113. 筋ジストロフィー Muscular dystrophy Clinical trials / Disease details
臨床試験数 : 622 / 薬物数 : 485 - (DrugBank : 99) / 標的遺伝子数 : 59 - 標的パスウェイ数 : 168
| 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 | EUCTR2016-001615-21-BG (EUCTR) | 06/07/2018 | 12/04/2018 | An extension to Protocol B5161002 to evaluate the long-term safety of as well as to collect data regarding maintenance of effect up to 4 years | A Multicenter, Open-Label Extension Study to Evaluate the Long Term Safety of PF-06252616 in Boys with Duchenne Muscular Dystrophy | Duchenne's Muscular Dystrophy MedDRA version: 20.0;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 Code: PF-06252616 INN or Proposed INN: PF-06252616 | Pfizer Inc. 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: no Male: yes | 105 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Poland;Australia;Bulgaria;Japan;Italy;United Kingdom | ||
| 2 | EUCTR2016-001615-21-IT (EUCTR) | 06/02/2017 | 09/01/2017 | An extension to Protocol B5161002 to evaluate the long-term safety of as well as to collect data regarding maintenance of effect up to 4 years | A Multicenter, Open-Label Extension Study to Evaluate the Long Term Safety of PF-06252616 in Boys with Duchenne Muscular Dystrophy | Duchenne's Muscular Dystrophy MedDRA version: 19.0;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 Code: PF-06252616 INN or Proposed INN: PF-06252616 Product Code: PF-06252616 INN or Proposed INN: PF-06252616 | Pfizer Inc. 235 East 42nd Street, New York, NY 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 95 | Phase 2 | United States;Canada;Poland;Australia;Bulgaria;Japan;United Kingdom;Italy | ||
| 3 | EUCTR2014-002072-92-BG (EUCTR) | 29/12/2016 | 18/10/2016 | A Phase 2 Study to Evaluate The Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of PF-06252616 In Duchenne Muscular Dystrophy | A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate The Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of PF-06252616 In Ambulatory Boys With Duchenne Muscular Dystrophy | Duchenne's Muscular Dystrophy MedDRA version: 20.0;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 Code: PF-06252616 INN or Proposed INN: PF-06252616 Product Code: PF-06252616 INN or Proposed INN: PF-06252616 | Pfizer Inc. 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: no Male: yes | 105 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Poland;Australia;Bulgaria;Japan;Italy;United Kingdom | ||
| 4 | EUCTR2016-001615-21-GB (EUCTR) | 12/12/2016 | 21/10/2016 | An extension to Protocol B5161002 to evaluate the long-term safety of as well as to collect data regarding maintenance of effect up to 4 years | A Multicenter, Open-Label Extension Study to Evaluate the Long Term Safety of PF-06252616 in Boys with Duchenne Muscular Dystrophy | Duchenne's Muscular Dystrophy MedDRA version: 19.0;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 Code: PF-06252616 INN or Proposed INN: PF-06252616 | Pfizer Inc. | NULL | Not Recruiting | Female: no Male: yes | 105 | Phase 2 | United States;Canada;Poland;Australia;Bulgaria;Japan;Italy;United Kingdom | ||
| 5 | NCT02907619 (ClinicalTrials.gov) | October 13, 2016 | 14/9/2016 | An Open-label Extension Study To Evaluate Safety Of PF-06252616 In Boys With Duchenne Muscular Dystrophy | A MULTICENTER, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY OF PF-06252616 IN BOYS WITH DUCHENNE MUSCULAR DYSTROPHY | Duchenne Muscular Dystrophy | Biological: PF-06252616 | Pfizer | NULL | Terminated | 6 Years | 18 Years | Male | 59 | Phase 2 | United States;Canada;Italy;Japan;United Kingdom |
| 6 | EUCTR2014-002072-92-PL (EUCTR) | 10/08/2016 | 14/07/2016 | A Phase 2 Study to Evaluate The Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of PF-06252616 In Duchenne Muscular Dystrophy | A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate The Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of PF-06252616 In Ambulatory Boys With Duchenne Muscular Dystrophy | Duchenne's Muscular Dystrophy MedDRA version: 20.0;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 Code: PF-06252616 INN or Proposed INN: PF-06252616 Product Code: PF-06252616 INN or Proposed INN: PF-06252616 | Pfizer Inc. 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: no Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Poland;Australia;Bulgaria;Japan;Italy;United Kingdom | ||
| 7 | EUCTR2014-002072-92-IT (EUCTR) | 05/03/2015 | 12/01/2015 | A Phase 2 Study to Evaluate The Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of PF-06252616 In Duchenne Muscular Dystrophy | A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate The Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of PF-06252616 In Ambulatory Boys With Duchenne Muscular Dystrophy | Duchenne's Muscular Dystrophy MedDRA version: 17.1;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 Code: PF-06252616 INN or Proposed INN: - Other descriptive name: PF-06252616 | Pfizer Inc. 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: no Male: yes | 105 | Phase 2 | United States;Canada;Poland;Bulgaria;United Kingdom;Japan;Italy | ||
| 8 | EUCTR2014-002072-92-GB (EUCTR) | 30/12/2014 | 16/09/2014 | A Phase 2 Study to Evaluate The Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of PF-06252616 In Duchenne Muscular Dystrophy | A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate The Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of PF-06252616 In Ambulatory Boys With Duchenne Muscular Dystrophy | Duchenne's Muscular Dystrophy MedDRA version: 19.0;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 Code: PF-06252616 INN or Proposed INN: PF-06252616 Product Code: PF-06252616 INN or Proposed INN: PF-06252616 | Pfizer Inc. 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: no Male: yes | 105 | Phase 2 | United States;Canada;Poland;Australia;Bulgaria;Japan;Italy;United Kingdom | ||
| 9 | NCT02310763 (ClinicalTrials.gov) | November 24, 2014 | 4/11/2014 | A Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of PF-06252616 in Duchenne Muscular Dystrophy | A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTIPLE ASCENDING DOSE STUDY TO EVALUATE THE SAFETY, EFFICACY, PHARMACOKINETICS AND PHARMACODYNAMICS OF PF-06252616 IN AMBULATORY BOYS WITH DUCHENNE MUSCULAR DYSTROPHY | Duchenne Muscular Dystrophy | Biological: PF-06252616;Drug: Placebo | Pfizer | NULL | Terminated | 6 Years | 15 Years | Male | 121 | Phase 2 | United States;Australia;Bulgaria;Canada;Italy;Japan;Poland;United Kingdom |