78. 下垂体前葉機能低下症 Hypopituitarism Clinical trials / Disease details


臨床試験数 : 492 薬物数 : 341 - (DrugBank : 47) / 標的遺伝子数 : 45 - 標的パスウェイ数 : 100

  
5 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2013-002892-16-LV
(EUCTR)
12/10/201531/07/2015A trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiencyA multicentre, multinational, randomised, parallel-group, placebo-controlled (double blind) and active-controlled (open) trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency for 35 weeks, followed by a 53-week open-label extension period - REAL 1 Growth hormone deficiency in adults
MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: NNC0195-0092 PDS290 10 mg-1.5 ml
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Trade Name: Norditropin FlexPro 10 mg
INN or Proposed INN: Somatropin
Novo Nordisk A/SNULLNot Recruiting Female: yes
Male: yes
280 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Ukraine;Lithuania;Turkey;Russian Federation;United Kingdom;India;European Union;Brazil;Malaysia;Australia;South Africa;Germany;Latvia;Japan;Sweden
2EUCTR2013-002892-16-LT
(EUCTR)
30/09/201527/07/2015A trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiencyA multicentre, multinational, randomised, parallel-group, placebo-controlled (double blind) and active-controlled (open) trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency for 35 weeks, followed by a 53-week open-label extension period - REAL 1 Growth hormone deficiency in adults
MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: NNC0195-0092 PDS290 10 mg-1.5 ml
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Trade Name: Norditropin FlexPro 10 mg
INN or Proposed INN: Somatropin
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
280Phase 3United States;Ukraine;Lithuania;Turkey;Russian Federation;India;European Union;Brazil;Malaysia;Australia;South Africa;Latvia;Germany;Japan;Sweden
3EUCTR2013-002892-16-DE
(EUCTR)
22/12/201429/09/2014A trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiencyA multicentre, multinational, randomised, parallel-group, placebo-controlled (double blind) and active-controlled (open) trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency for 35 weeks, followed by a 53-week open-label extension period - REAL 1 Growth hormone deficiency in adults
MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: NNC0195-0092 PDS290 10 mg-1.5 ml
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Trade Name: Norditropin FlexPro 10 mg
INN or Proposed INN: Somatropin
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
280Phase 3United States;Ukraine;Lithuania;Turkey;Russian Federation;India;European Union;Brazil;Malaysia;Australia;South Africa;Latvia;Germany;Japan;Sweden
4EUCTR2013-002892-16-GB
(EUCTR)
20/11/201424/09/2014A trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiencyA multicentre, multinational, randomised, parallel-group, placebo-controlled (double blind) and active-controlled (open) trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency for 35 weeks, followed by a 53-week open-label extension period - REAL 1 Growth hormone deficiency in adults
MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: NNC0195-0092 PDS290 10 mg-1.5 ml
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Trade Name: Norditropin FlexPro 10 mg
INN or Proposed INN: Somatropin
Novo Nordisk A/SNULLNot Recruiting Female: yes
Male: yes
280 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Ukraine;Lithuania;Turkey;Russian Federation;United Kingdom;India;European Union;Brazil;Malaysia;Australia;South Africa;Latvia;Germany;Japan;Sweden
5EUCTR2013-002892-16-SE
(EUCTR)
07/10/201403/09/2014A trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiencyA multicentre, multinational, randomised, parallel-group, placebo-controlled (double blind) and active-controlled (open) trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency for 35 weeks, followed by a 53-week open-label extension period - REAL 1 Growth hormone deficiency in adults
MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: NNC0195-0092 PDS290 10 mg-1.5 ml
INN or Proposed INN: N/A
Other descriptive name: NNC0195-0092
Trade Name: Norditropin FlexPro 10 mg
INN or Proposed INN: Somatropin
Novo Nordisk A/SNULLNot RecruitingFemale: yes
Male: yes
280Phase 3United States;Ukraine;Lithuania;Turkey;Russian Federation;India;European Union;Brazil;Malaysia;Australia;South Africa;Latvia;Germany;Japan;Sweden