Cabergoline ( DrugBank: Cabergoline )


3 diseases
告示番号疾患名(ページ内リンク)臨床試験数
6パーキンソン病12
74下垂体性PRL分泌亢進症4
75クッシング病16

6. パーキンソン病


臨床試験数 : 2,307 薬物数 : 2,007 - (DrugBank : 349) / 標的遺伝子数 : 188 - 標的パスウェイ数 : 199
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01270711
(ClinicalTrials.gov)
November 20109/12/2010Study On Utilization Of Cabergoline For Compliance With Risk Minimization Activities (SUCRE)Study on Utilization Of Cabergoline For Compliance With Risk Minimization Activities (SUCRE)Parkinson's Disease;HyperprolactinemiaDrug: Study DrugPfizerNULLCompletedN/AN/AAll22014N/ANULL
2EUCTR2005-001006-12-CZ
(EUCTR)
06/09/200624/08/2006Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSODouble-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSO Patients with advanced Parkinson’s disease with motor fluctuations and OFF” periods refractory to conventional treatment.
MedDRA version: 9.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated
Product Name: Lisparin
INN or Proposed INN: Lisuride Hydrogenmaleate
Other descriptive name: 3- (9,10- Didehydro- 6- methyl- 8?- ergolinyl)-1,1- diethylurea hydrogenmaleate
Product Name: Pramipexol
INN or Proposed INN: Pramipexol
Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol
Product Name: Pramipexol
INN or Proposed INN: Pramipexol
Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol
Product Name: Cabergoline
INN or Proposed INN: Cabergoline
Other descriptive name: 1[(6- Allyl- 8ß- ergolinyl)carbonyl]- 1- [3- (dimethylamino)propyl]- 3- ethylurea
Product Name: Cabergoline
INN or Proposed INN: Cabergoline
Other descriptive name: 1[(6- Allyl- 8ß- erg
Axxonis Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
60Phase 2;Phase 3Czech Republic;Austria;Germany;Italy
3EUCTR2005-001006-12-AT
(EUCTR)
02/04/200628/02/2006Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSODouble-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSO Patients with advanced Parkinson’s disease with motor fluctuations and OFF” periods refractory to conventional treatment.Product Name: Lisparin
INN or Proposed INN: Lisuride Hydrogenmaleate
Other descriptive name: 3- (9,10- Didehydro- 6- methyl- 8?- ergolinyl)-1,1- diethylurea hydrogenmaleate
Trade Name: Sifrol, 0,35 mg Tablette
Product Name: Pramipexol
INN or Proposed INN: Pramipexol
Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol
Trade Name: Sifrol, 0,70 mg Tablette
Product Name: Pramipexol
INN or Proposed INN: Pramipexol
Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol
Trade Name: Cabaseril, 1,0 mg Tablette
Product Name: Cabergoline
INN or Proposed INN: Cabergoline
Other descriptive name: 1[(6- Allyl- 8ß- ergolinyl)carbonyl]- 1- [3- (dimethylamino)propyl]- 3- ethylurea
Trade Name: Cabaseril, 2,0 mg Tablette
Product Name: Cabergoline
INN or Proposed INN: Cabergoline
Other descriptive name: 1[(6- Allyl- 8ß- ergolinyl)carbonyl]- 1- [3- (dimethylamino)propyl]-
Axxonis Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Germany;Czech Republic;Italy;Austria
4EUCTR2005-001006-12-DE
(EUCTR)
09/03/200605/09/2006Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSODouble-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSO Patients with advanced Parkinson’s disease with motor fluctuations and OFF” periods refractory to conventional treatment.
MedDRA version: 9.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated
Product Name: Lisparin
INN or Proposed INN: Lisuride Hydrogenmaleate
Other descriptive name: 3- (9,10- Didehydro- 6- methyl- 8?- ergolinyl)-1,1- diethylurea hydrogenmaleate
Product Name: Pramipexol
INN or Proposed INN: Pramipexol
Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol
Product Name: Pramipexol
INN or Proposed INN: Pramipexol
Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol
Product Name: Cabergoline
INN or Proposed INN: Cabergoline
Other descriptive name: 1[(6- Allyl- 8ß- ergolinyl)carbonyl]- 1- [3- (dimethylamino)propyl]- 3- ethylurea
Product Name: Cabergoline
INN or Proposed INN: Cabergoline
Other descriptive name: 1[(6- Allyl- 8ß- erg
Axxonis Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
60Phase 2;Phase 3Czech Republic;Austria;Germany;Italy
5EUCTR2004-001485-41-GB
(EUCTR)
26/07/200521/06/2005A single-blinded assessment of the short-term effects of cabergoline vs. carbidopa/levodopa on SPECT dopamine transporter density in out-patient subjects with Parkinson’s Disease - N/AA single-blinded assessment of the short-term effects of cabergoline vs. carbidopa/levodopa on SPECT dopamine transporter density in out-patient subjects with Parkinson’s Disease - N/A Approximately 120 recently diagnosed/early Parkinson’s disease subjects, who are untreated (see exclusionary criteria).Trade Name: Sinemet
Product Name: Sinemet
INN or Proposed INN: carbidopa/levodopa
Trade Name: Cabaser
Product Name: Cabaseril
INN or Proposed INN: Cabergoline
Trade Name: DaTSCAN
Product Name: DatSCAN
INN or Proposed INN: Ioflupane [123 I]
Institute for Neurodegenerative DisordersNULLNot RecruitingFemale: yes
Male: yes
120United Kingdom;Spain
6EUCTR2004-001485-41-ES
(EUCTR)
28/04/200530/01/2006A single-blinded assessment of the short-term effects of cabergoline vs. carbidopa/levodopa on SPECT dopamine transporter density in out-patient subjects with Parkinson’s DiseaseA single-blinded assessment of the short-term effects of cabergoline vs. carbidopa/levodopa on SPECT dopamine transporter density in out-patient subjects with Parkinson’s Disease Approximately 120 recently diagnosed/early Parkinson’s disease subjects, who are untreated (see exclusionary criteria).Trade Name: SINEMET
Product Name: carbodopa/levadopa
INN or Proposed INN: CARBODOPA LEVADOPA
Trade Name: SOLIGEN
Product Name: Cabergoline
INN or Proposed INN: CABERGOLINA
Trade Name: DaTSCAN
INN or Proposed INN: Ioflupane [123I]
Institute for Neurodegenerative DisordersNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120United Kingdom;Spain
7EUCTR2004-001485-41-AT
(EUCTR)
20/04/200516/03/2005A single-blinded assessment of the short-term effects of cabergoline vs. carbidopa/levodopa on SPECT dopamine transporter density in out-patient subjects with Parkinson’s Disease - N/AA single-blinded assessment of the short-term effects of cabergoline vs. carbidopa/levodopa on SPECT dopamine transporter density in out-patient subjects with Parkinson’s Disease - N/A Approximately 120 recently diagnosed/early Parkinson’s disease subjects, who are untreated (see exclusionary criteria).Trade Name: Sinemet
Product Name: Sinemet
INN or Proposed INN: carbidopa/levodopa
Trade Name: Cabaseril
Product Name: Cabaseril
INN or Proposed INN: Cabergoline
Trade Name: DaTSCAN
Product Name: DatSCAN
INN or Proposed INN: Ioflupane [123 I]
Institute for Neurodegenerative DisordersNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Spain;Austria;United Kingdom
8EUCTR2004-002650-59-GB
(EUCTR)
03/02/200530/06/2005A phase 3b, open-label, multicentre, multinational trial to assess the tolerability of switching subjects from ropinerole, pramipexole or cabergoline to the rotigotine transdermal system and its effect on symptoms with idiopathic Parkinson's disease - n/aA phase 3b, open-label, multicentre, multinational trial to assess the tolerability of switching subjects from ropinerole, pramipexole or cabergoline to the rotigotine transdermal system and its effect on symptoms with idiopathic Parkinson's disease - n/a Idiopathic Parkinson's diseaseProduct Name: rotigotine
Product Code: SPM 962
INN or Proposed INN: rotigotine
SCHWARZ BIOSCIENCESNULLNot RecruitingFemale: yes
Male: yes
130Phase 3United Kingdom
9NCT00153972
(ClinicalTrials.gov)
February 20057/9/2005Dopamine Turnover Rate as Surrogate Parameter for Diagnosis of Early Parkinson's DiseaseDopamine Turnover Rate Measured With F-Dopa-PET as Surrogate Parameter for Diagnosis and Progression Analysis of Early Parkinson's DiseaseParkinson's DiseaseDrug: Cabergoline;Drug: LevodopaTechnische Universität DresdenPfizerCompleted40 Years85 YearsBoth39Phase 4Germany
10NCT00129181
(ClinicalTrials.gov)
January 20059/8/2005Study of the Effects of Dopaminergic Medications on Dopamine Transporter Density in Subjects With Parkinson's DiseaseA Single-blinded Assessment of the Short-term Effects of Cabergoline vs. Carbidopa/Levodopa on SPECT Dopamine Transporter Density in Out-patient Subjects With Parkinson's DiseaseParkinson Disease;Parkinsonian SyndromeDrug: cabergoline;Drug: carbidopa/levodopa;Procedure: DATscan and SPECT imagingInstitute for Neurodegenerative DisordersPfizer;GE HealthcareCompleted40 YearsN/ABoth30N/AAustria;Germany;Italy;Spain;United Kingdom
11NCT00242008
(ClinicalTrials.gov)
December 200418/10/2005A Trial To Assess Switching From Ropinirole, Pramipexole Or Cabergoline To The Rotigotine Transdermal System In Idiopathic Parkinson's DiseaseA Phase 3b, Open-Label, Multicenter, Multinational Trial To Assess The Tolerability Of Switching Subjects From Ropinirole, Pramipexole Or Cabergoline To The Rotigotine Transdermal System And Its Effect On Symptoms In Subjects With Idiopathic Parkinson's DiseaseParkinson's DiseaseDrug: RotigotineUCB PharmaNULLCompleted18 YearsN/ABothPhase 3United States
12NCT00174239
(ClinicalTrials.gov)
July 20049/9/2005Study Of Cabaser and Sinemet CR For The Treatment Of Nighttime Symptoms Associated With Parkinson's Disease.A Double-Blind, Randomized, Comparative Study of Cabaser and Sinemet CR For The Treatment Of Nocturnal Disability In Levodopa -Treated Parkinson's Disease Patients.Parkinson DiseaseDrug: cabergoline;Drug: controlled-release levodopa / carbidopaPfizerNULLTerminated18 Years80 YearsBoth220Phase 4Australia;Italy;Spain;United Kingdom

74. 下垂体性PRL分泌亢進症


臨床試験数 : 19 薬物数 : 28 - (DrugBank : 10) / 標的遺伝子数 : 14 - 標的パスウェイ数 : 65
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03400865
(ClinicalTrials.gov)
October 25, 20188/1/2018Cabergoline Combined Hydroxychloroquine/Chloroquine to Treat Resistant ProlactinomasThe Effect of Combined Treatment of Cabergoline With Hydroxychloroquine/Chloroquine for Resistant ProlactinomasResistance, Disease;ProlactinomaDrug: HCQ/CQ and CAB combined treatmentZhebao WuXinqiao Hospital of Chongqing;First Hospital of China Medical University;Beijing Tiantan Hospital;First Affiliated Hospital of Wenzhou Medical University;First Affiliated Hospital of Fujian Medical University;Peking Union Medical College Hospital;Huashan Hospital;Chinese PLA General HospitalNot yet recruiting18 Years70 YearsAll30N/AChina
2NCT03457389
(ClinicalTrials.gov)
February 22, 201823/1/2018Comparison of Treatment Outcome of Cabergoline According to Target Prolactin Levels in Patients With ProlactinomaComparison of Treatment Outcome of Cabergoline According to Target Prolactin Levels in Patients With Prolactinoma: A Prospective, Randomized, Open Label, Active-controlled, Clinical TrialPituitary Adenoma;Prolactinoma;Pituitary Tumor;Recurrence TumorDrug: CabergolineSeoul National University HospitalNULLRecruiting19 YearsN/AAll68N/AKorea, Republic of
3NCT01620138
(ClinicalTrials.gov)
March 201018/9/2011Response to Cabergoline and Pasireotide in Non-functioning Pituitary Adenomas and Resistant ProlactinomasSomatostatin and Dopamine Receptors Expression in Non-functioning Pituitary Adenomas and Resistant Prolactinomas: Correlation With in Vitro and in Vivo Responsiveness to Somatostatin Analogs and Dopamine AgonistNon-functioning Pituitary Adenomas;ProlactinomasDrug: Pasireotide;Drug: cabergolineUniversidade Federal do Rio de JaneiroNULLCompleted18 YearsN/AAll21Phase 2/Phase 3Brazil
4NCT00460616
(ClinicalTrials.gov)
January 200713/4/2007Cardiac Valve Complications in Prolactinomas Treated With CabergolineObservational Study to Investigate the Prevalence of Cardiac Abnormalities and Valvular Regurgitation in Patients With Prolactinomas Treated Chronically With CabergolineProlactinomasDrug: CabergolineFederico II UniversityNULLCompleted18 Years65 YearsBoth50Italy

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
1EUCTR2019-004019-29-IT
(EUCTR)
15/07/202107/10/2020Italian study to evaluate the efficacy of retinoic acid and cabergoline therapy in combination in Cushing's disease.Medical combination therapy with retinoic acid and cabergoline in ACTH-secreting pituitary adenoma: a prospective and randomized study. - CRACCA Cushing's disease in patients in whom pituitary surgery has not been curative or in situations where it is contraindicated or refused by patient.
MedDRA version: 20.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Dostinex
Product Name: Cabergolina
Product Code: [G02CB03]
INN or Proposed INN: CABERGOLINA
Other descriptive name: NON COMMERCIAL
Trade Name: VESANOID
Product Name: Tretinoina
Product Code: [L01XX14]
INN or Proposed INN: TRETINOINA
Other descriptive name: NON COMMERCIAL
Dipartimento di Medicina-DIMED, università di PadovaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Italy
2EUCTR2013-002170-49-NL
(EUCTR)
25/03/201517/12/2014A Phase II trial to assess the efficacy and safety of pasireotide s.c. alone or in combination with cabergoline in patients with Cushing’s diseaseA Phase II trial to assess the efficacy and safety of pasireotide s.c. alone or in combination with cabergoline in patients with Cushing’s disease Cushing's disease
MedDRA version: 18.1;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860 ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Dostinex
Product Name: Cabergoline
INN or Proposed INN: cabergoline
Other descriptive name: CABERGOLINE
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
64 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Venezuela, Bolivarian Republic of;Greece;Spain;Turkey;Colombia;Italy;United Kingdom;India;France;Hungary;Mexico;Argentina;Malaysia;Belgium;Brazil;Australia;Bulgaria;Germany;Netherlands
3EUCTR2013-002170-49-BE
(EUCTR)
19/03/201404/12/2013 A Phase II trial to assess the efficacy and safety of pasireotide s.c. alone or in combination with cabergoline in patients with Cushing's disease A Phase II trial to assess the efficacy and safety of pasireotide s.c. alone or in combination with cabergoline in patients with Cushing’s disease Cushing's disease
MedDRA version: 19.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860
Trade Name: Signifor
Product Name: pasireotide 0.3mg
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Signifor
Product Name: pasireotide 0.6mg
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Signifor
Product Name: pasireotide 0.9 mg
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Dostinex
Product Name: Cabergoline
Other descriptive name: CABERGOLINE
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
64 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Venezuela, Bolivarian Republic of;Greece;Spain;Turkey;Colombia;Italy;United Kingdom;India;France;Hungary;Mexico;Argentina;Malaysia;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany
4NCT01915303
(ClinicalTrials.gov)
March 6, 201410/6/2013Study of the Efficacy and Safety of Pasireotide s.c. +/- Cabergoline in Patients With Cushing's DiseaseA Phase II Trial to Assess the Efficacy and Safety of Pasireotide s.c. Alone or in Combination With Cabergoline in Patients With Cushing's DiseaseCushings DiseaseDrug: Pasireotide with or without cabergolineNovartis PharmaceuticalsNULLTerminated18 YearsN/AAll68Phase 2United States;Argentina;Belgium;Brazil;Colombia;France;Germany;Greece;Hungary;India;Italy;Malaysia;Mexico;Netherlands;Spain;Turkey;Australia;Bulgaria;Venezuela
5EUCTR2013-002170-49-HU
(EUCTR)
03/02/201413/12/2013A Phase II trial to assess the efficacy and safety of pasireotide s.c. alone or in combination with cabergoline in patients with Cushing’s diseaseA Phase II trial to assess the efficacy and safety of pasireotide s.c. alone or in combination with cabergoline in patients with Cushing’s disease Cushing's disease
MedDRA version: 18.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Dostinex
Product Name: Cabergoline
Other descriptive name: CABERGOLINE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
64Phase 2United States;Venezuela, Bolivarian Republic of;Greece;Spain;Turkey;Colombia;Italy;India;France;Hungary;Mexico;Argentina;Malaysia;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany
6EUCTR2013-002170-49-GR
(EUCTR)
29/01/201424/01/2014A Phase II trial to assess the efficacy and safety ofpasireotide s.c. alone or in combination with cabergoline inpatients with Cushing’s diseaseA Phase II trial to assess the efficacy and safety ofpasireotide s.c. alone or in combination with cabergoline inpatients with Cushing’s disease Cushing's diseaseProduct Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Dostinex
Product Name: Cabergoline
Other descriptive name: CABERGOLINE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
128Phase 2United States;Venezuela, Bolivarian Republic of;Greece;Spain;Turkey;Colombia;United Kingdom;Italy;India;France;Hungary;Mexico;Argentina;Malaysia;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany
7EUCTR2013-002170-49-IT
(EUCTR)
21/01/201422/10/2013Study of the efficacy and safety of pasireotide s.c. +/- cabergoline in patients with Cushing’s diseaseA Phase II trial to assess the efficacy and safety ofpasireotide s.c. alone or in combination with cabergoline inpatients with Cushing’s disease Cushing's disease
MedDRA version: 14.1;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Other descriptive name: NA
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Other descriptive name: NA
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Other descriptive name: NA
Trade Name: Dostinex
Product Name: Cabergoline
Product Code: NA
INN or Proposed INN: cabergoline
Other descriptive name: NA
NOVARTIS FARMA S.p.A.NULLNot RecruitingFemale: yes
Male: yes
128Phase 2United States;Venezuela, Bolivarian Republic of;Greece;Spain;Turkey;Colombia;United Kingdom;Italy;India;France;Hungary;Mexico;Argentina;Belgium;Brazil;Malaysia;Australia;Bulgaria;Netherlands;Germany
8EUCTR2013-002170-49-FR
(EUCTR)
27/12/201303/12/2015A Phase II trial to assess the efficacy and safety ofpasireotide s.c. alone or in combination with cabergoline inpatients with Cushing’s diseaseA Phase II trial to assess the efficacy and safety ofpasireotide s.c. alone or in combination with cabergoline inpatients with Cushing’s disease Cushing's diseaseProduct Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: CABERGOLINE TEVA
Product Name: Cabergoline
Other descriptive name: CABERGOLINE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
128Phase 2United States;Venezuela, Bolivarian Republic of;Greece;Spain;Turkey;Colombia;Italy;United Kingdom;India;France;Hungary;Mexico;Argentina;Malaysia;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany
9EUCTR2013-002170-49-ES
(EUCTR)
21/11/201312/11/2013A Phase II trial to assess the efficacy and safety ofpasireotide s.c. alone or in combination with cabergoline in patients with Cushing?s diseaseA Phase II trial to assess the efficacy and safety ofpasireotide s.c. alone or in combination with cabergoline in patients with Cushing?s disease Cushing's disease;Therapeutic area: Diseases [C] - Cancer [C04]Trade Name: SIGNIFOR
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Other descriptive name: PASIREOTIDE DIASPARTATE
Trade Name: SIGNIFOR
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Other descriptive name: PASIREOTIDE DIASPARTATE
Trade Name: SIGNIFOR
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Other descriptive name: PASIREOTIDE DIASPARTATE
Trade Name: Dostinex
Product Name: Cabergoline
INN or Proposed INN: CABERGOLINE
Other descriptive name: CABERGOLINE
Novartis Farmacéutica , S.A.NULLNot RecruitingFemale: yes
Male: yes
128Phase 2United States;Venezuela, Bolivarian Republic of;Greece;Spain;Turkey;Colombia;United Kingdom;Italy;India;France;Hungary;Mexico;Argentina;Malaysia;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany
10EUCTR2013-002170-49-DE
(EUCTR)
19/11/201317/09/2013A Phase II trial to assess the efficacy and safety of pasireotide s.c. alone or in combination with cabergoline in patients with Cushing's diseaseA Phase II trial to assess the efficacy and safety of pasireotide s.c. alone or in combination with cabergoline in patients with Cushing's disease Cushing's disease
MedDRA version: 19.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Dostinex
Product Name: Cabergoline
Other descriptive name: CABERGOLINE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
64Phase 2United States;Venezuela, Bolivarian Republic of;Greece;Spain;Turkey;Colombia;Italy;India;France;Hungary;Mexico;Argentina;Belgium;Brazil;Malaysia;Australia;Bulgaria;Netherlands;Germany
11NCT01794793
(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 4Argentina;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;United States;China
12EUCTR2011-003264-77-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
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
14NCT00889525
(ClinicalTrials.gov)
November 200727/4/2009Study of Cabergoline in Treatment of Corticotroph Pituitary TumorStudy of Cabergoline in Treatment of Corticotroph Pituitary TumorCushing's Disease;Corticotroph AdenomaDrug: CabergolineSeth Gordhandas Sunderdas Medical CollegeNULLCompleted12 YearsN/ABothPhase 3India
15EUCTR2006-004080-55-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
16EUCTR2006-005218-11-IT
(EUCTR)
15/09/200603/04/2007EFFECTIVENESS AND TOLERABILITY OF TREATMENT WITH CABERGOLINE IN PATIENTS WITH CUSHING S SYNDROME - CABERGOLINE IN CUSHING S SYNDROMEEFFECTIVENESS AND TOLERABILITY OF TREATMENT WITH CABERGOLINE IN PATIENTS WITH CUSHING S SYNDROME - CABERGOLINE IN CUSHING S SYNDROME Cushing syndrome
MedDRA version: 9.1;Level: LLT;Classification code 10011652;Term: Cushing's syndrome
Trade Name: DOSTINEX
Trade Name: NIZORAL
ASSOCIAZIONE ITALIANA ENDOCRINOLOGIA-METABOLISMO-IPOFISINULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy