WHO ICTRP trial
Study to assess the long term safety and efficacy of AMG 145 in patients with…
EUCTR2012-004357-83-GB · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2012-004357-83-GB |
|---|---|
| Public title | Study to assess the long term safety and efficacy of AMG 145 in patients with high concentrations of lipids in the blood |
| Scientific title | A Multicenter, Controlled, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 145 - OSLER 2 |
| Primary sponsor | Amgen Inc |
| 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;Hong Kong;Spain;Russian Federation;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;Austria;United Kingdom;Czech… |
| Conditions | Primary hyperlipidaemia and mixed dyslipidaemia MedDRA version: 20.0 Level: PT Classification code 10058108 Term: Dyslipidaemia System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 20.0 Level: LLT Classification… |
| Interventions | Product Name: AMG 145 Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: Evolocumab CAS Number: N/A Current Sponsor code: AMG 145 Other descriptive name: AMG 145 Concentration unit: mg/ml… |
| Registration date | Nov 6, 2013 |
| Target size | 4428 |
| Secondary IDs | 20120138;2012-004357-83-IT |
| Registry page | clinicaltrialsregister.eu |
At a glance
- Yes Results available
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: