WHO ICTRP trial
A study to evluate the safety of Rosuvastatin in Children and Adolescents with…
EUCTR2014-004746-99-BE · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2014-004746-99-BE |
|---|---|
| Public title | A study to evluate the safety of Rosuvastatin in Children and Adolescents with Homozygous Familial Hypercholesterolemia. |
| Scientific title | 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) |
| Primary sponsor | AstraZeneca AB |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | United States;Taiwan;Canada;Malaysia;Belgium;Lebanon;Denmark;Israel;Netherlands;Germany;Sweden |
| Conditions | Hypercholesterolemia - The current trial will study children with Homozygous Familial Hypercholesterolemia (HoFH).;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] |
| Interventions | Trade Name: Crestor Film-Coated Tablet Product Name: Crestor Product Code: ZD4522 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Rosuvastatin calcium CAS Number: 147098-20-2 Concentration unit: mg milligram(s) Concentration… |
| Registration date | Dec 18, 2014 |
| Target size | 20 |
| Secondary IDs | D356NC00001 |
| Registry page | clinicaltrialsregister.eu |
At a glance
- No Results available
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: