 | Safety and Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion | An Open-Label, Multicenter Study Evaluating the Long-Term Safety and Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion | Inappropriate ADH Syndrome;Hyponatremia | Drug: SR121463B | Sanofi | NULL | Completed | 18 Years | N/A | Both | 57 | Phase 3 | United States;Australia;Belgium;Brazil;Canada;France;Germany;Hong Kong;Hungary;Russian Federation;Switzerland |
| 11 | EUCTR2004-003985-14-BE (EUCTR) | 09/06/2005 | 20/05/2005 | A 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 | A 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 Research | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Hungary;Belgium;Denmark;Sweden | ||
| 12 | EUCTR2004-003985-14-HU (EUCTR) | 23/05/2005 | 13/04/2005 | A 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 | A 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 Research | NULL | Not Recruiting | Female: yes Male: yes | 150 | Hungary;Denmark;Sweden | |||
| 13 | EUCTR2004-005239-25-ES (EUCTR) | 19/05/2005 | 27/04/2006 | An open-label, multicenter study evaluating the long-term safety and efficacy of SR121463B in patients with Syndrome of Inappropriate Antidiuretic Hormone Secretion. - SIADH Safety | An 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 Research | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Hungary;Spain;Germany | |||
| 14 | EUCTR2004-002349-11-ES (EUCTR) | 03/11/2004 | 14/10/2004 | A 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 | A 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 antidiurética | Product Code: SR121463B INN or Proposed INN: IUPAC INN or Proposed INN: IUPAC | Sanofi-Synthelabo Research | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 3 | Spain | ||
| 15 | NCT00264927 (ClinicalTrials.gov) | May 2004 | 12/12/2005 | Efficacy and Safety of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion | A Randomized, Double-Blind, Placebo-Group, Multicenter Study Evaluating the Efficacy and Safety of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion | Inappropriate ADH Syndrome;Hyponatremia | Drug: SR121463B | Sanofi | NULL | Completed | 18 Years | N/A | Both | 77 | Phase 3 | United States;Belgium;Brazil;Canada;Croatia;Germany;Hong Kong;Hungary;Netherlands;Portugal;Spain |
| 16 | NCT00032734 (ClinicalTrials.gov) | June 2001 | 29/3/2002 | Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion | A 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;Hyponatremia | Drug: satavaptan (SR121463B) | Sanofi | NULL | Completed | 18 Years | N/A | Both | 35 | Phase 2 | Belgium;France;Germany;Hungary;United States;Canada |