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OpenTrials
Completed

NCT Number: NCT01652703

A Study to Evaluate Tolerability and Efficacy of Evolocumab (AMG 145) in Japanese Subjects

The primary objective is to evaluate the effect of 12 weeks of subcutaneous evolocumab every 2 weeks or every 4 weeks, compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) when used in addition to statin therapy in Japanese adults with hypercholesterolemia and high cardiovascular risk.

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Key information

Conditions

Hypercholesterolemia and High Risk for Cardiovascular Events Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Japanese adult, on statin, with or without ezetimibe, with stable dose(s) for at least 4 weeks, fasting LDL-C greater than or equal to 115 mg/dL (3.0 mmol/L), fasting triglycerides less than or equal to 400 mg/dL (4.5 mmol/L); Exclusion Criteria: New York Heart Association (NYHA) class III or IV, poorly controlled hypertension, recently diagnosed or poorly controlled type 2 diabetes, last known left ventricular ejection fraction < 30%, myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG), stroke, planned cardiac surgery or revascularization within 6 months of randomization, uncontrolled cardiac arrhythmia.

Treatment and study plan

Evolocumab

Biological

Administered by subcutaneous injection

Other names: AMG 145, Repatha

Placebo

Other

Administered by subcutaneous injection

Primary outcomes

  1. Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12

    Time frame: Baseline and Week 12

    LDL-C was measured using ultracentrifugation.

Secondary outcomes

  1. Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12

    Time frame: Baseline and Week 12

    LDL-C was measured using ultracentrifugation.

  2. Percentage of Participants With an LDL-C Response at Week 12

    Time frame: Week 12

    An LDL-C response was defined as LDL-C < 70 mg/dL (1.8 mmol/L) at Week 12. LDL-C was measured using ultracentrifugation.

  3. Percent Change From Baseline to Week 12 in Non-HDL-C

    Time frame: Baseline and Week 12

  4. Percent Change From Baseline to Week 12 in Apolipoprotein B

    Time frame: Baseline and Week 12

  5. Percent Change From Baseline to Week 12 in VLDL-C

    Time frame: Baseline and Week 12

  6. Percent Change From Baseline to Week 12 in Total Cholesterol/HDL-C Ratio

    Time frame: Baseline and Week 12

  7. Percent Change From Baseline to Week 12 in Apolipoprotein B/Apolipoprotein A-1 Ratio

    Time frame: Baseline and Week 12

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Tolerability and Efficacy of AMG 145 on LDL-C in Combination With Stable Statin Therapy in Japanese Subjects With Hypercholesterolemia and High Cardiovascular Risk

Acronym: AMG145

Important dates

Study start
2012
Primary completion
2013
First posted
Jul 30, 2012
Registry last updated
Nov 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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