Reduction of LDL-C With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study-2

Completed · Phase 3 · Has a placebo group

Conditions studied: Hyperlipidemia

In brief

The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneously once every 2 weeks (Q2W) and once monthly (QM), compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with heterozygous familial hypercholesterolemia (HeFH).

Key facts

Study ID

NCT01763918

Run by

Amgen

People needed

331

Starts

2013-02-07

Expected to finish

2013-12-19

Last updated by the study team

2019-06-17

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female ≥ 18 to ≤ 80 years of age
• Diagnosis of heterozygous familial hypercholesterolemia
• On a stable dose of an approved statin and lipid regulating medication
• Fasting LDL-C ≥ 100 mg/dL (2.6 mmol/L)
• Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)

You may not qualify if…

• Homozygous familial hypercholesterolemia
• LDL or plasma apheresis
• New York Heart Association (NYHA) III or IV heart failure
• Uncontrolled cardiac arrhythmia
• Uncontrolled hypertension
• Type 1 diabetes, poorly controlled type 2 diabetes
• Uncontrolled hypothyroidism or hyperthyroidism

Where it is running

• Research Site — Scottsdale, Arizona, United States
• Research Site — Cincinnati, Ohio, United States
• Research Site — Camperdown, New South Wales, Australia
• Research Site — Perth, Western Australia, Australia
• Research Site — Vancouver, British Columbia, Canada
• Research Site — London, Ontario, Canada
• Research Site — Chicoutimi, Quebec, Canada
• Research Site — Montreal, Quebec, Canada
• Research Site — Montreal, Quebec, Canada
• Research Site — Bron, France
• Research Site — Nantes, France
• Research Site — Paris, France
• Research Site — Cologne, Germany
• Research Site — New Territories, Hong Kong
• Research Site — Amersfoort, Netherlands
• Research Site — Amsterdam, Netherlands
• Research Site — Amsterdam, Netherlands
• Research Site — Gouda, Netherlands
• Research Site — Groningen, Netherlands
• Research Site — Hoorn, Netherlands
• Research Site — Tilburg, Netherlands
• Research Site — Utrecht, Netherlands
• Research Site — Christchurch, New Zealand
• Research Site — Oslo, Norway
• Research Site — Johannesburg, Gauteng, South Africa

Full record on ClinicalTrials.gov

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