79. 家族性高コレステロール血症（ホモ接合体） Homozygous familial hypercholesterolemia Clinical trials / Disease details
臨床試験数 : 145 / 薬物数 : 114 - (DrugBank : 26) / 標的遺伝子数 : 8 - 標的パスウェイ数 : 17
| 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 | EUCTR2019-003611-62-NO (EUCTR) | 20/03/2020 | 28/11/2019 | Randomized, Open-Label, Phase 3 Study in which patients will receive LIB003 and Evolocumab to Evaluate the Efficacy and Safety in Homozygous Familial Hypercholesterolemia Patients on Stable Lipid-Lowering Therapy. | Randomized, Open-Label, Cross-Over, Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 with Evolocumab in Homozygous Familial Hypercholesterolemia Patients on Stable Lipid-Lowering Therapy. - LIB003-003 | Homozygous Familial Hypercholesterolemia MedDRA version: 20.0;Level: LLT;Classification code 10057080;Term: Homozygous familial hypercholesterolemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Code: LIB003 INN or Proposed INN: not available Other descriptive name: LIB003 Trade Name: Repatha (evolocumab) INN or Proposed INN: EVOLOCUMAB | LIB Therapeutics, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | Phase 3 | United States;Turkey;Israel;South Africa;Norway | ||
| 2 | EUCTR2015-002276-25-PT (EUCTR) | 29/07/2019 | 15/11/2018 | Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozygous Familial Hypercholesterolemia or Homozygous Familial Hypercholesterolemia | Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Evolocumab for LDL-C Reduction, as Add-on to Diet and Lipid-lowering Therapy, in Pediatric Subjects From 10 to 17 Years of Age With Heterozygous Familial Hypercholesterolemia (HeFH) or Homozygous Familial Hypercholesterolemia (HoFH) - HAUSER-OLE | Hypercholesterolemia MedDRA version: 20.0;Level: LLT;Classification code 10057100;Term: Homozygous familial hypercholesterolaemia;System Organ Class: 100000004850 MedDRA version: 20.0;Classification code 10057099;Term: Heterozygous familial hypercholesterolaemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Trade Name: Repatha 140 mg Solution for Injection in Pre-filled Pen Product Name: Evolocumab Product Code: AMG 145 INN or Proposed INN: EVOLOCUMAB Trade Name: Repatha 420 mg solution for injection in cartridge Product Name: Evolocumab Product Code: AMG 145 INN or Proposed INN: EVOLOCUMAB | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 115 | Phase 3 | Portugal;Czechia;Slovenia;Greece;Spain;Turkey;Austria;Russian Federation;Colombia;United Kingdom;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Australia;South Africa;Norway;Netherlands;Germany;New Zealand | ||
| 3 | EUCTR2015-002276-25-SI (EUCTR) | 10/06/2019 | 06/03/2019 | Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozygous Familial Hypercholesterolemia or Homozygous Familial Hypercholesterolemia | Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Evolocumab for LDL-C Reduction, as Add-on to Diet and Lipid-lowering Therapy, in Pediatric Subjects From 10 to 17 Years of Age With Heterozygous Familial Hypercholesterolemia (HeFH) or Homozygous Familial Hypercholesterolemia (HoFH) - HAUSER-OLE | Hypercholesterolemia MedDRA version: 20.0;Level: LLT;Classification code 10057100;Term: Homozygous familial hypercholesterolaemia;System Organ Class: 100000004850 MedDRA version: 20.0;Classification code 10057099;Term: Heterozygous familial hypercholesterolaemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Trade Name: Repatha 140 mg Solution for Injection in Pre-filled Pen Product Name: Evolocumab Product Code: AMG 145 Trade Name: Repatha 420 mg solution for injection in cartridge Product Name: Evolocumab Product Code: AMG 145 | Amgen Europe B.V. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Portugal;Taiwan;Greece;Spain;Ukraine;Russian Federation;Colombia;Italy;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Swaziland;Brazil;Belgium;Poland;Germany;Norway | ||
| 4 | EUCTR2015-002276-25-PL (EUCTR) | 25/01/2019 | 28/03/2019 | Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozygous Familial Hypercholesterolemia or Homozygous Familial Hypercholesterolemia | Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Evolocumab for LDL-C Reduction, as Add-on to Diet and Lipid-lowering Therapy, in Pediatric Subjects From 10 to 17 Years of Age With Heterozygous Familial Hypercholesterolemia (HeFH) or Homozygous Familial Hypercholesterolemia (HoFH) - HAUSER-OLE | Hypercholesterolemia MedDRA version: 20.0;Level: LLT;Classification code 10057100;Term: Homozygous familial hypercholesterolaemia;System Organ Class: 100000004850 MedDRA version: 20.0;Classification code 10057099;Term: Heterozygous familial hypercholesterolaemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Trade Name: Repatha 140 mg Solution for Injection in Pre-filled Pen Product Name: Evolocumab Product Code: AMG 145 INN or Proposed INN: EVOLOCUMAB Trade Name: Repatha 420 mg solution for injection in cartridge Product Name: Evolocumab Product Code: AMG 145 INN or Proposed INN: EVOLOCUMAB | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 115 | Phase 3 | United States;Portugal;Taiwan;Greece;Spain;Ukraine;Russian Federation;Colombia;Italy;Malaysia;Australia;South Africa;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Poland;Belgium;Germany;Norway;New Zealand | ||
| 5 | NCT03403374 (ClinicalTrials.gov) | August 4, 2018 | 3/1/2018 | Safety and Tolerability of Repatha® (Evolocumab) in Indian Participants With Homozygous Familial Hypercholesterolemia | A Multicenter, Open-label, Single-arm, Study to Evaluate Safety and Tolerability of Repatha in Patients With Homozygous Familial Hypercholesterolemia (HoFH) in India | Homozygous Familial Hypercholesterolemia HoFH | Drug: evolocumab | Amgen | NULL | Completed | 12 Years | 80 Years | All | 30 | Phase 4 | India |
| 6 | EUCTR2015-002276-25-NL (EUCTR) | 11/04/2017 | 22/11/2016 | Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozygous Familial Hypercholesterolemia or Homozygous Familial Hypercholesterolemia | Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Evolocumab for LDL-C Reduction, as Add-on to Diet and Lipid-lowering Therapy, in Pediatric Subjects From 10 to 17 Years of Age With Heterozygous Familial Hypercholesterolemia (HeFH) or Homozygous Familial Hypercholesterolemia (HoFH) - HAUSER-OLE | Hypercholesterolemia MedDRA version: 20.0;Level: LLT;Classification code 10057100;Term: Homozygous familial hypercholesterolaemia;System Organ Class: 100000004850 MedDRA version: 20.0;Classification code 10057099;Term: Heterozygous familial hypercholesterolaemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Trade Name: Repatha 140 mg Solution for Injection in Pre-filled Pen Product Name: Evolocumab Product Code: AMG 145 INN or Proposed INN: EVOLOCUMAB Trade Name: Repatha 420 mg solution for injection in cartridge Product Name: Evolocumab Product Code: AMG 145 INN or Proposed INN: EVOLOCUMAB | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 124 | Phase 3 | Portugal;Czechia;Slovenia;Greece;Spain;Turkey;Austria;Russian Federation;Colombia;United Kingdom;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Australia;South Africa;Norway;Netherlands;Germany;New Zealand | ||
| 7 | EUCTR2015-002276-25-ES (EUCTR) | 27/02/2017 | 05/08/2016 | Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozygous Familial Hypercholesterolemia or Homozygous Familial Hypercholesterolemia | Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Evolocumab for LDL-C Reduction, as Add-on to Diet and Lipid-lowering Therapy, in Pediatric Subjects From 10 to 17 Years of Age With Heterozygous Familial Hypercholesterolemia (HeFH) or Homozygous Familial Hypercholesterolemia (HoFH) - HAUSER-OLE | Hypercholesterolemia MedDRA version: 19.0;Level: LLT;Classification code 10057100;Term: Homozygous familial hypercholesterolaemia;System Organ Class: 100000004850 MedDRA version: 19.0;Classification code 10057099;Term: Heterozygous familial hypercholesterolaemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Trade Name: Repatha 140 mg Solution for Injection in Pre-filled Pen Product Name: Evolocumab Product Code: AMG 145 INN or Proposed INN: EVOLOCUMAB | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 115 | Phase 3 | Portugal;Slovenia;Greece;Spain;Turkey;Austria;Colombia;Italy;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Australia;South Africa;Netherlands;Germany;Norway;New Zealand | ||
| 8 | EUCTR2015-002276-25-DE (EUCTR) | 21/10/2016 | 05/04/2016 | Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Evolocumab for LDL-C Reduction, as Add-on to Diet and Lipid-lowering Therapy, in Pediatric Subjects From 10 to 17 Years of Age With Heterozygous Familial Hypercholesterolemia (HeFH) or Homozygous Familial Hypercholesterolemia (HoFH) | Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Evolocumab for LDL-C Reduction, as Add-on to Diet and Lipid-lowering Therapy, in Pediatric Subjects From 10 to 17 Years of Age With Heterozygous Familial Hypercholesterolemia (HeFH) or Homozygous Familial Hypercholesterolemia (HoFH) | Hypercholesterolemia MedDRA version: 18.1;Level: LLT;Classification code 10057100;Term: Homozygous familial hypercholesterolaemia;System Organ Class: 100000004850 MedDRA version: 18.1;Classification code 10057099;Term: Heterozygous familial hypercholesterolaemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Trade Name: Repatha 140 mg Solution for Injection in Pre-filled Pen Product Name: Evolocumab Product Code: AMG 145 INN or Proposed INN: EVOLOCUMAB | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 115 | Phase 3 | Portugal;Slovenia;Greece;Spain;Turkey;Austria;Colombia;Italy;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Australia;South Africa;Netherlands;Germany;Norway;New Zealand | ||
| 9 | EUCTR2015-002276-25-CZ (EUCTR) | 06/10/2016 | 04/05/2016 | Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozygous Familial Hypercholesterolemia or Homozygous Familial Hypercholesterolemia | Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Evolocumab for LDL-C Reduction, as Add-on to Diet and Lipid-lowering Therapy, in Pediatric Subjects From 10 to 17 Years of Age With Heterozygous Familial Hypercholesterolemia (HeFH) or Homozygous Familial Hypercholesterolemia (HoFH) - HAUSER-OLE | Hypercholesterolemia MedDRA version: 20.0;Level: LLT;Classification code 10057100;Term: Homozygous familial hypercholesterolaemia;System Organ Class: 100000004850 MedDRA version: 20.0;Classification code 10057099;Term: Heterozygous familial hypercholesterolaemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Trade Name: Repatha 140 mg Solution for Injection in Pre-filled Pen Product Name: Evolocumab Product Code: AMG 145 INN or Proposed INN: EVOLOCUMAB Trade Name: Repatha 420 mg solution for injection in cartridge Product Name: Evolocumab Product Code: AMG 145 INN or Proposed INN: EVOLOCUMAB | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 115 | Phase 3 | Portugal;Slovenia;Greece;Spain;Turkey;Austria;Colombia;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Australia;South Africa;Netherlands;Germany;Norway;New Zealand | ||
| 10 | EUCTR2015-002276-25-IT (EUCTR) | 25/07/2016 | 15/06/2021 | Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozygous Familial Hypercholesterolemia or Homozygous Familial Hypercholesterolemia | Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Evolocumab for LDL-C Reduction, as Add-on to Diet and Lipid-lowering Therapy, in Pediatric Subjects From 10 to 17 Years of Age With Heterozygous Familial Hypercholesterolemia (HeFH) or Homozygous Familial Hypercholesterolemia (HoFH) - Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozyg | Hypercholesterolemia MedDRA version: 20.0;Level: LLT;Classification code 10057100;Term: Homozygous familial hypercholesterolaemia;System Organ Class: 100000004850 MedDRA version: 20.0;Classification code 10057099;Term: Heterozygous familial hypercholesterolaemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Trade Name: Repatha 140 mg soluzione per iniezione in penna preriempita. Product Name: Evolocumab Product Code: AMG 145 INN or Proposed INN: Evolocumab Trade Name: Repatha 420 mg soluzione per iniezione in cartuccia Product Name: Evolocumab Product Code: [AMG 145] INN or Proposed INN: EVOLOCUMAB | AMGEN INC. | NULL | Not Recruiting | Female: yes Male: yes | 115 | Phase 3 | Portugal;Czechia;Slovenia;Greece;Spain;Turkey;Austria;Russian Federation;Colombia;United Kingdom;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Australia;South Africa;Norway;Netherlands;Germany;New Zealand | ||
| 11 | EUCTR2015-002276-25-AT (EUCTR) | 27/06/2016 | 12/04/2016 | Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozygous Familial Hypercholesterolemia or Homozygous Familial Hypercholesterolemia | Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Evolocumab for LDL-C Reduction, as Add-on to Diet and Lipid-lowering Therapy, in Pediatric Subjects From 10 to 17 Years of Age With Heterozygous Familial Hypercholesterolemia (HeFH) or Homozygous Familial Hypercholesterolemia (HoFH) - HAUSER-OLE | Hypercholesterolemia MedDRA version: 20.0;Level: LLT;Classification code 10057100;Term: Homozygous familial hypercholesterolaemia;System Organ Class: 100000004850 MedDRA version: 20.0;Classification code 10057099;Term: Heterozygous familial hypercholesterolaemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Trade Name: Repatha 140 mg Solution for Injection in Pre-filled Pen Product Name: Evolocumab Product Code: AMG 145 INN or Proposed INN: EVOLOCUMAB Trade Name: Repatha 420 mg solution for injection in cartridge Product Name: Evolocumab Product Code: AMG 145 INN or Proposed INN: EVOLOCUMAB | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 115 | Phase 3 | Portugal;Czechia;Slovenia;Greece;Spain;Turkey;Austria;Russian Federation;Colombia;United Kingdom;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Australia;South Africa;Germany;Netherlands;Norway;New Zealand | ||
| 12 | EUCTR2015-002276-25-HU (EUCTR) | 06/06/2016 | 12/04/2016 | Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozygous Familial Hypercholesterolemia or Homozygous Familial Hypercholesterolemia | Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Evolocumab for LDL-C Reduction, as Add-on to Diet and Lipid-lowering Therapy, in Pediatric Subjects From 10 to 17 Years of Age With Heterozygous Familial Hypercholesterolemia (HeFH) or Homozygous Familial Hypercholesterolemia (HoFH) - HAUSER-OLE | Hypercholesterolemia MedDRA version: 19.0;Level: LLT;Classification code 10057100;Term: Homozygous familial hypercholesterolaemia;System Organ Class: 100000004850 MedDRA version: 19.0;Classification code 10057099;Term: Heterozygous familial hypercholesterolaemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Trade Name: Repatha 140 mg Solution for Injection in Pre-filled Pen Product Name: Evolocumab Product Code: AMG 145 INN or Proposed INN: EVOLOCUMAB | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 115 | Phase 3 | Portugal;Slovenia;Greece;Spain;Turkey;Austria;Colombia;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Australia;South Africa;Netherlands;Germany;Norway;New Zealand | ||
| 13 | EUCTR2015-002276-25-GR (EUCTR) | 01/06/2016 | 16/05/2016 | Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozygous Familial Hypercholesterolemia or Homozygous Familial Hypercholesterolemia | Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Evolocumab for LDL-C Reduction, as Add-on to Diet and Lipid-lowering Therapy, in Pediatric Subjects From 10 to 17 Years of Age With Heterozygous Familial Hypercholesterolemia (HeFH) or Homozygous Familial Hypercholesterolemia (HoFH) - HAUSER-OLE | Hypercholesterolemia MedDRA version: 20.0;Level: LLT;Classification code 10057100;Term: Homozygous familial hypercholesterolaemia;System Organ Class: 100000004850 MedDRA version: 20.0;Classification code 10057099;Term: Heterozygous familial hypercholesterolaemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Trade Name: Repatha 140 mg Solution for Injection in Pre-filled Pen Product Name: Evolocumab Product Code: AMG 145 INN or Proposed INN: EVOLOCUMAB | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 115 | Phase 3 | Portugal;Slovenia;Greece;Spain;Turkey;Austria;Colombia;Italy;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Australia;South Africa;Netherlands;Germany;Norway;New Zealand | ||
| 14 | EUCTR2015-002276-25-BE (EUCTR) | 23/05/2016 | 13/04/2016 | Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozygous Familial Hypercholesterolemia or Homozygous Familial Hypercholesterolemia | Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Evolocumab for LDL-C Reduction, as Add-on to Diet and Lipid-lowering Therapy, in Pediatric Subjects From 10 to 17 Years of Age With Heterozygous Familial Hypercholesterolemia (HeFH) or Homozygous Familial Hypercholesterolemia (HoFH) - HAUSER-OLE | Hypercholesterolemia MedDRA version: 20.0;Level: LLT;Classification code 10057100;Term: Homozygous familial hypercholesterolaemia;System Organ Class: 100000004850 MedDRA version: 20.0;Classification code 10057099;Term: Heterozygous familial hypercholesterolaemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Trade Name: Repatha 140 mg Solution for Injection in Pre-filled Pen Product Name: Evolocumab Product Code: AMG 145 INN or Proposed INN: EVOLOCUMAB Trade Name: Repatha 420 mg solution for injection in cartridge Product Name: Evolocumab Product Code: AMG 145 INN or Proposed INN: EVOLOCUMAB | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 115 | Phase 3 | Portugal;Czechia;Slovenia;Greece;Spain;Turkey;Austria;Russian Federation;Colombia;United Kingdom;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Australia;South Africa;Norway;Netherlands;Germany;New Zealand | ||
| 15 | EUCTR2011-005400-15-CZ (EUCTR) | 30/05/2013 | 27/02/2013 | A clinical study to assess the safety and efficacy of AMG 145 on low density cholesterol in subjects with homozygous familial hypercholesterolemia or PCSK9 mutations | A Multicenter, Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of AMG 145 on LDL-C in Subjects With Severe Familial Hypercholesterolemia - TAUSSIG - Trial Assessing long term USe of PCSK9 Inhibition in Subjects wIth Genetic LDL | Familial Hypercholesterolemia MedDRA version: 19.0;Level: LLT;Classification code 10057100;Term: Homozygous familial hypercholesterolaemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: evolocumab Product Code: AMG 145 INN or Proposed INN: Evolocumab Other descriptive name: AMG 145 Trade Name: Repatha 140 mg solution for injection in pre-filled pen Product Name: Evolocumab Product Code: AMG 145 INN or Proposed INN: Evolocumab Other descriptive name: AMG145 Product Name: Evolocumab Product Code: AMG 145 Other descriptive name: AMG145 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2;Phase 3 | United States;Hong Kong;Greece;Spain;Lebanon;Austria;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Brazil;Australia;South Africa;Netherlands;New Zealand;Japan | ||
| 16 | EUCTR2015-002276-25-NO (EUCTR) | 11/04/2016 | Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozygous Familial Hypercholesterolemia or Homozygous Familial Hypercholesterolemia | Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Evolocumab for LDL-C Reduction, as Add-on to Diet and Lipid-lowering Therapy, in Pediatric Subjects From 10 to 17 Years of Age With Heterozygous Familial Hypercholesterolemia (HeFH) or Homozygous Familial Hypercholesterolemia (HoFH) - HAUSER-OLE | Hypercholesterolemia MedDRA version: 20.0;Level: LLT;Classification code 10057100;Term: Homozygous familial hypercholesterolaemia;System Organ Class: 100000004850 MedDRA version: 20.0;Classification code 10057099;Term: Heterozygous familial hypercholesterolaemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Trade Name: Repatha 140 mg Solution for Injection in Pre-filled Pen Product Name: Evolocumab Product Code: AMG 145 INN or Proposed INN: EVOLOCUMAB Trade Name: Repatha 420 mg solution for injection in cartridge Product Name: Evolocumab Product Code: AMG 145 INN or Proposed INN: EVOLOCUMAB | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 115 | Phase 3 | South Africa;Netherlands;Norway;Portugal;Slovenia;Greece;Spain;Turkey;Austria;Colombia;Italy;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Australia;Germany;New Zealand | |||
| 17 | EUCTR2015-002276-25-GB (EUCTR) | 05/04/2016 | Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozygous Familial Hypercholesterolemia or Homozygous Familial Hypercholesterolemia | Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Evolocumab for LDL-C Reduction, as Add-on to Diet and Lipid-lowering Therapy, in Pediatric Subjects From 10 to 17 Years of Age With Heterozygous Familial Hypercholesterolemia (HeFH) or Homozygous Familial Hypercholesterolemia (HoFH) - HAUSER-OLE | Hypercholesterolemia MedDRA version: 20.0;Level: LLT;Classification code 10057100;Term: Homozygous familial hypercholesterolaemia;System Organ Class: 100000004850 MedDRA version: 20.0;Classification code 10057099;Term: Heterozygous familial hypercholesterolaemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Trade Name: Repatha 140 mg Solution for Injection in Pre-filled Pen Product Name: Evolocumab Product Code: AMG 145 INN or Proposed INN: EVOLOCUMAB Trade Name: Repatha 420 mg solution for injection in cartridge Product Name: Evolocumab Product Code: AMG 145 INN or Proposed INN: EVOLOCUMAB | Amgen Inc | NULL | NA | Female: yes Male: yes | 115 | Phase 3 | Portugal;Czechia;Slovenia;Greece;Spain;Turkey;Austria;Russian Federation;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Australia;South Africa;Norway;Germany;Netherlands;New Zealand |