Study Complete
Sponsor ID
20140409

Long Term Post Marketing Specified Drug Use Result Survey for Evolocumab in Japan

Sponsor ID
20140409
Clinicaltrials.gov ID
NCT02808403
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

The purpose of this post-marketing survey is to obtain real-world information on the safety and effectiveness of evolocumab in Japan.

Additional Study Details

Phase
Phase 4
Product
Evolocumab
Type
Observational
Masking
N/A
Enrollment
6000
Additional Study Details

Protocol Summary

Primary Outcome Measures

Incidence of adverse events and adverse drug reactions

Timeframe: 2 years

Laboratory values for LDL-C

Timeframe: 2 years

Laboratory values for HDL-C

Timeframe: 2 years

Laboratory values for total cholesterol

Timeframe: 2 years

Laboratory values for triglycerides

Timeframe: 2 years

Laboratory values for Apolipoprotein (Apo) A1

Timeframe: 2 years

Laboratory values for Apolipoprotein (Apo) Apo B

Timeframe: 2 years

Laboratory values for Apolipoprotein (Apo) Apo E

Timeframe: 2 years

Laboratory values for lipoprotein(a)

Timeframe: 2 years

Secondary Outcome Measures
Not Available

Locations

Location
Status
Contact Us
Location
Research Site
Uchinada, Ishikawa prefecture, Japan, 920-0293
Status
Not yet recruiting
Location
Research Site
Takasaki, Gunma prefecture, Japan, 370-3513
Status
Recruiting
Location
Research Site
Kahoku gun, Ishikawa prefecture, Japan, 920-0293
Status
Recruiting
Location
Research Site
Ageo city, Saitama prefecture, Japan, 362-8588
Status
Recruiting
Location
Research Site
Chiba City, Chiba prefecture, Japan, 260-8677
Status
Recruiting
Location
Research Site
Takasaki city, Gunma prefecture, Japan, 370-3513
Status
Recruiting
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