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

July 1, 2020 updated by: Amgen

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

307

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2015
        • Research Site
    • Queensland
      • Milton, Queensland, Australia, 4064
        • Research Site
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Research Site
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Research Site
  • Belgium
      • Brussels, Belgium, 1200
        • Research Site
      • Gent, Belgium, 9000
        • Research Site
      • La Louvière, Belgium, 7100
        • Research Site
  • Canada
    • Ontario
      • Newmarket, Ontario, Canada, L3Y 5G8
        • Research Site
    • Quebec
      • Lachine, Quebec, Canada, H8S 2E4
        • Research Site
      • Pointe-Claire, Quebec, Canada, H9R 3J1
        • Research Site
  • Denmark
      • Aalborg, Denmark, 9000
        • Research Site
      • Ballerup, Denmark, 2750
        • Research Site
      • Vejle, Denmark, 7100
        • Research Site
  • France
      • Lille Cedex, France, 59037
        • Research Site
      • Paris Cedex 13, France, 75651
        • Research Site
      • Vénissieux, France, 69200
        • Research Site
  • Germany
      • Bad Krozingen, Germany, 79189
        • Research Site
      • Dresden, Germany, 01307
        • Research Site
      • Heppenheim, Germany, 64646
        • Research Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • Research Site
      • New Territories, Hong Kong
        • Research Site
  • Netherlands
      • Alkmaar, Netherlands, 1815 JD
        • Research Site
      • Amsterdam, Netherlands, 1105 AZ
        • Research Site
      • Groningen, Netherlands, 9713 GZ
        • Research Site
  • Poland
      • Lodz, Poland, 90-368
        • Research Site
      • Warszawa, Poland, 04-730
        • Research Site
  • South Africa
    • Gauteng
      • Midrand, Gauteng, South Africa, 1685
        • Research Site
    • Western Cape
      • Observatory, Western Cape, South Africa, 7925
        • Research Site
      • Somerset West, Western Cape, South Africa, 7130
        • Research Site
  • Spain
    • Andalucía
      • Cordoba, Andalucía, Spain, 14004
        • Research Site
    • Aragón
      • Zaragoza, Aragón, Spain, 50009
        • Research Site
    • Cataluña
      • Reus, Cataluña, Spain, 43204
        • Research Site
  • Switzerland
      • Lugano, Switzerland, 6900
        • Research Site
      • Reinach, Switzerland, 4153
        • Research Site
  • United Kingdom
      • Liverpool, United Kingdom, L22 0LG
        • Research Site
      • London, United Kingdom, NW3 2QG
        • Research Site
      • Telford, United Kingdom, TF1 6TF
        • Research Site
      • West Bromwich, United Kingdom, B71 4HJ
        • Research Site
  • United States
    • California
      • Carmichael, California, United States, 95608
        • Research Site
      • Los Angeles, California, United States, 90048
        • Research Site
      • Mission Viejo, California, United States, 92691
        • Research Site
      • Thousand Oaks, California, United States, 91360
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30338
        • Research Site
      • Atlanta, Georgia, United States, 30342
        • Research Site
      • Savannah, Georgia, United States, 31406
        • Research Site
    • Maine
      • Auburn, Maine, United States, 04210
        • Research Site
    • Michigan
      • Traverse City, Michigan, United States, 49684
        • Research Site
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Research Site
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Research Site
      • Las Vegas, Nevada, United States, 89148
        • Research Site
      • Las Vegas, Nevada, United States, 89117
        • Research Site
    • New York
      • New York, New York, United States, 10029
        • Research Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
        • Research Site
    • Ohio
      • Akron, Ohio, United States, 44311
        • Research Site
      • Cincinnati, Ohio, United States, 45212
        • Research Site
      • Cleveland, Ohio, United States, 44195
        • Research Site
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Research Site
    • Texas
      • Houston, Texas, United States, 77030
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ezetimibe (Q2W)
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
Drug: Placebo to Evolocumab
Subcutaneous injection
Drug: Ezetimibe
Tablet for oral administration
Other Names:
  • Zetia
Active Comparator: Ezetimibe (QM)
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
Drug: Placebo to Evolocumab
Subcutaneous injection
Drug: Ezetimibe
Tablet for oral administration
Other Names:
  • Zetia
Experimental: Evolocumab Q2W
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
Biological: Evolocumab
Subcutaneous injection
Other Names:
  • Repatha
  • AMG 145
Drug: Placebo to Ezetimibe
Tablet for oral administration
Experimental: Evolocumab QM
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
Biological: Evolocumab
Subcutaneous injection
Other Names:
  • Repatha
  • AMG 145
Drug: Placebo to Ezetimibe
Tablet for oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Time Frame: Baseline and Weeks 10 and 12
Baseline and Weeks 10 and 12
Percent Change From Baseline in LDL-C at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Time Frame: Baseline and Weeks 10 and 12
Baseline and Weeks 10 and 12
Change From Baseline in LDL-C at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Percent Change From Baseline in Non-HDL-C at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12
Time Frame: Baseline and Weeks 10 and 12
Baseline and Weeks 10 and 12
Percent Change From Baseline in Apolipoprotein B at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
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
Baseline and Weeks 10 and 12
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 10 and 12
Time Frame: Baseline and Weeks 10 and 12
Baseline and Weeks 10 and 12
Percent Change From Baseline in Lipoprotein (a) at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12
Time Frame: Baseline and Weeks 10 and 12
Baseline and Weeks 10 and 12
Percent Change From Baseline in Triglycerides at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
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
Weeks 10 and 12
Percentage of Participants With LDL-C < 70 mg/dL (1.8 mmol/L) at Week 12
Time Frame: Week 12
Week 12
Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12
Time Frame: Baseline and Weeks 10 and 12
Baseline and Weeks 10 and 12
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
Baseline and Weeks 10 and 12
Percent Change From Baseline in the Total Cholesterol/High Density Lipoprotein Cholesterol Ratio at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
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
Baseline and Weeks 10 and 12
Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
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
Baseline and Weeks 10 and 12
Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2013

Primary Completion (Actual)

November 19, 2013

Study Completion (Actual)

November 19, 2013

Study Registration Dates

First Submitted

January 7, 2013

First Submitted That Met QC Criteria

January 8, 2013

First Posted (Estimate)

January 9, 2013

Study Record Updates

Last Update Posted (Actual)

July 20, 2020

Last Update Submitted That Met QC Criteria

July 1, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20110116
  • 2012-001364-30 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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