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OpenTrials
Completed

NCT Number: NCT01763905

Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects -2

The primary objective was to evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab every 2 weeks (Q2W) and monthly (QM), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in hypercholesterolemic adults unable to tolerate an effective dose of a statin (HMG-CoA (5-hydroxy-3-methylglutaryl-coenzyme A) reductase inhibitors).

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Key information

Conditions

Hyperlipidemia Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Camperdown, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female ≥ 18 to ≤ 80 years of age
  • Not on a statin or on a low dose statin with stable dose for at least 4 weeks
  • History of intolerance to at least 2 statins
  • Subject not at LDL-C goal
  • Lipid lowering therapy has been stable prior to enrolment for at least 4 weeks.
  • Fasting triglycerides ≤ 400 mg/dL

Exclusion criteria

  • 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

Treatment and study plan

Evolocumab

Biological

Subcutaneous injection

Other names: AMG 145, Repatha

Placebo to Evolocumab

Drug

Subcutaneous injection

ezetimibe

Drug

Tablet for oral administration

Other names: Zetia

Placebo to Ezetimibe

Drug

Tablet for oral administration

Primary outcomes

  1. Percent Change From Baseline in LDL-C at Week 12

    Time frame: Baseline and Week 12

  2. Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12

    Time frame: Baseline and Weeks 10 and 12

Secondary outcomes

  1. Change From Baseline in LDL-C at the Mean of Weeks 10 and 12

    Time frame: Baseline and Weeks 10 and 12

  2. Change From Baseline in LDL-C at Week 12

    Time frame: Baseline and Week 12

  3. Percentage of Participants With Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL (1.8 mmol/L)

    Time frame: Weeks 10 and 12

  4. Percentage of Participants With LDL-C < 70 mg/dL (1.8 mmol/L) at Week 12

    Time frame: Week 12

  5. Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12

    Time frame: Baseline and Weeks 10 and 12

  6. Percent Change From Baseline in Non-HDL-C at Week 12

    Time frame: Baseline and Week 12

  7. Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12

    Time frame: Baseline and Weeks 10 and 12

  8. Percent Change From Baseline in Apolipoprotein B at Week 12

    Time frame: Baseline and Week 12

  9. Percent Change From Baseline in the Total Cholesterol/High Density Lipoprotein Cholesterol Ratio at the Mean of Weeks 10 and 12

    Time frame: Baseline and Weeks 10 and 12

  10. Percent Change From Baseline in the Total Cholesterol/High Density Lipoprotein Cholesterol Ratio at Week 12

    Time frame: Baseline and Week 12

  11. Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12

    Time frame: Baseline and Weeks 10 and 12

  12. Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12

    Time frame: Baseline and Week 12

  13. Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 10 and 12

    Time frame: Baseline and Weeks 10 and 12

  14. Percent Change From Baseline in Lipoprotein (a) at Week 12

    Time frame: Baseline and Week 12

  15. Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12

    Time frame: Baseline and Weeks 10 and 12

  16. Percent Change From Baseline in Triglycerides at Week 12

    Time frame: Baseline and Week 12

  17. Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at the Mean of Weeks 10 and 12

    Time frame: Baseline and Weeks 10 and 12

  18. Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 12

    Time frame: Baseline and Week 12

  19. Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol at the Mean of Weeks 10 and 12

    Time frame: Baseline and Weeks 10 and 12

  20. Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol at Week 12

    Time frame: Baseline and Week 12

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Double-blind, Randomized, Multicenter Study to Evaluate Safety and Efficacy of AMG 145, Compared With Ezetimibe, in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase Inhibitor

Acronym: GAUSS-2

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jan 9, 2013
Registry last updated
Jul 20, 2020

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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