ACLASTA ( DrugBank: - )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
13多発性硬化症/視神経脊髄炎3
274骨形成不全症2

13. 多発性硬化症/視神経脊髄炎


臨床試験数 : 3,342 薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 266 - 標的パスウェイ数 : 240
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01166178
(ClinicalTrials.gov)
October 201019/7/2010Zoledronic Acid in MS-patients With OsteoporosisA 1-year, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Zoledronic Acid 5 mg (Aclasta®) on Bone Mineral Density in Patients With Multiple Sclerosis Followed by a 1-year Open-label Treatment PhaseOsteoporosis;Multiple SclerosisDrug: Zoledronic Acid;Drug: Placebo;Dietary Supplement: Calcium and Vitamin D combinationNovartisNULLTerminated18 Years75 YearsAll29Phase 3Germany
2EUCTR2009-011888-37-DE
(EUCTR)
23/07/201026/03/2010A 1-year, multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the efficacy of zoledronic acid 5 mg (Aclasta®) on bone mineral density in patients with multiple sclerosis followed by a 1-year open-label treatment phase - EXALTA 1-year, multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the efficacy of zoledronic acid 5 mg (Aclasta®) on bone mineral density in patients with multiple sclerosis followed by a 1-year open-label treatment phase - EXALT osteoporosis in patients with multiple sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10049088;Term: Osteopenia;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.1;Classification code 10031282;Term: Osteoporosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: Aclasta 5 mg Infusionslösung
Product Name: Aclasta
Product Code: ZOL446H
Other descriptive name: ZOLEDRONIC ACID MONOHYDRATE
Novartis Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
Germany
3EUCTR2008-005304-93-GB
(EUCTR)
13/02/200912/12/2008A Randomised Control Trial To Evaluate Whether Zoledronate Prevents Bone Loss In Acute Exacerbations Of Multiple Sclerosis - Zoledronate in multiple sclerosisA Randomised Control Trial To Evaluate Whether Zoledronate Prevents Bone Loss In Acute Exacerbations Of Multiple Sclerosis - Zoledronate in multiple sclerosis Bone loss in patients with Multiple Sclerosis (MS) who require large short term doses of methylprednisolone for exacerbations of their disease.
MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse
MedDRA version: 9.1;Classification code 10065687;Term: Bone loss
Trade Name: Aclasta 5mg solution for infusion
Product Name: Aclasta
Product Code: ZOL446H
North Bristol TrustNULLNot RecruitingFemale: yes
Male: yes
United Kingdom

274. 骨形成不全症


臨床試験数 : 87 薬物数 : 103 - (DrugBank : 20) / 標的遺伝子数 : 14 - 標的パスウェイ数 : 76
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2011-000745-21-BE
(EUCTR)
10/12/201218/09/2012An international, multicenter, efficacy and safety trial of intravenous zoledronic acid in infants less than one year of age, with severe osteogenesis imperfectaAn international, multicenter, open-label, efficacy and safety trial of intravenous zoledronic acid in infants less than one year of age, with severe osteogenesis imperfecta - SHC - INFOI Children suffering from severe Osteogenesis Imperfecta
MedDRA version: 14.1;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: ACLASTA
Product Name: zoledronic acid
INN or Proposed INN: RITUXIMAB
Schriners Hospitals for ChildrenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
15United States;Canada;Belgium
2EUCTR2011-002811-27-DK
(EUCTR)
07/11/201104/11/2011The Effect of Treatment with PTH and Zoledronic acid in Patients with Osteogenesis ImperfectaThe Effect of Treatment with PTH and Zoledronic acid in Patients with Osteogenesis Imperfecta - OI-treatment Osteogenesis imperfecta;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Trade Name: Forsteo
Product Code: H05AA02
Trade Name: Aclasta
Bente Langdahl, consultant, ass. professor, PhD, DMScNULLNot RecruitingFemale: yes
Male: yes
80Phase 2Denmark