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 : 142 / 薬物数 : 114 - (DrugBank : 29) / 標的遺伝子数 : 9 - 標的パスウェイ数 : 18
| 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 | NCT03510715 (ClinicalTrials.gov) | August 31, 2018 | 18/4/2018 | An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia | An Open-Label Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia | Hypercholesterolemia | Drug: Alirocumab SAR236553 (REGN727);Drug: Rosuvastatin;Drug: Ezetimibe;Drug: Cholestyramine;Drug: Nicotinic acid;Drug: Fenofibrate;Drug: Omega-3 fatty acids;Drug: Atorvastatin;Drug: Simvastatin;Drug: Fluvastatin;Drug: Pravastatin;Drug: Lovastatin | Sanofi | Regeneron Pharmaceuticals | Completed | 8 Years | 17 Years | All | 18 | Phase 3 | Brazil;Canada;Denmark;Mexico;Netherlands;Russian Federation;Slovenia;Spain;Taiwan;Turkey;Austria;France;Italy;Norway;United States |
| 2 | NCT02434497 (ClinicalTrials.gov) | June 6, 2015 | 7/4/2015 | A Study to Evaluate the Safety of Rosuvastatin in Children and Adolescents With Homozygous Familial Hypercholesterolemia | An Open-Label Long-Term Extension to the Randomized, Double-blind, Placebo-controlled, Multi-center, Cross-over Study of Rosuvastatin in Children and Adolescents (Aged 6 to <18 Years) With Homozygous Familial Hypercholesterolemia (HoFH) | Homozygous Familial Hypercholesterolemia (HoFH) | Drug: Rosuvastatin 20mg | AstraZeneca | NULL | Completed | 6 Years | 18 Years | All | 9 | Phase 3 | Belgium;Canada;Denmark;Israel;Malaysia;Taiwan |
| 3 | EUCTR2014-004746-99-DK (EUCTR) | 27/03/2015 | 27/03/2015 | A study to evluate the safety of Rosuvastatin in Children and Adolescents with Homozygous Familial Hypercholesterolemia. | An Open-Label Long-Term Extension to the Randomized, Double-blind, Placebo-controlled, Multi-center, Cross-over Study of Rosuvastatin in Children and Adolescents (aged 6 to <18 years) with Homozygous Familial Hypercholesterolemia (HoFH) | Hypercholesterolemia - The current trial will study children with Homozygous Familial Hypercholesterolemia (HoFH). MedDRA version: 19.0;Level: LLT;Classification code 10054380;Term: Familial hypercholesterolemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Crestor Film-Coated Tablet Product Name: Crestor Product Code: ZD4522 INN or Proposed INN: Rosuvastatin calcium | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 3 | United States;Taiwan;Canada;Malaysia;Belgium;Lebanon;Denmark;Israel;Netherlands;Germany;Sweden | ||
| 4 | EUCTR2014-004746-99-BE (EUCTR) | 23/02/2015 | 18/12/2014 | A study to evluate the safety of Rosuvastatin in Children and Adolescents with Homozygous Familial Hypercholesterolemia. | An Open-Label Long-Term Extension to the Randomized, Double-blind, Placebo-controlled, Multi-center, Cross-over Study of Rosuvastatin in Children and Adolescents (aged 6 to <18 years) with Homozygous Familial Hypercholesterolemia (HoFH) | Hypercholesterolemia - The current trial will study children with Homozygous Familial Hypercholesterolemia (HoFH).;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Crestor Film-Coated Tablet Product Name: Crestor Product Code: ZD4522 INN or Proposed INN: Rosuvastatin calcium | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 3 | United States;Taiwan;Canada;Malaysia;Belgium;Lebanon;Denmark;Israel;Netherlands;Germany;Sweden | ||
| 5 | EUCTR2014-000972-24-DK (EUCTR) | 17/12/2014 | 25/09/2014 | A study to evaluate the effect of Rosuvastatin on fatty acids in Children and Adolescents with Homozygous Familial Hypercholesterolemia | A Randomized, Double blind, Placebo controlled, Multi center, Cross over Study of Rosuvastatin in Children and Adolescents (aged 6 to <18 years) with Homozygous Familial Hypercholesterolemia (HoFH) - HYDRA | Hypercholesterolemia - The current trial will study children with Homozygous Familial Hypercholesterolemia (HoFH) MedDRA version: 17.0;Level: LLT;Classification code 10054380;Term: Familial hypercholesterolemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Crestor Tablets (calcium rosuvastatin) Film-Coated tablets Product Name: Crestor Product Code: ZD4522 INN or Proposed INN: calcium rosuvastatin | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 25 | United States;Taiwan;Canada;Malaysia;Belgium;Lebanon;Denmark;Israel;Germany;Netherlands;Sweden | |||
| 6 | EUCTR2014-000972-24-DE (EUCTR) | 17/11/2014 | 26/09/2014 | A study to evaluate the effect of Rosuvastatin on fatty acids in Children and Adolescents with Homozygous Familial Hypercholesterolemia | A Randomized, Double blind, Placebo controlled, Multi center, Cross over Study of Rosuvastatin in Children and Adolescents (aged 6 to <18 years) with Homozygous Familial Hypercholesterolemia (HoFH) - HYDRA | Hypercholesterolemia - The current trial will study children with Homozygous Familial Hypercholesterolemia (HoFH) MedDRA version: 17.1;Level: LLT;Classification code 10054380;Term: Familial hypercholesterolemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Crestor Tablets (calcium rosuvastatin) Film-Coated tablets Product Name: Crestor Product Code: ZD4522 INN or Proposed INN: calcium rosuvastatin Trade Name: Crestor Tablets (calcium rosuvastatin) Film-Coated tablets Product Name: Crestor Product Code: ZD4522 INN or Proposed INN: calcium rosuvastatin | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 25 | United States;Taiwan;Hong Kong;Israel;United Kingdom;Czech Republic;Belgium;Denmark;Australia;South Africa;Germany;Netherlands;Norway;Sweden | |||
| 7 | NCT02226198 (ClinicalTrials.gov) | November 2014 | 14/8/2014 | A Study to Evaluate the Efficacy and Safety of Rosuvastatin in Children and Adolescents With Homozygous Familial Hypercholesterolemia | A Randomized, Double-blind, Placebo-controlled, Multi-center, Cross-over Study of Rosuvastatin in Children and Adolescents (Aged 6 to <18 Years) With Homozygous Familial Hypercholesterolemia (HoFH) | Homozygous Familial Hypercholesterolemia (HoFH) | Drug: Rosuvastatin 20mg;Drug: Placebo | AstraZeneca | NULL | Completed | 6 Years | 17 Years | All | 20 | Phase 3 | Belgium;Canada;Denmark;Israel;Malaysia;Netherlands;Taiwan;Germany;Lebanon;Sweden;United States |
| 8 | EUCTR2014-000972-24-BE (EUCTR) | 27/10/2014 | 11/09/2014 | A study to evaluate the effect of Rosuvastatin on fatty acids in Children and Adolescents with Homozygous Familial Hypercholesterolemia | A Randomized, Double blind, Placebo controlled, Multi center, Cross over Study of Rosuvastatin in Children and Adolescents (aged 6 to <18 years) with Homozygous Familial Hypercholesterolemia (HoFH) - HYDRA | Hypercholesterolemia - The current trial will study children with Homozygous Familial Hypercholesterolemia (HoFH) MedDRA version: 17.1;Level: LLT;Classification code 10054380;Term: Familial hypercholesterolemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Crestor Tablets (calcium rosuvastatin) Film-Coated tablets Product Name: Crestor Product Code: ZD4522 INN or Proposed INN: calcium rosuvastatin | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 25 | Phase 3 | United States;Taiwan;Hong Kong;Israel;United Kingdom;Czech Republic;Belgium;Australia;Denmark;South Africa;Germany;Netherlands;Norway;Sweden | ||
| 9 | EUCTR2014-000972-24-NL (EUCTR) | 20/10/2014 | 05/08/2014 | A study to evaluate the effect of Rosuvastatin on fatty acids in Children and Adolescents with Homozygous Familial Hypercholesterolemia | A Randomized, Double blind, Placebo controlled, Multi center, Cross over Study of Rosuvastatin in Children and Adolescents (aged 6 to <18 years) with Homozygous Familial Hypercholesterolemia (HoFH) - HYDRA | Hypercholesterolemia - The current trial will study children with Homozygous Familial Hypercholesterolemia (HoFH) MedDRA version: 17.1;Level: LLT;Classification code 10054380;Term: Familial hypercholesterolemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Crestor Tablets (calcium rosuvastatin) Film-Coated tablets Product Name: Crestor Product Code: ZD4522 INN or Proposed INN: calcium rosuvastatin | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 25 | United States;Taiwan;Hong Kong;Israel;United Kingdom;Czech Republic;Belgium;Australia;Denmark;South Africa;Germany;Netherlands;Norway;Sweden | |||
| 10 | EUCTR2014-000972-24-SE (EUCTR) | 20/08/2014 | 30/06/2014 | A study to evaluate the effect of Rosuvastatin on fatty acids in Children and Adolescents with Homozygous Familial Hypercholesterolemia | A Randomized, Double blind, Placebo controlled, Multi center, Cross over Study of Rosuvastatin in Children and Adolescents (aged 6 to <18 years) with Homozygous Familial Hypercholesterolemia (HoFH) - HYDRA | Hypercholesterolemia - The current trial will study children with Homozygous Familial Hypercholesterolemia (HoFH) MedDRA version: 17.1;Level: LLT;Classification code 10054380;Term: Familial hypercholesterolemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Crestor Tablets (calcium rosuvastatin) Film-Coated tablets Product Name: Crestor Product Code: ZD4522 INN or Proposed INN: calcium rosuvastatin | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 25 | United States;Taiwan;Hong Kong;Israel;United Kingdom;Czech Republic;Belgium;Australia;Denmark;South Africa;Germany;Netherlands;Norway;Sweden | |||
| 11 | EUCTR2014-004746-99-SE (EUCTR) | 23/12/2014 | A study to evluate the safety of Rosuvastatin in Children and Adolescents with Homozygous Familial Hypercholesterolemia. | An Open-Label Long-Term Extension to the Randomized, Double-blind, Placebo-controlled, Multi-center, Cross-over Study of Rosuvastatin in Children and Adolescents (aged 6 to <18 years) with Homozygous Familial Hypercholesterolemia (HoFH) | Hypercholesterolemia - The current trial will study children with Homozygous Familial Hypercholesterolemia (HoFH).;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Crestor Film-Coated Tablet Product Name: Crestor Product Code: ZD4522 INN or Proposed INN: Rosuvastatin calcium | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 3 | United States;Taiwan;Canada;Malaysia;Belgium;Lebanon;Denmark;Israel;Netherlands;Germany;Sweden |