Bi 1265162 25 µg (DrugBank: -)
1 disease| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 299 | 嚢胞性線維症 | 6 |
| 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 | EUCTR2019-000261-21-GB (EUCTR) | 05/11/2019 | 05/06/2019 | A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat® inhaler - BALANCE - CF(TM) 1 | A randomised, double-blind, placebo-controlled and parallel group trial to evaluate efficacy and safety of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler as add-on therapy to standard of care over 4 weeks in patients with cystic fibrosis - BALANCE - CF(TM) 1 | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BI 1265162 10 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 25 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 50 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 100 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 | Boehringer Ingelheim Limited | NULL | Not Recruiting | Female: yes Male: yes | 98 | Phase 2 | United States;France;Canada;Spain;Belgium;Ireland;Germany;United Kingdom;Sweden | ||
| 2 | EUCTR2019-000261-21-ES (EUCTR) | 10/10/2019 | 05/07/2019 | A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat® inhaler | A randomised, double-blind, placebo-controlled and parallel group trial to evaluate efficacy and safety of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler as add-on therapy to standard of care over 4 weeks in patients with cystic fibrosis | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BI 1265162 10 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 25 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 50 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 100 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 | Boehringer Ingelheim, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 98 | Phase 2 | Spain;United States;France;Canada;Belgium;Ireland;Germany;United Kingdom;Sweden | ||
| 3 | EUCTR2019-000261-21-SE (EUCTR) | 08/10/2019 | 29/04/2019 | A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat®inhaler | A randomised, double-blind, placebo-controlled and parallel group trial to evaluate efficacy and safety of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler as add-on therapy to standard of care over 4 weeks in patients with cystic fibrosis | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BI 1265162 10 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 25 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 50 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 100 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 | Boehringer Ingelheim | NULL | Not Recruiting | Female: yes Male: yes | 98 | Phase 2 | United States;France;Canada;Spain;Belgium;Ireland;Germany;United Kingdom;Sweden | ||
| 4 | EUCTR2019-000261-21-BE (EUCTR) | 07/10/2019 | 29/05/2019 | A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat® inhaler – BALANCE – CF(TM)1 | A randomised, double-blind, placebo-controlled and parallel group trial to evaluate efficacy and safety of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler as add-on therapy to standard of care over 4 weeks in patients with cystic fibrosis – BALANCE – CF(TM)1 | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BI 1265162 10 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 25 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 50 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 100 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 | SCS Boehringer Ingelheim Comm.V | NULL | Not Recruiting | Female: yes Male: yes | 98 | Phase 2 | United States;France;Canada;Spain;Belgium;Ireland;Germany;United Kingdom;Sweden | ||
| 5 | EUCTR2019-000261-21-FR (EUCTR) | 19/07/2019 | 21/05/2019 | A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat®inhaler | A randomised, double-blind, placebo-controlled and parallel group trial to evaluate efficacy and safety of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler as add-on therapy to standard of care over 4 weeks in patients with cystic fibrosis | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BI 1265162 10 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 25 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 50 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 100 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 | Boehringer Ingelheim France | NULL | Not Recruiting | Female: yes Male: yes | 98 | Phase 2 | United States;France;Canada;Spain;Belgium;Ireland;Germany;United Kingdom;Sweden | ||
| 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 |
| 6 | EUCTR2019-000261-21-DE (EUCTR) | 16/05/2019 | A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat®inhaler | A randomised, double-blind, placebo-controlled and parallel group trial to evaluate efficacy and safety of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler as add-on therapy to standard of care over 4 weeks in patients with cystic fibrosis | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BI 1265162 10 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 25 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 50 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 100 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 98 | Phase 2 | France;United States;Canada;Belgium;Spain;Ireland;Germany;United Kingdom;Sweden |