WHO ICTRP trial
A Phase 3, Multi-Center, Placebo-Controlled, Randomized, Double-Blind, 12-Week…
EUCTR2009-010520-25-NL · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2009-010520-25-NL |
|---|---|
| Public title | A Phase 3, Multi-Center, Placebo-Controlled, Randomized, Double-Blind, 12-Week Study With an Open-Label Extension to Evaluate the Efficacy and Safety of AMR101 in Patients With Fasting Triglyceride Levels =>500 mg/dL and <=2000 mg/dL: The AMR101 MARINE Study - The Marine Study |
| Scientific title | A Phase 3, Multi-Center, Placebo-Controlled, Randomized, Double-Blind, 12-Week Study With an Open-Label Extension to Evaluate the Efficacy and Safety of AMR101 in Patients With Fasting Triglyceride Levels =>500 mg/dL and <=2000 mg/dL: The AMR101 MARINE Study - The Marine Study |
| Primary sponsor | Amarin Pharma Inc. |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Countries | Finland;Germany;Netherlands;Denmark;Italy |
| Conditions | Hypertriglyceridemia MedDRA version: 9.1 Level: HLT Classification code 10014486 Term: Elevated triglycerides MedDRA version: 9.1 Level: LLT Classification code 10020870 Term: Hypertriglyceridemia |
| Interventions | Product Name: Ethyl-Eicosapentaenoate [Ethyl-EPA]) Product Code: AMR101 Pharmaceutical Form: Capsule, soft INN or Proposed INN: ETHYL EICOSAPENTAENOATE CAS Number: 73310108 Current Sponsor code: Ethyl-EPA Other descriptive name: EPA-E… |
| Registration date | Jun 7, 2009 |
| Target size | 240 |
| Secondary IDs | AMR-01-01-0016 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: