Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia

Completed · Phase 3

Conditions studied: Hyperlipidemia and Mixed Dyslipidemia

In brief

This study will contribute to the evaluation of long-term safety, tolerability and efficacy of evolocumab (AMG 145) in adults with hyperlipidemia and adults with mixed dyslipidemia.

Key facts

Study ID

NCT01854918

Run by

Amgen

People needed

3681

Starts

2013-04-23

Expected to finish

2018-05-31

Last updated by the study team

2019-06-11

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Complete a qualifying evolocumab (AMG 145) parent study (ie, Study 20110114 [NCT01763827], 20110115 [NCT01763866], 20110116 [NCT01763905], 20110117 [NCT01763918], 20110109 [NCT01516879], 20120122 [NCT01953328], 20120332 [NCT01984424], 20120348 [NCT01849497], or 20120356 [NCT01879319]).

You may not qualify if…

• Experienced a treatment-related serious adverse event that led to study drug discontinuation in the parent study
• Have an unstable medical condition, in the judgment of the investigator
• Known sensitivity to any of the products to be administered during dosing
• Currently enrolled in another investigational device or drug study (excluding evolocumab (AMG 145) parent study), or less than 30 days since ending another investigational device or drug study(s),or receiving other investigational agent(s)

Where it is running

• Research Site — Birmingham, Alabama, United States
• Research Site — Chandler, Arizona, United States
• Research Site — Phoenix, Arizona, United States
• Research Site — Tucson, Arizona, United States
• Research Site — Little Rock, Arkansas, United States
• Research Site — Beverly Hills, California, United States
• Research Site — Carmichael, California, United States
• Research Site — Encinitas, California, United States
• Research Site — Huntington Beach, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Mission Viejo, California, United States
• Research Site — Newport Beach, California, United States
• Research Site — San Diego, California, United States
• Research Site — Santa Ana, California, United States
• Research Site — Santa Rosa, California, United States
• Research Site — Spring Valley, California, United States
• Research Site — Thousand Oaks, California, United States
• Research Site — Torrance, California, United States
• Research Site — Tustin, California, United States
• Research Site — Ventura, California, United States
• Research Site — Littleton, Colorado, United States
• Research Site — Daytona Beach, Florida, United States
• Research Site — DeLand, Florida, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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