75. クッシング病
[臨床試験数:191,薬物数:172(DrugBank:48),標的遺伝子数:61,標的パスウェイ数:121

Searched query = "Cushing disease", "Cushing"
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.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
32 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04569591
(ClinicalTrials.gov)
December 17, 202029/9/2020Corticotrophin-releasing Hormone (CRH) Stimulation for 18F-FDG-PET Detection of Pituitary Adenoma in Cushing s DiseaseCorticotrophin-Releasing Hormone (CRH) Stimulation for 18F-FDG-PET Detection of Pituitary Adenoma in Cushing's DiseaseCushing's Disease;Pituitary AdenomaDrug: ActhrelNational Institute of Neurological Disorders and Stroke (NINDS)NULLRecruiting8 YearsN/AAll22N/AUnited States
2NCT04339751
(ClinicalTrials.gov)
December 17, 20208/4/2020Effect of Vorinostat on ACTH Producing Pituitary Adenomas in Cushing s DiseaseThe Effect of Vorinostat on ACTH Producing Pituitary Adenomas in Cushing s DiseaseCushing's DiseaseDrug: VorinostatNational Institute of Neurological Disorders and Stroke (NINDS)NULLRecruiting18 YearsN/AAll22Phase 2United States
3NCT03346954
(ClinicalTrials.gov)
December 11, 201715/11/2017Impact of [11C]-Methionine PET/MRI in the Detection of Pituitary Adenomas Secreting ACTH and Causing Cushing's DiseaseImpact of [11C]-Methionine PET/MRI in the Detection of Pituitary Adenomas Secreting ACTH and Causing Cushing's DiseaseCushing's DiseaseOther: [11C]-Methionine PET/MRIHospices Civils de LyonNULLCompleted18 YearsN/AAll33N/AFrance
4ChiCTR-OPC-17011664
2017-08-012017-06-14A single center clinical study of EGFR/HER2 targeted inhibitor Lapatinib in the treatment of refractory Cushing's diseaseA single center clinical study of EGFR/HER2 targeted inhibitor Lapatinib in the treatment of refractory Cushing's disease Pituitary ACTH-secreting adenomaTreatment group:lapatinib;Peking Union Medical College HospitalNULLPending1875BothTreatment group:30;China
5EUCTR2013-000267-84-PL
(EUCTR)
05/02/201616/12/2015Study to roll over patients who have completed a study with pasireotide and benefit from the study treatment.An open label, multicenter pasireotide roll over protocol for patients who have completed a previous Novartis sponsored pasireotide study and are judged by the investigator to benefit from continued pasireotide treatment - Roll over protocol with pasireotide Cushing's diseaseAcromegalyNeuroendocrine tumorsPituitary tumorsEctopic ACTH secreting (EAS) tumorsDumping SyndromeProstate cancerMelanoma negative for bRAF
MedDRA version: 21.0;Level: LLT;Classification code 10062476;Term: Neuroendocrine tumor;System Organ Class: 100000004864
MedDRA version: 20.0;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860
MedDRA version: 20.0;Classification code 10000600;Term: Acromegaly and gigantism;System Organ Class: 100000004860;Therapeutic area: Not possible to specify
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: PASIREOTIDE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: PASIREOTIDE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: PASIREOTIDE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: PASIREOTIDE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: PASIREOTIDE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 4Portugal;United States;Taiwan;Greece;Thailand;Spain;Israel;Russian Federation;Italy;France;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Australia;Bulgaria;Netherlands;China;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT02468193
(ClinicalTrials.gov)
September 24, 20158/6/2015Study of Efficacy and Safety of Osilodrostat in Cushing's SyndromeA Phase II, Open-label, Dose Titration, Multi-center Study to Assess the Safety/Tolerability and Efficacy of Osilodrostat in Patients With All Types of Endogenous Cushing's Syndrome Except Cushing's DiseaseCushing's Syndrome;Ectopic Corticotropin Syndrome;Adrenal Adenoma;Adrenal Carcinoma;AIMAH;PPNADDrug: OsilodrostatNovartis PharmaceuticalsNULLCompleted18 Years85 YearsAll9Phase 2Japan
7NCT02019706
(ClinicalTrials.gov)
February 12, 201421/12/2013Evaluation of 68Ga-DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Patients With Ectopic Cushing SyndromeEvaluation of 68Ga -DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Patients With Ectopic Cushing SyndromeACTH;Cushing's SyndromeRadiation: DOTATATE PET-CT;Radiation: F-DOPA PET CT;Diagnostic Test: CT scan;Diagnostic Test: MRIEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Recruiting18 Years90 YearsAll80Phase 1/Phase 2United States
8EUCTR2013-002063-26-IT
(EUCTR)
08/09/201323/07/2013A trial with Metyrapone in Cushing's syndromeA prospective open-label Phase 2 study of METYRAPONE as a preoperative treatment in patients with ACTH-independent Cushing’s syndrome due to adrenal adenoma. - METYX01 Cushing's syndrome;Therapeutic area: Diseases [C] - Hormonal diseases [C19]Trade Name: Matyrapone
Product Name: Metyrapone
Product Code: Metyrapone
S.C.D.U. MEDICINA INTERNA 1 Ospedale San Luigi OrbassanoNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
15Phase 2Italy
9EUCTR2013-000267-84-FR
(EUCTR)
07/08/201323/09/2015An open label, multicenter pasireotide roll over protocol for patients who have completed a previous Novartis sponsored pasireotide study and are judged by the investigator to benefit from continued pasireotide treatmentAn open label, multicenter pasireotide roll over protocol for patients who have completed a previous Novartis sponsored pasireotide study and are judged by the investigator to benefit from continued pasireotide treatment Cushing’s diseaseAcromegalyNeuroendocrine tumorsPituitary tumorsEctopic ACTH secreting (EAS) tumorsDumping SyndromeProstate cancerMelanoma negative for bRAFTrade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Novartis Pharma Services AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100United States;Greece;Spain;Thailand;Russian Federation;Israel;Italy;France;Mexico;Canada;Belgium;Brazil;Australia;Germany;Norway;China
10NCT01794793
(ClinicalTrials.gov)
June 10, 201315/2/2013Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in Novartis-sponsored StudiesAn Open Label, Multi-center Pasireotide Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Pasireotide Study and Are Judged by the Investigator to Benefit From Continued Pasireotide TreatmentCushing's Disease;Acromegaly;Neuroendocrine Tumors;Pituitary Tumors;Ectopic ACTH Secreting (EAS) Tumors;Dumping Syndrome;Prostate Cancer;Melanoma Negative for bRAF;Melanoma Negative for nRASDrug: Pasireotide;Drug: CabergolineRECORDATI GROUPNULLActive, not recruiting18 YearsN/AAll413Phase 4United States;Argentina;Belgium;Brazil;Bulgaria;Canada;France;Germany;Greece;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Malaysia;Mexico;Netherlands;Peru;Poland;Portugal;Romania;Russian Federation;Spain;Switzerland;Taiwan;Thailand;Turkey;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2011-003264-77-NL
(EUCTR)
31/10/201107/09/2011A study with ketoconazole and octreotide combination therapy for treatment of Cushing’s disease.A prospective trial with ketoconazole and octreotide combination therapy for treatment of Cushing’s disease. - Octreotide and ketoconazole for Cushing's disease Cushing's disease (which is caused by an ACTH producing pituitary adenoma)
MedDRA version: 14.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Octreotide
Product Name: Octreotide
Product Code: RVG 18236
Trade Name: Ketoconazole
Product Name: Ketoconazole
Product Code: RVG 08938
Trade Name: Cabergoline
Product Name: Cabergoline
Product Code: RVG 15375
Erasmus MCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
12NCT01459237
(ClinicalTrials.gov)
October 11, 201121/10/2011Effects of Hormone Stimulation on Brain Scans for Cushing s DiseaseProspective Evaluation of the Effect of Corticotropin-Releasing Hormone Stimulation on 18F-Fludeoxyglucose High-Resolution Positron-Emission Tomography in Cushing's DiseasePituitary NeoplasmDrug: ActhrelNational Institute of Neurological Disorders and Stroke (NINDS)NULLCompleted8 YearsN/AAll30Early Phase 1United States
13EUCTR2010-018720-12-SE
(EUCTR)
22/04/201018/02/2010Behandling med kabergolin hos patienter med ACTH-beroende Cushing´s syndrom(treatment with cabergoline in patients with ACTH-dependent Cushing´s syndrome - Cushing and cabergolineBehandling med kabergolin hos patienter med ACTH-beroende Cushing´s syndrom(treatment with cabergoline in patients with ACTH-dependent Cushing´s syndrome - Cushing and cabergoline A) Men and women aged 18 to 75 years with hypercortisolism due to ACTH-dependent Cushing's syndrome will be treated in the period between diagnosis and planned surgery or radiation therapy.B) Men and women aged 18 to 75 years due to ACTH-dependent Cushing's syndrome who have persistent hypercortisolism post-surgery or post-radiotherapy.Product Name: cabergolineSwedish Pituitary Study groupNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Sweden
14EUCTR2006-004111-22-HU
(EUCTR)
29/10/200822/07/2008A randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing’s diseaseA randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing’s disease Cushing’s disease is rare disease that is caused by an adrenocorticotropic hormone (ACTH) secreting pituitary adenoma. The elevated ACTH secreted by these tumors stimulates the adrenal glands to produce excess cortisol, leading to the subsequent development of the clinical signs and symptoms of hypercortisolism. Cushing's disease is associated with severe morbidity and premature mortality and most commonly affects adults aged 20-50, primarily females
MedDRA version: 8.1;Level: LLT;Classification code 10011651;Term: Cushing's disease
Product Name: pasireotide
Product Code: SOM230B
INN or Proposed INN: pasireotide
Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
146Portugal;Hungary;Greece;Finland;Belgium;Denmark;Germany;United Kingdom;Italy
15EUCTR2006-004111-22-GB
(EUCTR)
19/03/200820/03/2008A randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing’s diseaseA randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing’s disease Cushing’s disease is rare disease that is caused by an adrenocorticotropic hormone (ACTH) secreting pituitary adenoma. The elevated ACTH secreted by these tumors stimulates the adrenal glands to produce excess cortisol, leading to the subsequent development of the clinical signs and symptoms of hypercortisolism. Cushing's disease is associated with severe morbidity and premature mortality and most commonly affects adults aged 20-50, primarily females
MedDRA version: 8.1;Level: LLT;Classification code 10011651;Term: Cushing's disease
Product Name: pasireotide
Product Code: SOM230B
INN or Proposed INN: pasireotide
Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate
Product Name: pasireotide
Product Code: SOM230B
INN or Proposed INN: pasireotide
Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate
Product Name: pasireotide
Product Code: SOM230B
INN or Proposed INN: pasireotide
Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
146Phase 3Portugal;France;Hungary;Greece;Finland;Spain;Belgium;Denmark;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
16EUCTR2006-004111-22-GR
(EUCTR)
11/12/200730/07/2007A randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing’s diseaseA randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing’s disease Cushing’s disease is rare disease that is caused by an adrenocorticotropic hormone (ACTH) secreting pituitary adenoma. The elevated ACTH secreted by these tumors stimulates the adrenal glands to produce excess cortisol, leading to the subsequent development of the clinical signs and symptoms of hypercortisolism. Cushing's disease is associated with severe morbidity and premature mortality and most commonly affects adults aged 20-50, primarily females
MedDRA version: 8.1;Level: LLT;Classification code 10011651;Term: Cushing's disease
Product Name: pasireotide
Product Code: SOM230B
INN or Proposed INN: pasireotide
Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
146Portugal;France;Hungary;Greece;Finland;Spain;Belgium;Denmark;Germany;United Kingdom;Italy
17EUCTR2006-004111-22-PT
(EUCTR)
09/11/200727/06/2007A randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing’s diseaseA randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing’s disease Cushing’s disease is rare disease that is caused by an adrenocorticotropic hormone (ACTH) secreting pituitary adenoma. The elevated ACTH secreted by these tumors stimulates the adrenal glands to produce excess cortisol, leading to the subsequent development of the clinical signs and symptoms of hypercortisolism. Cushing's disease is associated with severe morbidity and premature mortality and most commonly affects adults aged 20-50, primarily females
MedDRA version: 8.1;Level: LLT;Classification code 10011651;Term: Cushing's disease
Product Name: pasireotide
Product Code: SOM230B
INN or Proposed INN: pasireotide
Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Portugal;Hungary;Greece;Finland;Denmark;Germany;United Kingdom;Italy
18NCT00422201
(ClinicalTrials.gov)
May 15, 200712/1/2007Prospective, Open-Label, Multicenter, International Study of Mifepristone for Symptomatic Treatment of Cushing's Syndrome Caused by Ectopic Adrenal Corticotrophin Hormone (ACTH) SecretionProspective, Open-Label, Multicenter, International Study of Mifepristone for Symptomatic Treatment of Cushing's Syndrome Caused by Ectopic Adrenal Corticotrophin Hormone (ACTH) SecretionCushing's SyndromeDrug: MifepristoneHRA PharmaNULLTerminated18 Years85 YearsAll18Phase 2United States;France;Germany;Italy;Netherlands;United Kingdom
19EUCTR2006-004111-22-FI
(EUCTR)
04/05/200724/01/2007A randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing’s diseaseA randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing’s disease Cushing’s disease is rare disease that is caused by an adrenocorticotropic hormone (ACTH) secreting pituitary adenoma. The elevated ACTH secreted by these tumors stimulates the adrenal glands to produce excess cortisol, leading to the subsequent development of the clinical signs and symptoms of hypercortisolism. Cushing's disease is associated with severe morbidity and premature mortality and most commonly affects adults aged 20-50, primarily females
MedDRA version: 8.1;Level: LLT;Classification code 10011651;Term: Cushing's disease
Product Name: pasireotide
Product Code: SOM230B
INN or Proposed INN: pasireotide
Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Portugal;Hungary;Greece;Finland;Denmark;Germany;United Kingdom;Italy
20EUCTR2006-004080-55-NL
(EUCTR)
26/04/200719/01/2007Stepwise Medical Treatment of Cushing’s Disease: a prospective open label multi-center trial with SOM230 mono- and combination therapy with dopamine agonists and ketoconazole - Stepwise Medical Treatment of Cushing's DiseaseStepwise Medical Treatment of Cushing’s Disease: a prospective open label multi-center trial with SOM230 mono- and combination therapy with dopamine agonists and ketoconazole - Stepwise Medical Treatment of Cushing's Disease The medical condition to be investigated is Cushing's disease which is caused by an ACTH producing pituitary adenoma
MedDRA version: 8.1;Level: LLT;Classification code 10011651;Term: Cushing's disease
Product Name: SOM230
Product Code: SOM230B
INN or Proposed INN: pasireotide
Trade Name: Dostinex
Product Name: Dostinex
INN or Proposed INN: CABERGOLINE
Trade Name: Nizoral
Product Name: Ketoconazole
INN or Proposed INN: KETOCONAZOLE
Erasmus MCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2006-004679-36-DE
(EUCTR)
05/04/200709/10/2006Prospective, open-label, multicenter, international study of mifepristone for symptomatic treatment of Cushing's syndrome caused by ectopic Adrenal Corticotrophin Hormone (ACTH) secretion. - HRA052015 in EASProspective, open-label, multicenter, international study of mifepristone for symptomatic treatment of Cushing's syndrome caused by ectopic Adrenal Corticotrophin Hormone (ACTH) secretion. - HRA052015 in EAS Treatment of Cushing's syndrome caused by ectopic Adrenal Corticotrophin Hormone (ACTH) secretion.
MedDRA version: 14.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders
MedDRA version: 14.0;Classification code 10014146;Term: Ectopic ACTH syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: HRA052015
INN or Proposed INN: mifepristone
Other descriptive name: 17ß-hydroxy-11ß-(4-dimethylaminophenyl)17a-(prop-1-ynyl)estra-4,9-dien-3-one
Laboratoire HRA PharmaNULLNot RecruitingFemale: yes
Male: yes
35France;United States;Netherlands;Germany;Italy
22EUCTR2006-004111-22-DE
(EUCTR)
04/04/200718/04/2007A randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing’s diseaseA randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing’s disease Cushing’s disease is rare disease that is caused by an adrenocorticotropic hormone (ACTH) secreting pituitary adenoma. The elevated ACTH secreted by these tumors stimulates the adrenal glands to produce excess cortisol, leading to the subsequent development of the clinical signs and symptoms of hypercortisolism. Cushing's disease is associated with severe morbidity and premature mortality and most commonly affects adults aged 20-50, primarily females
MedDRA version: 8.1;Level: LLT;Classification code 10011651;Term: Cushing's disease
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Portugal;France;Hungary;Greece;Finland;Spain;Belgium;Denmark;Germany;United Kingdom;Italy
23NCT00612066
(ClinicalTrials.gov)
April 20078/2/2008Rosiglitazone in Treating Patients With Newly Diagnosed ACTH-Secreting Pituitary Tumor (Cushing Disease)An Open Label, Multicenter Study Evaluating the Safety and Efficacy of Short Term (6 Weeks) Rosiglitazone Treatment in Patient's With Cushing's DiseaseCushing's DiseaseDrug: rosiglitazone maleateJonsson Comprehensive Cancer CenterNational Institutes of Health (NIH)Terminated18 Years65 YearsAll2Phase 2United States
24EUCTR2006-004111-22-FR
(EUCTR)
23/03/200712/02/2007A randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing’s diseaseA randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing’s disease Cushing’s disease is rare disease that is caused by an adrenocorticotropic hormone (ACTH) secreting pituitary adenoma. The elevated ACTH secreted by these tumors stimulates the adrenal glands to produce excess cortisol, leading to the subsequent development of the clinical signs and symptoms of hypercortisolism. Cushing's disease is associated with severe morbidity and premature mortality and most commonly affects adults aged 20-50, primarily females
MedDRA version: 8.1;Level: LLT;Classification code 10011651;Term: Cushing's disease
Product Name: pasireotide
Product Code: SOM230B
INN or Proposed INN: pasireotide
Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate
Product Name: pasireotide
Product Code: SOM230B
INN or Proposed INN: pasireotode
Other descriptive name: Cyclo ((diaminoethyl-carbamate)HyPro-Phg-(D) Trp-Ly di-aspartate
Product Name: pasireotide
Product Code: SOM230B
INN or Proposed INN: pasireotide
Other descriptive name: Cyclo ((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Ly di-aspartate
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Portugal;France;Hungary;Greece;Finland;Spain;Belgium;Denmark;Germany;United Kingdom;Italy
25EUCTR2006-004679-36-NL
(EUCTR)
22/03/200731/01/2007Prospective, open-label, multicenter, international study of mifepristone for symptomatic treatment of Cushing's syndrome caused by ectopic Adrenal Corticotrophin Hormone (ACTH) secretion. - HRA052015 in EASProspective, open-label, multicenter, international study of mifepristone for symptomatic treatment of Cushing's syndrome caused by ectopic Adrenal Corticotrophin Hormone (ACTH) secretion. - HRA052015 in EAS Treatment of Cushing's syndrome caused by ectopic Adrenal Corticotrophin Hormone (ACTH) secretion.
MedDRA version: 8.1;Level: LLT;Classification code 10014155;Term: Ectopic corticotrophin syndrome
Product Code: HRA052015
INN or Proposed INN: mifepristone
Other descriptive name: 17ß-hydroxy-11ß-(4-dimethylaminophenyl)17a-(prop-1-ynyl)estra-4,9-dien-3-one
Laboratoire HRA PharmaNULLNot RecruitingFemale: yes
Male: yes
22Germany;Netherlands;France;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2006-004111-22-BE
(EUCTR)
06/03/200714/11/2006A randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing’s diseaseA randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing’s disease Cushing’s disease is rare disease that is caused by an adrenocorticotropic hormone (ACTH) secreting pituitary adenoma. The elevated ACTH secreted by these tumors stimulates the adrenal glands to produce excess cortisol, leading to the subsequent development of the clinical signs and symptoms of hypercortisolism. Cushing's disease is associated with severe morbidity and premature mortality and most commonly affects adults aged 20-50, primarily females
MedDRA version: 14.1;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 10014698 - Endocrine disorders
Product Name: pasireotide
Product Code: SOM230B
INN or Proposed INN: pasireotide
Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate
Product Name: pasireotide
Product Code: SOM230B
INN or Proposed INN: pasireotide
Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
146Phase 3Denmark;Germany;United Kingdom;Italy;Portugal;France;Hungary;Greece;Finland;Spain;Belgium
27EUCTR2006-004111-22-ES
(EUCTR)
05/02/200711/08/2014A randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing?s diseaseA randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing?s disease Cushing?s disease is a rare disease that is caused by an adrenocorticotropic hormone (ACTH) secreting pituitary adenoma. The elevated ACTH secreted by these tumors stimulates the adrenal glands to produce excess cortisol, leading to the subsequent development of the clinical signs and symptoms of hypercortisolism. Cushing?s disease is a rare disease associated with severe morbidity and premature mortality and most commonly affects adults aged 20-50, primarily females.
MedDRA version: 17.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Cancer [C04]
Product Name: pasireotide
Product Code: SOM230B
INN or Proposed INN: pasireotide
Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate
Novartis Farmaceútica S.A.NULLNot RecruitingFemale: yes
Male: yes
162Portugal;United States;Greece;Finland;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Germany;China
28EUCTR2006-004679-36-IT
(EUCTR)
15/01/200730/01/2007Prospective, open-label, multicenter, international study of mifepristone for symptomatic treatment of Cushing s syndrome caused by ectopic Adrenal Corticotrophin Hormone ACTH secretion - HRA052015 in EASProspective, open-label, multicenter, international study of mifepristone for symptomatic treatment of Cushing s syndrome caused by ectopic Adrenal Corticotrophin Hormone ACTH secretion - HRA052015 in EAS Cushing s Syndrome Caused by Ectopic Adrenal Corticotrophin Hormone ACTH Secretion
MedDRA version: 9.1;Level: LLT;Classification code 10014146;Term: Ectopic ACTH syndrome
Product Name: Mifepristone
Product Code: HRA052015
LABORATOIRE HRA PHARMANULLNot RecruitingFemale: yes
Male: yes
22Germany;Netherlands;France;Italy
29EUCTR2006-004111-22-DK
(EUCTR)
05/01/200710/11/2006A randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing’s diseaseA randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing’s disease Cushing’s disease is rare disease that is caused by an adrenocorticotropic hormone (ACTH) secreting pituitary adenoma. The elevated ACTH secreted by these tumors stimulates the adrenal glands to produce excess cortisol, leading to the subsequent development of the clinical signs and symptoms of hypercortisolism. Cushing's disease is associated with severe morbidity and premature mortality and most commonly affects adults aged 20-50, primarily females
MedDRA version: 8.1;Level: LLT;Classification code 10011651;Term: Cushing's disease
Product Name: pasireotide
Product Code: SOM230B
INN or Proposed INN: pasireotide
Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
146Portugal;Hungary;Greece;Finland;Belgium;Denmark;Germany;United Kingdom;Italy
30EUCTR2006-004679-36-FR
(EUCTR)
13/12/200629/09/2006Prospective, open-label, multicenter, international study of mifepristone for symptomatic treatment of Cushing's syndrome caused by ectopic Adrenal Corticotrophin Hormone (ACTH) secretion. - HRA052015 in EASProspective, open-label, multicenter, international study of mifepristone for symptomatic treatment of Cushing's syndrome caused by ectopic Adrenal Corticotrophin Hormone (ACTH) secretion. - HRA052015 in EAS Treatment of Cushing's syndrome caused by ectopic Adrenal Corticotrophin Hormone (ACTH) secretion.
MedDRA version: 8.1;Level: LLT;Classification code 10014155;Term: Ectopic corticotrophin syndrome
Product Code: HRA052015
INN or Proposed INN: mifepristone
Other descriptive name: 17ß-hydroxy-11ß-(4-dimethylaminophenyl)17a-(prop-1-ynyl)estra-4,9-dien-3-one
Laboratoire HRA PharmaNULLNot RecruitingFemale: yes
Male: yes
22France;Netherlands;Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2004-002407-32-GB
(EUCTR)
13/01/200527/06/2005Extension to a multicenter, open label study to assess the safety and efficacy of 600 micrograms SOM230, administered subcutaneously, b.i.d. in patients with Cushing's diseaseExtension to a multicenter, open label study to assess the safety and efficacy of 600 micrograms SOM230, administered subcutaneously, b.i.d. in patients with Cushing's disease Cushing’s disease is an endocrine disease that is caused by an Adrenocorticotropic hormone (ACTH) secreting pituitary adenoma, which is a benign tumor of the pituitary gland. This elevated ACTH stimulates the adrenal glands to produce excess cortisol and subsequent development of the clinical signs and symptoms which include: upper body obesity, severe fatigue and muscle weakness, high blood pressure, backache, elevated blood sugar, and menstrual disorders in womenProduct Code: SOM230B
INN or Proposed INN: Pasireotide
Other descriptive name: Cyclo(diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe)
Novartis Pharmaceuticals UK LtdNULLNot RecruitingFemale: yes
Male: yes
26Italy;United Kingdom
32NCT00001180
(ClinicalTrials.gov)
March 19823/11/1999Dose Response Relationship for Single Doses of Corticotropin Releasing Hormone (CRH) in Normal Volunteers and in Patients With Adrenal InsufficiencyDose Response Relationship for Single Doses of Corticotropin Releasing Hormone (CRH) in Normal Volunteers and in Patients With Adrenal InsufficiencyAdrenal Gland Hyperfunction;Adrenal Gland Hypofunction;Cushing's Syndrome;HealthyDrug: Ovine Corticotropin-Releasing Hormone (oCRH)Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NULLCompletedN/AN/ABoth2250N/AUnited States