Relacorilant ( DrugBank: Relacorilant )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
75クッシング病18

75. クッシング病


臨床試験数 : 205 薬物数 : 176 - (DrugBank : 45) / 標的遺伝子数 : 61 - 標的パスウェイ数 : 127
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05347979
(ClinicalTrials.gov)
May 25, 202218/4/2022Effect of Relacorilant on the Pharmacokinetics of the Sensitive P-glycoprotein Substrate Dabigatran Etexilate in Healthy ParticipantsAn Open-Label, Drug-Drug Interaction Study Designed to Evaluate the Effect of Relacorilant on the Pharmacokinetics of the Sensitive P-glycoprotein Substrate Dabigatran Etexilate in Healthy SubjectsCushing Syndrome;NeoplasmsDrug: Dabigatran Etexilate;Drug: RelacorilantCorcept TherapeuticsNULLCompleted18 Years55 YearsAll30Phase 1United States
2EUCTR2018-001616-30-NL
(EUCTR)
14/04/202212/10/2021Extension of a clinical trial to assess the safety of a study drug called CORT125134 in the treatment of Cushing SyndromeAn Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome - CORT125134-452 Endogenous Cushing Syndrome
MedDRA version: 24.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Physiological processes [G07]
Product Code: CORT125134
INN or Proposed INN: Relacorilant
Other descriptive name: (R)-(1-(4-FLUOROPHENYL)-6-((1-METHYL-1H-PYRAZOL-4-YL)SULFONYL)-4,4A,5,6,7,8-HEXAHYDRO-1H-PYRAZOLO[3,4-G]ISOQUINOLIN-4A-YL)(4-(TRIFLUOROMETHYL)PYRIDIN-2-YL)METHANONE
Corcept Therapeutics IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2;Phase 3United States;Hungary;Canada;Spain;Poland;Romania;Austria;Bulgaria;Israel;Germany;Netherlands;Italy
3EUCTR2018-001616-30-RO
(EUCTR)
29/12/202128/04/2022Extension of a clinical trial to assess the safety of a study drug called CORT125134 in the treatment of Cushing SyndromeAn Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome Endogenous Cushing Syndrome
MedDRA version: 24.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Physiological processes [G07]
Product Code: CORT125134
INN or Proposed INN: Relacorilant
Other descriptive name: (R)-(1-(4-FLUOROPHENYL)-6-((1-METHYL-1H-PYRAZOL-4-YL)SULFONYL)-4,4A,5,6,7,8-HEXAHYDRO-1H-PYRAZOLO[3,4-G]ISOQUINOLIN-4A-YL)(4-(TRIFLUOROMETHYL)PYRIDIN-2-YL)METHANONE
Corcept Therapeutics IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2;Phase 3United States;Hungary;Canada;Spain;Poland;Romania;Austria;Bulgaria;Israel;Netherlands;Germany;Italy
4EUCTR2018-001616-30-DE
(EUCTR)
22/12/202016/03/2020Extension of a clinical trial to assess the safety of a study drug called CORT125134 in the treatment of Cushing SyndromeAn Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome Endogenous Cushing Syndrome
MedDRA version: 24.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Physiological processes [G07]
Product Code: CORT125134
INN or Proposed INN: Relacorilant
Other descriptive name: (R)-(1-(4-FLUOROPHENYL)-6-((1-METHYL-1H-PYRAZOL-4-YL)SULFONYL)-4,4A,5,6,7,8-HEXAHYDRO-1H-PYRAZOLO[3,4-G]ISOQUINOLIN-4A-YL)(4-(TRIFLUOROMETHYL)PYRIDIN-2-YL)METHANONE
Corcept Therapeutics IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2;Phase 3United States;Hungary;Canada;Spain;Poland;Romania;Austria;Bulgaria;Israel;Netherlands;Germany;Italy
5EUCTR2018-001616-30-BG
(EUCTR)
27/03/202024/02/2020Extension of a clinical trial to assess the safety of a study drug called CORT125134 in the treatment of Cushing SyndromeAn Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome Endogenous Cushing Syndrome
MedDRA version: 24.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Physiological processes [G07]
Product Code: CORT125134
INN or Proposed INN: Relacorilant
Other descriptive name: (R)-(1-(4-FLUOROPHENYL)-6-((1-METHYL-1H-PYRAZOL-4-YL)SULFONYL)-4,4A,5,6,7,8-HEXAHYDRO-1H-PYRAZOLO[3,4-G]ISOQUINOLIN-4A-YL)(4-(TRIFLUOROMETHYL)PYRIDIN-2-YL)METHANONE
Corcept Therapeutics IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2;Phase 3United States;Hungary;Canada;Spain;Poland;Romania;Austria;Israel;Bulgaria;Netherlands;Germany;Italy
6EUCTR2018-001616-30-ES
(EUCTR)
14/02/202010/01/2020Extension of a clinical trial to assess the safety of a study drug called CORT125134 in the treatment of Cushing SyndromeAn Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome Endogenous Cushing Syndrome
MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Physiological processes [G07]
Product Code: CORT125134
INN or Proposed INN: Relacorilant
Other descriptive name: (R)-(1-(4-FLUOROPHENYL)-6-((1-METHYL-1H-PYRAZOL-4-YL)SULFONYL)-4,4A,5,6,7,8-HEXAHYDRO-1H-PYRAZOLO[3,4-G]ISOQUINOLIN-4A-YL)(4-(TRIFLUOROMETHYL)PYRIDIN-2-YL)METHANONE
Corcept Therapeutics IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2;Phase 3Canada;Austria;Netherlands;Romania;Hungary;United States;Poland;Italy;Israel;Bulgaria;Germany;Spain
7EUCTR2018-003096-35-PL
(EUCTR)
05/07/201912/04/2019A study to assess whether a product called relacorilant works and is safe to use in patients with Cushing Syndrome; some patients will receive relacorilant whilst others receive a placebo.Glucocorticoid Receptor Antagonism in the Treatment of Cushing Syndrome (GRACE): A Phase 3, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Study of the Efficacy and Safety of Relacorilant - GRACE Endogenous Cushing syndrome
MedDRA version: 24.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Physiological processes [G07]
Product Name: Relacorilant
Product Code: CORT125134
INN or Proposed INN: Relacorilant
Other descriptive name: (R)-(1-(4-FLUOROPHENYL)-6-((1-METHYL-1H-PYRAZOL-4YL)SULFONYL)4,4A,5,6,7,8HEXAHYDRO-1H-PYRAZOLO[3,4-G]ISOQUINOLIN4AYL)(4(TRIFLUOROMETHYL)PYRIDIN-2-YL)METHANONE
Corcept Therapeutics IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
145Phase 3Canada;Austria;Netherlands;Romania;United States;Poland;Italy;Israel;Bulgaria;Germany;Spain
8EUCTR2018-003096-35-NL
(EUCTR)
19/06/201911/12/2018A study to assess whether a product called relacorilant works and is safe to use in patients with Cushing Syndrome; some patients will receive relacorilant whilst others receive a placebo.Glucocorticoid Receptor Antagonism in the Treatment of Cushing Syndrome (GRACE): A Phase 3, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Study of the Efficacy and Safety of Relacorilant - CORT125134-455 Endogenous Cushing syndrome
MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Physiological processes [G07]
Product Name: Relacorilant
Product Code: CORT125134
INN or Proposed INN: Relacorilant
Other descriptive name: (R)-(1-(4-FLUOROPHENYL)-6-((1-METHYL-1H-PYRAZOL-4-YL)SULFONYL)4,4A,5,6,7,8-HEXAHYDRO-1H-PYRAZOLO[3,4-G]ISOQUINOLIN-4A-YL)(4(TRIFLUOROMETHYL)PYRIDIN-2-YL)METHANONE
Corcept Therapeutics IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3United States;Canada;Spain;Poland;Romania;Austria;Bulgaria;Israel;Germany;Netherlands;Italy
9EUCTR2018-003096-35-BG
(EUCTR)
05/06/201928/01/2019A study to assess whether a product called relacorilant works and is safe to use in patients with Cushing Syndrome; some patients will receive relacorilant whilst others receive a placebo.Glucocorticoid Receptor Antagonism in the Treatment of Cushing Syndrome (GRACE): A Phase 3, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Study of the Efficacy and Safety of Relacorilant - GRACE Endogenous Cushing syndrome
MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Physiological processes [G07]
Product Name: Relacorilant
Product Code: CORT125134
INN or Proposed INN: Relacorilant
Other descriptive name: (R)-(1-(4-FLUOROPHENYL)-6-((1-METHYL-1H-PYRAZOL-4-YL)SULFONYL)4,4A,5,6,7,8-HEXAHYDRO-1H-PYRAZOLO[3,4-G]ISOQUINOLIN-4A-YL)(4(TRIFLUOROMETHYL)PYRIDIN-2-YL)METHANONE
Corcept Therapeutics IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
145Phase 3United States;Canada;Spain;Poland;Romania;Austria;Israel;Bulgaria;Netherlands;Germany;Italy
10EUCTR2018-003096-35-AT
(EUCTR)
31/05/201915/02/2019A study to assess whether a product called relacorilant works and is safe to use in patients with Cushing Syndrome; some patients will receive relacorilant whilst others receive a placebo.Glucocorticoid Receptor Antagonism in the Treatment of Cushing Syndrome (GRACE): A Phase 3, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Study of the Efficacy and Safety of Relacorilant - GRACE Endogenous Cushing syndrome
MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Physiological processes [G07]
Product Name: Relacorilant
Product Code: CORT125134
INN or Proposed INN: Relacorilant
Other descriptive name: (R)-(1-(4-FLUOROPHENYL)-6-((1-METHYL-1H-PYRAZOL-4-YL)SULFONYL)4,4A,5,6,7,8-HEXAHYDRO-1H-PYRAZOLO[3,4-G]ISOQUINOLIN-4A-YL)(4(TRIFLUOROMETHYL)PYRIDIN-2-YL)METHANONE
Corcept Therapeutics IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
145Phase 3United States;Canada;Spain;Poland;Romania;Austria;Bulgaria;Israel;Netherlands;Germany;Italy
11EUCTR2018-003096-35-ES
(EUCTR)
23/05/201912/04/2019A study to assess whether a product call relacorilant works and is safe to use in patients with Cushing Syndrome; some patients will receive relacorilant whilst others receive a placebo.Glucocorticoid Receptor Antagonism in the Treatment of Cushing Syndrome (GRACE): A Phase 3, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Study of the Efficacy and Safety of Relacorilant - GRACE Endogenous Cushing syndrome
MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860 ;Therapeutic area: Body processes [G] - Physiological processes [G07]
Product Name: Relacorilant
Product Code: CORT125134
INN or Proposed INN: Relacorilant
Other descriptive name: (R)-(1-(4-FLUOROPHENYL)-6-((1-METHYL-1H-PYRAZOL-4-YL)SULFONYL)4,4A,5,6,7,8-HEXAHYDRO-1H-PYRAZOLO[3,4-G]ISOQUINOLIN-4A-YL)(4(TRIFLUOROMETHYL)PYRIDIN-2-YL)METHANONE
Corcept Therapeutics IncorporatedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
130 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Canada;Poland;Spain;Austria;Israel;Bulgaria;Netherlands;Germany;Italy
12EUCTR2018-003096-35-IT
(EUCTR)
21/02/201927/01/2021A study to assess whether a product called relacorilant works and is safe to use in patients with Cushing Syndrome; some patients will receive relacorilant whilst others receive a placebo.Glucocorticoid Receptor Antagonism in the Treatment of Cushing Syndrome (GRACE): A Phase 3, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Study of the Efficacy and Safety of Relacorilant - GRACE Endogenous Cushing syndrome
MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Physiological processes [G07]
Product Name: Relacorilant
Product Code: [CORT125134]
INN or Proposed INN: Relacorilant
Other descriptive name: (R)-(1-(4-FLUOROPHENYL)-6-((1-METHYL-1H-PYRAZOL-4-
CORCEPT THERAPEUTICSNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
145Phase 3United States;Canada;Spain;Poland;Romania;Austria;Bulgaria;Israel;Netherlands;Germany;Italy
13NCT03697109
(ClinicalTrials.gov)
October 16, 201827/9/2018A Study of the Efficacy and Safety of Relacorilant in Patients With Endogenous Cushing SyndromeGlucocorticoid Receptor Antagonism in the Treatment of Cushing Syndrome (GRACE): A Phase 3, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Study of the Efficacy and Safety of RelacorilantCushing SyndromeDrug: Relacorilant;Other: PlaceboCorcept TherapeuticsNULLRecruiting18 Years80 YearsAll130Phase 3United States;Austria;Bulgaria;Canada;Germany;Israel;Italy;Netherlands;Poland;Romania;Spain
14EUCTR2018-001616-30-IT
(EUCTR)
19/07/201829/01/2021Extension of a clinical trial to assess the safety of a study drug called CORT125134 in the treatment of Cushing SyndromeAn Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome - - Endogenous Cushing Syndrome
MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Physiological processes [G07]
Trade Name: NA
Product Name: NA
Product Code: [CORT125134]
INN or Proposed INN: Relacorilant
CORCEPT THERAPEUTICSNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2United States;Hungary;Spain;Bulgaria;Germany;Italy
15EUCTR2018-001616-30-HU
(EUCTR)
09/07/201814/05/2018Extension of a clinical trial to assess the safety of a study drug called CORT125134 in the treatment of Cushing SyndromeAn Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome Endogenous Cushing Syndrome
MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Physiological processes [G07]
Product Code: CORT125134
INN or Proposed INN: Relacorilant
Other descriptive name: (R)-(1-(4-FLUOROPHENYL)-6-((1-METHYL-1H-PYRAZOL-4-YL)SULFONYL)-4,4A,5,6,7,8-HEXAHYDRO-1H-PYRAZOLO[3,4-G]ISOQUINOLIN-4A-YL)(4-(TRIFLUOROMETHYL)PYRIDIN-2-YL)METHANONE
Corcept Therapeutics IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2United States;Hungary;Italy
16NCT03604198
(ClinicalTrials.gov)
May 7, 20181/5/2018Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing SyndromeAn Open-Label Extension Study of the Safety of Relacorilant in the Treatment of the Signs and Symptoms of Cushing SyndromeCushing SyndromeDrug: relacorilantCorcept TherapeuticsNULLEnrolling by invitationN/AN/AAll75Phase 2United States;Austria;Bulgaria;Germany;Israel;Italy;Netherlands;Poland;Romania;Spain
17EUCTR2016-000899-23-GB
(EUCTR)
16/08/201621/06/2016Clinical trial to assess the safety and effectiveness of a study drug called CORT125134 in the treatment of Cushing's syndromePhase 2 Study of the Safety and Efficacy of CORT125134 in the Treatment of Endogenous Cushing’s Syndrome Endogenous Cushing’s Syndrome
MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860 ;Therapeutic area: Body processes [G] - Physiological processes [G07]
Product Code: CORT125134
INN or Proposed INN: Relacorilant
Corcept Therapeutics IncorporatedNULLNot Recruiting Female: yes
Male: yes
30 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Hungary;Netherlands;United Kingdom
18EUCTR2018-003096-35-DE
(EUCTR)
14/06/2019A study to assess whether a product called relacorilant works and is safe to use in patients with Cushing Syndrome; some patients will receive relacorilant whilst others receive a placebo.Glucocorticoid Receptor Antagonism in the Treatment of Cushing Syndrome (GRACE): A Phase 3, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Study of the Efficacy and Safety of Relacorilant - GRACE Endogenous Cushing syndrome
MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Physiological processes [G07]
Product Name: Relacorilant
Product Code: CORT125134
INN or Proposed INN: Relacorilant
Other descriptive name: (R)-(1-(4-FLUOROPHENYL)-6-((1-METHYL-1H-PYRAZOL-4-YL)SULFONYL)4,4A,5,6,7,8-HEXAHYDRO-1H-PYRAZOLO[3,4-G]ISOQUINOLIN-4A-YL)(4(TRIFLUOROMETHYL)PYRIDIN-2-YL)METHANONE
Corcept Therapeutics IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
145Phase 3Canada;Austria;Netherlands;Romania;United States;Poland;Italy;Israel;Bulgaria;Germany;Spain