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

  
9 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-001615-21-BG
(EUCTR)
06/07/201812/04/2018An extension to Protocol B5161002 to evaluate the long-term safety of as well as to collect data regarding maintenance of effect up to 4 yearsA 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 10017NULLNot 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): noUnited States;Canada;Poland;Australia;Bulgaria;Japan;Italy;United Kingdom
2EUCTR2016-001615-21-IT
(EUCTR)
06/02/201709/01/2017An extension to Protocol B5161002 to evaluate the long-term safety of as well as to collect data regarding maintenance of effect up to 4 yearsA 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 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
95Phase 2United States;Canada;Poland;Australia;Bulgaria;Japan;United Kingdom;Italy
3EUCTR2014-002072-92-BG
(EUCTR)
29/12/201618/10/2016 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 10017NULLNot 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): noUnited States;Canada;Poland;Australia;Bulgaria;Japan;Italy;United Kingdom
4EUCTR2016-001615-21-GB
(EUCTR)
12/12/201621/10/2016An extension to Protocol B5161002 to evaluate the long-term safety of as well as to collect data regarding maintenance of effect up to 4 yearsA 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.NULLNot RecruitingFemale: no
Male: yes
105Phase 2United States;Canada;Poland;Australia;Bulgaria;Japan;Italy;United Kingdom
5NCT02907619
(ClinicalTrials.gov)
October 13, 201614/9/2016An Open-label Extension Study To Evaluate Safety Of PF-06252616 In Boys With Duchenne Muscular DystrophyA MULTICENTER, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY OF PF-06252616 IN BOYS WITH DUCHENNE MUSCULAR DYSTROPHYDuchenne Muscular DystrophyBiological: PF-06252616PfizerNULLTerminated6 Years18 YearsMale59Phase 2United States;Canada;Italy;Japan;United Kingdom
6EUCTR2014-002072-92-PL
(EUCTR)
10/08/201614/07/2016 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 10017NULLNot 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): noUnited States;Canada;Poland;Australia;Bulgaria;Japan;Italy;United Kingdom
7EUCTR2014-002072-92-IT
(EUCTR)
05/03/201512/01/2015A Phase 2 Study to Evaluate The Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of PF-06252616 In Duchenne Muscular DystrophyA 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 10017NULLNot RecruitingFemale: no
Male: yes
105Phase 2United States;Canada;Poland;Bulgaria;United Kingdom;Japan;Italy
8EUCTR2014-002072-92-GB
(EUCTR)
30/12/201416/09/2014A Phase 2 Study to Evaluate The Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of PF-06252616 In Duchenne Muscular DystrophyA 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 10017NULLNot RecruitingFemale: no
Male: yes
105Phase 2United States;Canada;Poland;Australia;Bulgaria;Japan;Italy;United Kingdom
9NCT02310763
(ClinicalTrials.gov)
November 24, 20144/11/2014A Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of PF-06252616 in Duchenne Muscular DystrophyA 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 DYSTROPHYDuchenne Muscular DystrophyBiological: PF-06252616;Drug: PlaceboPfizerNULLTerminated6 Years15 YearsMale121Phase 2United States;Australia;Bulgaria;Canada;Italy;Japan;Poland;United Kingdom