ROSUVASTATIN CALCIUM ( DrugBank: Rosuvastatin, Calcium )


4 diseases
告示番号疾患名(ページ内リンク)臨床試験数
49全身性エリテマトーデス1
79家族性高コレステロール血症(ホモ接合体)3
97潰瘍性大腸炎1
299嚢胞性線維症1

49. 全身性エリテマトーデス


臨床試験数 : 946 薬物数 : 733 - (DrugBank : 186) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 198
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2006-006214-16-GB
(EUCTR)
23/02/201029/02/2008A randomised placebo controlled trial of rosuvastatin in systemic lupus erythematosus. - RCT of statin in SLEA randomised placebo controlled trial of rosuvastatin in systemic lupus erythematosus. - RCT of statin in SLE Systemic lupus erythematosus.
MedDRA version: 13.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: Crestor
Product Name: Crestor
INN or Proposed INN: ROSUVASTATIN CALCIUM
Other descriptive name: rosuvastatin
Trade Name: Crestor
Product Name: Crestor
INN or Proposed INN: ROSUVASTATIN CALCIUM
Other descriptive name: rosuvastatin
Imperial CollegeNULLNot Recruiting Female: yes
Male: yes
64 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom

79. 家族性高コレステロール血症(ホモ接合体)


臨床試験数 : 142 薬物数 : 119 - (DrugBank : 29) / 標的遺伝子数 : 9 - 標的パスウェイ数 : 18
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2014-004746-99-DK
(EUCTR)
27/03/201527/03/2015A study to evluate the safety of Rosuvastatin in Children and Adolescents with Homozygous Familial Hypercholesterolemia.An Open-Label Long-Term Extension to the Randomized, Double-blind, Placebo-controlled, Multi-center, Cross-over Study of Rosuvastatin in Children and Adolescents (aged 6 to <18 years) with Homozygous Familial Hypercholesterolemia (HoFH) Hypercholesterolemia - The current trial will study children with Homozygous Familial Hypercholesterolemia (HoFH).
MedDRA version: 19.0;Level: LLT;Classification code 10054380;Term: Familial hypercholesterolemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Crestor Film-Coated Tablet
Product Name: Crestor
Product Code: ZD4522
INN or Proposed INN: Rosuvastatin calcium
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
20Phase 3United States;Taiwan;Canada;Malaysia;Belgium;Lebanon;Denmark;Israel;Netherlands;Germany;Sweden
2EUCTR2014-004746-99-BE
(EUCTR)
23/02/201518/12/2014A study to evluate the safety of Rosuvastatin in Children and Adolescents with Homozygous Familial Hypercholesterolemia.An Open-Label Long-Term Extension to the Randomized, Double-blind, Placebo-controlled, Multi-center, Cross-over Study of Rosuvastatin in Children and Adolescents (aged 6 to <18 years) with Homozygous Familial Hypercholesterolemia (HoFH) Hypercholesterolemia - The current trial will study children with Homozygous Familial Hypercholesterolemia (HoFH).;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]Trade Name: Crestor Film-Coated Tablet
Product Name: Crestor
Product Code: ZD4522
INN or Proposed INN: Rosuvastatin calcium
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
20Phase 3United States;Taiwan;Canada;Malaysia;Belgium;Lebanon;Denmark;Israel;Netherlands;Germany;Sweden
3EUCTR2014-004746-99-SE
(EUCTR)
23/12/2014A study to evluate the safety of Rosuvastatin in Children and Adolescents with Homozygous Familial Hypercholesterolemia.An Open-Label Long-Term Extension to the Randomized, Double-blind, Placebo-controlled, Multi-center, Cross-over Study of Rosuvastatin in Children and Adolescents (aged 6 to <18 years) with Homozygous Familial Hypercholesterolemia (HoFH) Hypercholesterolemia - The current trial will study children with Homozygous Familial Hypercholesterolemia (HoFH).;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]Trade Name: Crestor Film-Coated Tablet
Product Name: Crestor
Product Code: ZD4522
INN or Proposed INN: Rosuvastatin calcium
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
20Phase 3United States;Taiwan;Canada;Malaysia;Belgium;Lebanon;Denmark;Israel;Netherlands;Germany;Sweden

97. 潰瘍性大腸炎


臨床試験数 : 2,527 薬物数 : 1,503 - (DrugBank : 259) / 標的遺伝子数 : 143 - 標的パスウェイ数 : 201
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-004208-37-BE
(EUCTR)
03/08/202004/03/2020Statins for treating ulcerative colitis through GI microbiomeDrug repurposing - Statins as microbiota modulating agents in ulcerative colitis - ReMiDy There are two population groups, 20 healthy volunteers and at least 150 individuals diagnosed with mild/moderate active ulcerative colitis or are in remission.;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Rosuvastatine EG
Product Name: rosuvastatin
INN or Proposed INN: rosuvastatin
Other descriptive name: ROSUVASTATIN CALCIUM
UZ LeuvenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 3Belgium

299. 嚢胞性線維症


臨床試験数 : 1,696 薬物数 : 1,658 - (DrugBank : 272) / 標的遺伝子数 : 96 - 標的パスウェイ数 : 170
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2014-002387-32-GB
(EUCTR)
05/08/201427/06/2014Trial of Rosuvastatin for the Prevention of Kidney Toxicity caused by Tobramycin in Children with Cystic FibrosisPhase IIa, Randomised, Controlled, Open-Label Trial of Rosuvastatin for the Prevention of Aminoglycoside-Induced Kidney Toxicity in Children with Cystic Fibrosis - PROteKT Aminoglycoside-induced nephrotoxicity
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 18.0;Classification code 10069022;Term: Kidney injury molecule-1;System Organ Class: 10022891 - Investigations
MedDRA version: 18.0;Level: LLT;Classification code 10067571;Term: Nephrotoxicity;System Organ Class: 100000004857;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
Trade Name: Crestor
Product Name: Crestor
INN or Proposed INN: Rosuvastatin calcium
University of LiverpoolNULLNot RecruitingFemale: yes
Male: yes
50Phase 2United Kingdom