Trials / Completed
CompletedNCT02808403
Long Term Post Marketing Specified Drug Use Result Survey for Evolocumab in Japan
Long Term Post Marketing Specified Drug Use Result Survey for Evolocumab (AMG 145) in Japan
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 6,000 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The purpose of this post-marketing survey is to obtain real-world information on the safety and effectiveness of evolocumab in Japan.
Detailed description
The objectives of study are to 1) determine the incidence of adverse events and adverse drug reactions among patients receiving evolocumab for up to 2 years, and 2) identify and describe patient characteristics (e.g. demographics, medical history) associated with the safety and effectiveness of evolocumab therapy for the patients with Familial Hypercholesterolemia (Heterozygous or Homozygous) and Hypercholesterolemia in Japan
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | No intervention | No intervention; observation of routine medical care |
Timeline
- Start date
- 2016-06-24
- Primary completion
- 2022-10-31
- Completion
- 2023-03-30
- First posted
- 2016-06-21
- Last updated
- 2024-11-21
Locations
138 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT02808403. Inclusion in this directory is not an endorsement.