113. 筋ジストロフィー Muscular dystrophy Clinical trials / Disease details
臨床試験数 : 646 / 薬物数 : 471 - (DrugBank : 105) / 標的遺伝子数 : 59 - 標的パスウェイ数 : 170
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2011-001266-17-CZ (EUCTR) | 20/12/2012 | 30/10/2012 | An open-label extension study of the long-term safety,tolerability and efficacy of GSK2402968 in subjects with Duchenne Muscular Dystrophy | An open-label extension study of the long-term safety,tolerability and efficacy of GSK2402968 in subjects withDuchenne Muscular Dystrophy - N/A | Duchenne Muscular Dystrophy MedDRA version: 14.1;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: GSK2402968 Product Code: GSK2402968 INN or Proposed INN: GSK2402968 | GlaxoSmithKline Research and Development LTD | NULL | Not Recruiting | Female: no Male: yes | 200 | Taiwan;Spain;Turkey;Israel;Chile;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Bulgaria;Netherlands;Germany;Norway;Japan;Korea, Republic of | |||
| 2 | EUCTR2011-001266-17-DK (EUCTR) | 11/10/2012 | 11/10/2012 | An open-label extension study of the long-term safety,tolerability and efficacy of GSK2402968 in subjects with Duchenne Muscular Dystrophy | An open-label extension study of the long-term safety,tolerability and efficacy of GSK2402968 in subjects withDuchenne Muscular Dystrophy - N/A | Duchenne Muscular Dystrophy MedDRA version: 15.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: GSK2402968 Product Code: GSK2402968 | GlaxoSmithKline Research and Development LTD | NULL | Not Recruiting | Female: no Male: yes | 200 | Phase 3 | Taiwan;Spain;Turkey;Israel;Chile;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Bulgaria;Netherlands;Germany;Norway;Japan;Korea, Republic of | ||
| 3 | EUCTR2011-001266-17-BG (EUCTR) | 09/08/2012 | 29/05/2012 | An open-label extension study of the long-term safety,tolerability and efficacy of GSK2402968 in subjects with Duchenne Muscular Dystrophy | An open-label extension study of the long-term safety,tolerability and efficacy of GSK2402968 in subjects withDuchenne Muscular Dystrophy - N/A | Duchenne Muscular Dystrophy MedDRA version: 16.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: GSK2402968 Product Code: GSK2402968 | GlaxoSmithKline Research and Development LTD | NULL | Not Recruiting | Female: no Male: yes | 200 | Taiwan;Spain;Turkey;Israel;Chile;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Bulgaria;Netherlands;Germany;Norway;Japan;Korea, Republic of | |||
| 4 | EUCTR2011-001266-17-HU (EUCTR) | 02/08/2012 | 18/06/2012 | An open-label extension study of the long-term safety,tolerability and efficacy of GSK2402968 in subjects with Duchenne Muscular Dystrophy | An open-label extension study of the long-term safety,tolerability and efficacy of GSK2402968 in subjects withDuchenne Muscular Dystrophy - N/A | Duchenne Muscular Dystrophy MedDRA version: 14.1;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: GSK2402968 Product Code: GSK2402968 INN or Proposed INN: NA | GlaxoSmithKline Research and Development LTD | NULL | Not Recruiting | Female: no Male: yes | 200 | Taiwan;Spain;Turkey;Israel;Chile;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Bulgaria;Netherlands;Germany;Norway;Japan;Korea, Republic of | |||
| 5 | EUCTR2010-020069-26-HU (EUCTR) | 25/05/2012 | 28/02/2012 | A phase III, randomized, double blind, placebo-controlledclinical study to assess the efficacy and safety of GSK2402968 in subjects with Duchenne muscular dystrophy - N/A | A phase III, randomized, double blind, placebo-controlledclinical study to assess the efficacy and safety of GSK2402968 in subjects with Duchenne muscular dystrophy - N/A | Duchenne muscular dystrophy MedDRA version: 14.1;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Code: GSK2402968 | GlaxoSmithKline Research and Development LTD | NULL | Not Recruiting | Female: no Male: yes | 180 | Phase 3 | Japan;Taiwan;Spain;Korea, Democratic People's Republic of;Russian Federation;Chile;Italy;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Norway;Netherlands;Germany | ||
| 6 | EUCTR2011-001266-17-IT (EUCTR) | 20/03/2012 | 08/03/2012 | An open-label extension study of the long-term safety, tolerability and efficacy of GSK2402968 in subjects with Duchenne Muscular Dystrophy | An open-label extension study of the long-term safety, tolerability and efficacy of GSK2402968 in subjects with Duchenne Muscular Dystrophy | Duchenne Muscular Dystrophy MedDRA version: 14.1;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: GSK2402968 Product Code: GSK2402968 INN or Proposed INN: NA Other descriptive name: NA | GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD. | NULL | Not Recruiting | Female: no Male: yes | 200 | Taiwan;Spain;Turkey;Russian Federation;Chile;Israel;United Kingdom;Italy;Czech Republic;Hungary;Canada;Argentina;Brazil;Denmark;Australia;Bulgaria;Netherlands;Germany;Japan;Korea, Republic of | |||
| 7 | EUCTR2011-001266-17-ES (EUCTR) | 18/11/2011 | 03/10/2011 | An open-label extension study of the long-term safety,tolerability and efficacy of GSK2402968 in subjects with Duchenne Muscular Dystrophy | An open-label extension study of the long-term safety,tolerability and efficacy of GSK2402968 in subjects withDuchenne Muscular Dystrophy | Duchenne Muscular Dystrophy MedDRA version: 14.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: GSK2402968 Product Code: GSK2402968 INN or Proposed INN: GSK2402968 | GlaxoSmithKline, S.A. | NULL | Not Recruiting | Female: no Male: yes | 200 | Taiwan;Spain;Turkey;Israel;Russian Federation;Chile;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Bulgaria;Netherlands;Germany;Norway;Japan;Korea, Republic of | |||
| 8 | EUCTR2011-001266-17-DE (EUCTR) | 16/11/2011 | 31/08/2011 | An open-label extension study of the long-term safety,tolerability and efficacy of GSK2402968 in subjects with Duchenne Muscular Dystrophy | An open-label extension study of the long-term safety,tolerability and efficacy of GSK2402968 in subjects withDuchenne Muscular Dystrophy - N/A | Duchenne Muscular Dystrophy MedDRA version: 16.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: GSK2402968 Product Code: GSK2402968 | GlaxoSmithKline Research and Development LTD | NULL | Not Recruiting | Female: no Male: yes | 200 | Taiwan;Spain;Turkey;Israel;Chile;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Bulgaria;Netherlands;Germany;Norway;Japan;Korea, Republic of | |||
| 9 | EUCTR2011-001266-17-NL (EUCTR) | 03/11/2011 | 28/09/2011 | An open-label extension study of the long-term safety,tolerability and efficacy of GSK2402968 in subjects with Duchenne Muscular Dystrophy | An open-label extension study of the long-term safety,tolerability and efficacy of GSK2402968 in subjects withDuchenne Muscular Dystrophy - N/A | Duchenne Muscular Dystrophy MedDRA version: 14.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: GSK2402968 Product Code: GSK2402968 | GlaxoSmithKline Research and Development LTD | NULL | Not Recruiting | Female: no Male: yes | 200 | Taiwan;Spain;Turkey;Israel;Chile;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Bulgaria;Germany;Netherlands;Norway;Japan;Korea, Republic of | |||
| 10 | NCT01462292 (ClinicalTrials.gov) | October 26, 2011 | 3/10/2011 | A Clinical Study to Assess Two Doses of GSK2402968 in Subjects With Duchenne Muscular Dystrophy (DMD) | An Exploratory Study to Assess Two Doses of GSK2402968 in the Treatment of Ambulant Boys With Duchenne Muscular Dystrophy | Muscular Dystrophies | Drug: GSK2402968 3mg/kg/week;Drug: GSK2402968 6 mg/kg/week;Drug: Placebo to match GSK2402968 3 mg/kg/week;Drug: Placebo to match GSK2402968 6 mg/kg/week | GlaxoSmithKline | NULL | Completed | 5 Years | N/A | Male | 51 | Phase 2 | United States |
| 11 | EUCTR2011-001266-17-GB (EUCTR) | 03/10/2011 | 31/08/2011 | An open-label extension study of the long-term safety, tolerability and efficacy of GSK2402968 in subjects with Duchenne Muscular Dystrophy | An open-label extension study of the long-term safety, tolerability and efficacy of GSK2402968 in subjects with Duchenne Muscular Dystrophy - N/A | Duchenne Muscular Dystrophy MedDRA version: 14.1;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: GSK2402968 Product Code: GSK2402968 | GlaxoSmithKline Research and Development LTD | NULL | Not Recruiting | Female: no Male: yes | 200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Taiwan;Spain;Turkey;Israel;Russian Federation;Chile;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Bulgaria;Netherlands;Germany;Norway;Japan;Korea, Republic of | ||
| 12 | NCT01480245 (ClinicalTrials.gov) | September 2011 | 23/11/2011 | Open Label Study of GSK2402968 in Subjects With Duchenne Muscular Dystrophy | An Open-label Extension Study of the Long-term Safety, Tolerability and Efficacy of GSK2402968 in Subjects With Duchenne Muscular Dystrophy | Muscular Dystrophies | Drug: GSK2402968 | GlaxoSmithKline | NULL | Terminated | 5 Years | N/A | Male | 233 | Phase 3 | Argentina;Australia;Belgium;Brazil;Bulgaria;Canada;Chile;Czech Republic;Denmark;France;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Netherlands;Norway;Poland;Russian Federation;Spain;Taiwan;Turkey;United Kingdom |
| 13 | EUCTR2011-001266-17-BE (EUCTR) | 08/08/2011 | 30/06/2011 | An open-label extension study of the long-term safety,tolerability and efficacy of GSK2402968 in subjects with Duchenne Muscular Dystrophy | An open-label extension study of the long-term safety,tolerability and efficacy of GSK2402968 in subjects withDuchenne Muscular Dystrophy - N/A | Duchenne Muscular Dystrophy MedDRA version: 16.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: GSK2402968 Product Code: GSK2402968 | GlaxoSmithKline Research and Development LTD | NULL | Not Recruiting | Female: no Male: yes | 200 | Phase 3 | Taiwan;Spain;Turkey;Israel;Russian Federation;Chile;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Brazil;Denmark;Australia;Bulgaria;Netherlands;Germany;Norway;Japan;Korea, Republic of | ||
| 14 | EUCTR2010-020069-26-DK (EUCTR) | 15/06/2011 | 18/05/2011 | A phase III, randomized, double blind, placebo-controlled clinical study toassess the efficacy and safety of GSK2402968 in subjects with Duchenne musculardystrophy. | A phase III, randomized, double blind, placebo-controlled clinical study toassess the efficacy and safety of GSK2402968 in subjects with Duchenne musculardystrophy. - N/A | Duchenne muscular dystrophy MedDRA version: 14.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Code: GSK2402968 | GlaxoSmithKline Research and Development LTD | NULL | Not Recruiting | Female: no Male: yes | 180 | Phase 3 | Taiwan;Spain;Korea, Democratic People's Republic of;Russian Federation;Chile;Italy;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Netherlands;Germany;Norway;Japan | ||
| 15 | EUCTR2010-020069-26-ES (EUCTR) | 11/04/2011 | 18/02/2011 | Ensayo clínico de fase III, aleatorizado, doble ciego, controlado con placebo para evaluar la eficacia y seguridad de GSK2402968 en sujetos con distrofia muscular de Duchenne.A phase III, randomized, double blind, placebo-controlled clinical study toassess the efficacy and safety of GSK2402968 in subjects with Duchenne musculardystrophy. - N/A | Ensayo clínico de fase III, aleatorizado, doble ciego, controlado con placebo para evaluar la eficacia y seguridad de GSK2402968 en sujetos con distrofia muscular de Duchenne.A phase III, randomized, double blind, placebo-controlled clinical study toassess the efficacy and safety of GSK2402968 in subjects with Duchenne musculardystrophy. - N/A | Duchenne muscular dystrophy MedDRA version: 12.1;Level: LLT;Classification code 10013801;Term: Duchenne muscular dystrophy MedDRA version: 13;Term: Distrofia muscular de Duchenne | Product Code: GSK2402968 | GlaxoSmithKline.S.A. | NULL | Not Recruiting | Female: no Male: yes | 190 | Phase 3 | France;Hungary;Czech Republic;Poland;Belgium;Spain;Denmark;Norway;Netherlands;Germany;Italy | ||
| 16 | EUCTR2010-020069-26-PL (EUCTR) | 30/03/2011 | 03/01/2011 | A phase III, randomized, double blind, placebo-controlled clinical study toassess the efficacy and safety of GSK2402968 in subjects with Duchenne musculardystrophy. | A phase III, randomized, double blind, placebo-controlled clinical study toassess the efficacy and safety of GSK2402968 in subjects with Duchenne musculardystrophy. - N/A | Duchenne muscular dystrophy MedDRA version: 14.1;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Code: GSK2402968 | GlaxoSmithKline Research and Development LTD | NULL | Not Recruiting | Female: no Male: yes | 180 | Phase 3 | Taiwan;Spain;Korea, Democratic People's Republic of;Russian Federation;Chile;Italy;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Netherlands;Germany;Norway;Japan | ||
| 17 | EUCTR2010-020069-26-BE (EUCTR) | 15/03/2011 | 25/11/2010 | A phase III, randomized, double blind, placebo-controlled clinical study toassess the efficacy and safety of GSK2402968 in subjects with Duchenne musculardystrophy. - N/A | A phase III, randomized, double blind, placebo-controlled clinical study toassess the efficacy and safety of GSK2402968 in subjects with Duchenne musculardystrophy. - N/A | Duchenne muscular dystrophy MedDRA version: 12.1;Level: LLT;Classification code 10013801;Term: Duchenne muscular dystrophy | Product Name: GSK2402968 Product Code: GSK2402968 | GlaxoSmithKline Research and Development LTD | NULL | Not Recruiting | Female: no Male: yes | 180 | Phase 3 | France;Hungary;Czech Republic;Spain;Poland;Belgium;Denmark;Netherlands;Germany;Italy | ||
| 18 | EUCTR2010-020069-26-NL (EUCTR) | 02/03/2011 | 04/11/2010 | A phase III, randomized, double blind, placebo-controlled clinical study toassess the efficacy and safety of GSK2402968 in subjects with Duchenne musculardystrophy. - N/A | A phase III, randomized, double blind, placebo-controlled clinical study toassess the efficacy and safety of GSK2402968 in subjects with Duchenne musculardystrophy. - N/A | Duchenne muscular dystrophy MedDRA version: 12.1;Level: LLT;Classification code 10013801;Term: Duchenne muscular dystrophy | Product Code: GSK2402968 | GlaxoSmithKline Research and Development LTD | NULL | Not Recruiting | Female: no Male: yes | 180 | Phase 3 | France;Hungary;Czech Republic;Spain;Poland;Belgium;Denmark;Germany;Netherlands;Italy | ||
| 19 | EUCTR2010-020069-26-CZ (EUCTR) | 24/02/2011 | 13/01/2011 | A phase III, randomized, double blind, placebo-controlled clinical study toassess the efficacy and safety of GSK2402968 in subjects with Duchenne musculardystrophy. | A phase III, randomized, double blind, placebo-controlled clinical study toassess the efficacy and safety of GSK2402968 in subjects with Duchenne musculardystrophy. - N/A | Duchenne muscular dystrophy MedDRA version: 14.1;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Code: GSK2402968 | GlaxoSmithKline Research and Development LTD | NULL | Not Recruiting | Female: no Male: yes | 180 | Phase 3 | Taiwan;Spain;Korea, Democratic People's Republic of;Russian Federation;Chile;Italy;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Netherlands;Germany;Norway;Japan | ||
| 20 | NCT01254019 (ClinicalTrials.gov) | December 2, 2010 | 21/10/2010 | A Clinical Study to Assess the Efficacy and Safety of GSK2402968 in Subjects With Duchenne Muscular Dystrophy | A Phase III, Randomized, Double Blind, Placebo-controlled Clinical Study to Assess the Efficacy and Safety of GSK2402968 in Subjects With Duchenne Muscular Dystrophy | Muscular Dystrophies | Drug: GSK2402968 6mg/kg/week | GlaxoSmithKline | NULL | Completed | 5 Years | N/A | Male | 186 | Phase 3 | Argentina;Belgium;Brazil;Canada;Chile;Czechia;Denmark;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Netherlands;Norway;Poland;Russian Federation;Spain;Taiwan;Turkey;Czech Republic |
| 21 | EUCTR2010-018412-32-ES (EUCTR) | 18/11/2010 | 01/12/2010 | Estudio clínico de fase II, doble ciego, explorador, de grupos paralelos y controlado con placebo para evaluar dos pautas posológicas de GSK2402968 para la eficacia, seguridad, tolerabilidad y farmacocinética en sujetos ambulatorios con distrofia muscular de Duchenne | Estudio clínico de fase II, doble ciego, explorador, de grupos paralelos y controlado con placebo para evaluar dos pautas posológicas de GSK2402968 para la eficacia, seguridad, tolerabilidad y farmacocinética en sujetos ambulatorios con distrofia muscular de Duchenne | Distrofia muscular de Duchenne MedDRA version: 12.1;Level: LLT;Classification code 10013801;Term: Duchenne muscular dystrophy | Product Code: GSK2402968 | GlaxoSmithKline Research and Development LTD | NULL | Not Recruiting | Female: no Male: yes | 54 | France;Spain;Netherlands;Germany;United Kingdom | |||
| 22 | EUCTR2010-020069-26-IT (EUCTR) | 16/11/2010 | 21/12/2010 | A phase III, randomized, double blind, placebo-controlled clinical study to assess the efficacy and safety of GSK2402968 in subjects with Duchenne muscular dystrophy - ND | A phase III, randomized, double blind, placebo-controlled clinical study to assess the efficacy and safety of GSK2402968 in subjects with Duchenne muscular dystrophy - ND | Duchenne muscular dystrophy MedDRA version: 9.1;Level: LLT;Classification code 10013801 | Product Name: GSK2402968 Product Code: GSK2402968 INN or Proposed INN: GSK2402968 | GlaxoSmithKline Research and Development LTD | NULL | Not Recruiting | Female: no Male: yes | 180 | Phase 3 | France;Hungary;Czech Republic;Spain;Poland;Belgium;Denmark;Netherlands;Germany;Italy | ||
| 23 | EUCTR2010-020069-26-FR (EUCTR) | 16/09/2010 | 15/07/2010 | A randomized, double-blind, placebo-controlled clinical study to assess the efficacy and safety of GSK2402968 in ambulant subjects with Duchenne muscular dystrophy | A randomized, double-blind, placebo-controlled clinical study to assess the efficacy and safety of GSK2402968 in ambulant subjects with Duchenne muscular dystrophy | Duchenne muscular dystrophy MedDRA version: 12.1;Level: LLT;Classification code 10013801;Term: Duchenne muscular dystrophy | Product Code: GSK2402968 | GlaxoSmithKline Research and Development LTD | NULL | Not Recruiting | Female: no Male: yes | 180 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Hungary;Czech Republic;Spain;Poland;Belgium;Denmark;Norway;Netherlands;Germany;Italy | ||
| 24 | EUCTR2010-018412-32-NL (EUCTR) | 13/09/2010 | 24/05/2010 | A phase II, double blind, exploratory, parallel-group, placebo-controlled clinical study to assess two dosing regimens of GSK2402968 for efficacy, safety, tolerability and pharmacokinetics in ambulant subjects with Duchenne muscular dystrophy - | Duchenne Muscular Dystrophy MedDRA version: 12.1;Level: LLT;Classification code 10013801;Term: Duchenne muscular dystrophy | Product Code: GSK2402968 | GlaxoSmithKline Research and Development LTD | NULL | Not Recruiting | Female: no Male: yes | 54 | Phase 2 | United Kingdom;Germany;Netherlands;France;Spain | |||
| 25 | NCT01153932 (ClinicalTrials.gov) | September 2010 | 29/6/2010 | Phase II Doubleblind Exploratory Study of GSK2402968 in Ambulant Subjects With Duchenne Muscular Dystrophy | A Phase II, Double Blind, Exploratory, Parallel-group, Placebocontrolled Clinical Study to Assess Two Dosing Regimens of GSK2402968 for Efficacy, Safety, Tolerability and Pharmacokinetics in Ambulant Subjects With Duchenne Muscular Dystrophy | Muscular Dystrophies | Drug: GSK2402968;Drug: matched placebo | GlaxoSmithKline | NULL | Completed | 5 Years | N/A | Male | 53 | Phase 2 | Australia;Belgium;France;Germany;Israel;Netherlands;Spain;Turkey;United Kingdom |
| 26 | EUCTR2010-018412-32-DE (EUCTR) | 05/08/2010 | 31/03/2010 | A phase II, double blind, exploratory, parallel-group, placebo-controlled clinical study to assess two dosing regimens of GSK2402968 for efficacy, safety, tolerability and pharmacokinetics in ambulant subjects with Duchenne muscular dystrophy | A phase II, double blind, exploratory, parallel-group, placebo-controlled clinical study to assess two dosing regimens of GSK2402968 for efficacy, safety, tolerability and pharmacokinetics in ambulant subjects with Duchenne muscular dystrophy | Duchenne Muscular Dystrophy MedDRA version: 14.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders | Product Code: GSK2402968 | GlaxoSmithKline Research and Development LTD | NULL | Not Recruiting | Female: no Male: yes | 54 | Phase 2 | France;Spain;Turkey;Australia;Israel;Netherlands;Germany;United Kingdom | ||
| 27 | EUCTR2010-018412-32-FR (EUCTR) | 03/08/2010 | 03/08/2010 | A phase II, double blind, exploratory, parallel-group, placebo-controlled clinical study to assess two dosing regimens of GSK2402968 for efficacy, safety, tolerability and pharmacokinetics in ambulant subjects with Duchenne muscular dystrophy | A phase II, double blind, exploratory, parallel-group, placebo-controlled clinical study to assess two dosing regimens of GSK2402968 for efficacy, safety, tolerability and pharmacokinetics in ambulant subjects with Duchenne muscular dystrophy | Duchenne Muscular Dystrophy MedDRA version: 12.1;Level: LLT;Classification code 10013801;Term: Duchenne muscular dystrophy | Product Code: GSK2402968 | GlaxoSmithKline Research and Development LTD | NULL | Not Recruiting | Female: no Male: yes | 54 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Spain;Belgium;Netherlands;Germany;United Kingdom | ||
| 28 | NCT01128855 (ClinicalTrials.gov) | July 12, 2010 | 20/5/2010 | A Double-blind, Escalating Dose, Randomized, Placebo-controlled Study Assessing PK, Safety, Tolerability in Non-ambulant DMD Subjects | A Double-blind, Escalating Dose, Randomized, Placebo-controlled Study to Assess the Pharmacokinetics, Safety and Tolerability of Single Subcutaneous Injections of GSK2402968 in Non-ambulant Subjects With Duchenne Muscular Dystrophy | Muscular Dystrophies | Drug: 3 mg/kg GSK2402968;Drug: 6 mg/kg GSK2402968;Drug: 9 mg/kg GSK2402968;Drug: 12 mg/kg GSK2402968;Other: Placebo | GlaxoSmithKline | NULL | Completed | 9 Years | N/A | Male | 20 | Phase 1 | United States;France |
| 29 | EUCTR2010-018412-32-GB (EUCTR) | 17/06/2010 | 16/04/2010 | A phase II, double blind, exploratory, parallel-group, placebo-controlled clinical study to assess two dosing regimens of GSK2402968 for efficacy, safety, tolerability and pharmacokinetics in ambulant subjects with Duchenne muscular dystrophy | A phase II, double blind, exploratory, parallel-group, placebo-controlled clinical study to assess two dosing regimens of GSK2402968 for efficacy, safety, tolerability and pharmacokinetics in ambulant subjects with Duchenne muscular dystrophy | Duchenne Muscular Dystrophy MedDRA version: 14.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders | Product Code: GSK2402968 | GlaxoSmithKline Research and Development LTD | NULL | Not Recruiting | Female: no Male: yes | 54 | Phase 2 | France;Spain;Turkey;Australia;Israel;Netherlands;Germany;United Kingdom | ||
| 30 | EUCTR2010-018412-32-BE (EUCTR) | 15/06/2010 | 07/04/2010 | A phase II, double blind, exploratory, parallel-group, placebo-controlled clinical study to assess two dosing regimens of GSK2402968 for efficacy, safety, tolerability and pharmacokinetics in ambulant subjects with Duchenne muscular dystrophy | Duchenne Muscular Dystrophy MedDRA version: 14.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders | Product Code: GSK2402968 | GlaxoSmithKline Research and Development LTD | NULL | Not Recruiting | Female: no Male: yes | 54 | Phase 2 | France;Spain;Belgium;Turkey;Australia;Israel;Netherlands;Germany;United Kingdom | |||
| 31 | EUCTR2010-020069-26-NO (EUCTR) | 27/04/2011 | A phase III, randomized, double blind, placebo-controlled clinical study toassess the efficacy and safety of GSK2402968 in subjects with Duchenne musculardystrophy. - N/A | A phase III, randomized, double blind, placebo-controlled clinical study toassess the efficacy and safety of GSK2402968 in subjects with Duchenne musculardystrophy. - N/A | Duchenne muscular dystrophy MedDRA version: 13.1;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders | Product Code: GSK2402968 | GlaxoSmithKline Research and Development LTD | NULL | Not Recruiting | Female: no Male: yes | 180 | Phase 3 | France;Hungary;Czech Republic;Spain;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Italy | |||
| 32 | EUCTR2010-024566-22-FR (EUCTR) | 22/02/2011 | A double-blind, escalating dose, randomized, placebo-controlled study to assess the pharmacokinetics, safety and tolerability of single subcutaneous injections of GSK2402968 in non-ambulant subjects with Duchenne muscular dystrophy - N/A | A double-blind, escalating dose, randomized, placebo-controlled study to assess the pharmacokinetics, safety and tolerability of single subcutaneous injections of GSK2402968 in non-ambulant subjects with Duchenne muscular dystrophy - N/A | Duchenne Muscular Dystrophy MedDRA version: 12.1;Level: LLT;Classification code 10013801;Term: Duchenne muscular dystrophy | Product Name: GSK2402968 Product Code: GSK2402968 | GlaxoSmithKline Research and Development LTD | NULL | NA | Female: no Male: yes | 32 | Phase 1 | France | |||
| 33 | EUCTR2010-020069-26-Outside-EU/EEA (EUCTR) | 09/03/2012 | A phase III, randomized, double blind, placebo-controlled clinical study to assess the efficacy and safety of GSK2402968 in subjects with Duchenne musculardystrophy. | A phase III, randomized, double blind, placebo-controlledclinical study to assess the efficacy and safety of GSK2402968 in subjects with Duchenne muscular dystrophy - N/A | Duchenne muscular dystrophy MedDRA version: 14.1;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Code: GSK2402968 | GlaxoSmithKline Research and Development LTD | NULL | NA | Female: no Male: yes | 180 | Phase 3 | Argentina;Belgium;Brazil;Canada;Chile;Czech Republic;Denmark;France;Germany;Italy;Japan;Korea, Democratic People's Republic of;Netherlands;Norway;Poland;Russian Federation;Spain;Taiwan | |||
| 34 | EUCTR2011-001266-17-Outside-EU/EEA (EUCTR) | 09/03/2012 | An open-label extension study of the long-term safety,tolerability and efficacy of GSK2402968 in subjects with Duchenne Muscular Dystrophy | An open-label extension study of the long-term safety,tolerability and efficacy of GSK2402968 in subjects withDuchenne Muscular Dystrophy - N/A | Duchenne Muscular Dystrophy MedDRA version: 14.1;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: GSK2402968 Product Code: GSK2402968 | GlaxoSmithKline Research and Development LTD | NULL | NA | Female: no Male: yes | 32 | NULL | ||||
| 35 | EUCTR2010-018412-32-Outside-EU/EEA (EUCTR) | 09/03/2012 | A phase II, double blind, exploratory, parallel-group, placebo-controlled clinical study to assess two dosing regimens of GSK2402968 for efficacy, safety, tolerability and pharmacokinetics in ambulant subjects with Duchenne muscular dystrophy | A phase II, double blind, exploratory, parallel-group, placebo-controlled clinical study to assess two dosing regimens of GSK2402968 for efficacy, safety, tolerability and pharmacokinetics in ambulant subjects with Duchenne muscular dystrophy - | Duchenne Muscular Dystrophy MedDRA version: 14.1;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders | Product Code: GSK2402968 | GlaxoSmithKline Research and Development LTD | NULL | NA | Female: no Male: yes | 54 | Phase 2 | Australia;Israel;Turkey | |||
| 36 | EUCTR2010-020069-26-DE (EUCTR) | 22/06/2010 | A phase III, randomized, double blind, placebo-controlled clinical study toassess the efficacy and safety of GSK2402968 in subjects with Duchenne musculardystrophy. | A phase III, randomized, double blind, placebo-controlled clinical study toassess the efficacy and safety of GSK2402968 in subjects with Duchenne musculardystrophy. - N/A | Duchenne muscular dystrophy MedDRA version: 14.1;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Code: GSK2402968 | GlaxoSmithKline Research and Development LTD | NULL | Not Recruiting | Female: no Male: yes | 180 | Phase 3 | Taiwan;Spain;Korea, Democratic People's Republic of;Russian Federation;Chile;Italy;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Netherlands;Germany;Norway;Japan | |||
| 37 | EUCTR2010-024566-22-Outside-EU/EEA (EUCTR) | 09/03/2012 | A clinical study to investigate the pharmacokinetics safety, and tolerability of a single dose of GSK2402968 in non-ambulant subjects with Duchenne muscular dystrophy (GSK Study Number DMD114118) | A double-blind, escalating dose, randomized, placebo-controlled study to assess the pharmacokinetics, safety and tolerability of single subcutaneous injections of GSK2402968 in non-ambulant subjects with Duchenne muscular dystrophy - N/A | Duchenne Muscular Dystrophy MedDRA version: 14.1;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders | Product Name: GSK2402968 Product Code: GSK2402968 | GlaxoSmithKline Research and Development LTD | NULL | NA | Female: no Male: yes | 32 | United States | ||||
| 38 | EUCTR2011-001266-17-FR (EUCTR) | 05/07/2011 | An open-label extension study of the long-term safety,tolerability and efficacy of GSK2402968 in subjects with Duchenne Muscular Dystrophy | An open-label extension study of the long-term safety,tolerability and efficacy of GSK2402968 in subjects withDuchenne Muscular Dystrophy - N/A | Duchenne Muscular Dystrophy MedDRA version: 14.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: GSK2402968 Product Code: GSK2402968 | GlaxoSmithKline Research and Development LTD | NULL | NA | Female: no Male: yes | 200 | Phase 3 | Taiwan;Spain;Turkey;Israel;Chile;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Bulgaria;Netherlands;Germany;Norway;Japan;Korea, Republic of |