Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01375764
Recruitment Status : Completed
First Posted : June 17, 2011
Results First Posted : December 23, 2015
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with hypercholesterolemia unable to tolerate an effective dose of a statin.

Condition or disease Intervention/treatment Phase
Hyperlipidemia Biological: Evolocumab Drug: Ezetimibe Other: Placebo to Evolocumab Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter Study to Evaluate Tolerability and Efficacy of AMG 145 on LDL-C, Compared With Ezetimibe, in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase Inhibitor
Actual Study Start Date : July 28, 2011
Actual Primary Completion Date : May 8, 2012
Actual Study Completion Date : May 8, 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Ezetimibe
Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
 Drug: Ezetimibe
Administered orally once a day
Other Name: Zetia

Other: Placebo to Evolocumab
Administered by subcutaneous injection
Experimental: Evolocumab + Ezetimibe
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
 Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • AMG 145
  • Repatha

Drug: Ezetimibe
Administered orally once a day
Other Name: Zetia
Experimental: Evolocumab 280 mg
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
 Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • AMG 145
  • Repatha
Experimental: Evolocumab 350 mg
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
 Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • AMG 145
  • Repatha
Experimental: Evolocumab 420 mg
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
 Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • AMG 145
  • Repatha


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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. Least squares (LS) means are based off an analysis of covariance (ANCOVA) model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.

  2. Percent Change From Baseline in LDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe [ Time Frame: Baseline and Week 12 ]
    LDL-C was measured using ultracentrifugation. LS means are based off an ANCOVA model which includes treatment group (evolocumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.


Secondary Outcome Measures :
  1. Change From Baseline in LDL-C at Week 12 [ Time Frame: Baseline and Week 12 ]
    LDL-C was measured using ultracentrifugation. LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.

  2. Change From Baseline in LDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe [ Time Frame: Baseline and Week 12 ]
    LDL-C was measured using ultracentrifugation. LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.

  3. Percent Change From Baseline in Non-HDL-C at Week 12 [ Time Frame: Baseline and Week 12 ]
    LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.

  4. Percent Change From Baseline in Non-HDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe [ Time Frame: Baseline and Week 12 ]
    LS means are based off an ANCOVA model which includes treatment group (evolocumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.

  5. Percent Change From Baseline in Apolipoprotein B at Week 12 [ Time Frame: Baseline and Week 12 ]
    LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.

  6. Percent Change From Baseline in Apolipoprotein B at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe [ Time Frame: Baseline and Week 12 ]
    LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe) and stratification factors as covariates.

  7. Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12 [ Time Frame: Baseline and Week 12 ]
    LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.

  8. Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe [ Time Frame: Baseline and Week 12 ]
    LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.

  9. Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 [ Time Frame: Baseline and Week 12 ]
    LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.

  10. Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe [ Time Frame: Baseline and Week 12 ]
    LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female ≥ 18 to ≤ 75 years of age
  • On a statin or a low dose statin with stable dose for at least 4 weeks
  • Lipid lowering therapy has been stable prior to enrollment
  • Fasting triglycerides must be < 400 mg/dL.
  • Subject not at LDL-C goal

Exclusion Criteria:

  • New York Heart Association (NYHA) III or IV heart failure or known left ventricular ejection fraction < 30%
  • Uncontrolled cardiac arrhythmia
  • Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization
  • Type 1 diabetes or newly diagnosed type 2 diabetes (HbA1c > 8.5%)
  • Uncontrolled hypertension
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01375764


Locations
Layout table for location information
United States, California
Research Site
Anaheim, California, United States, 92801
Research Site
Mission Viejo, California, United States, 92691
Research Site
Westlake Village, California, United States, 91361
United States, Georgia
Research Site
Atlanta, Georgia, United States, 30338
Research Site
Atlanta, Georgia, United States, 30342
Research Site
Savannah, Georgia, United States, 31406
United States, Maine
Research Site
Auburn, Maine, United States, 04210
United States, Maryland
Research Site
Chevy Chase, Maryland, United States, 20815
United States, Montana
Research Site
Butte, Montana, United States, 59701
United States, Nevada
Research Site
Henderson, Nevada, United States, 89052
Research Site
Las Vegas, Nevada, United States, 89117
United States, New York
Research Site
New York, New York, United States, 10029
United States, North Carolina
Research Site
Raleigh, North Carolina, United States, 27609
United States, Ohio
Research Site
Akron, Ohio, United States, 44311
Research Site
Cincinnati, Ohio, United States, 45212
United States, Tennessee
Research Site
Bristol, Tennessee, United States, 37620
Australia, New South Wales
Research Site
Camperdown, New South Wales, Australia, 2015
Research Site
Sydney, New South Wales, Australia, 2022
Australia, Victoria
Research Site
Melbourne, Victoria, Australia, 3004
Australia, Western Australia
Research Site
Perth, Western Australia, Australia, 6000
Belgium
Research Site
Bruxelles, Belgium, 1200
Research Site
Uccle, Belgium, 1180
Canada, Newfoundland and Labrador
Research Site
Saint John’s, Newfoundland and Labrador, Canada, A1A 3R5
Research Site
St. John's, Newfoundland and Labrador, Canada, A1A 3R5
Canada, Quebec
Research Site
Lachine, Quebec, Canada, H8S 2E4
Denmark
Research Site
Ballerup, Denmark, 2750
Research Site
Vejle, Denmark, 7100
Finland
Research Site
Helsinki, Finland, 00029
Research Site
OYS, Finland, 90029
Spain
Research Site
Zaragoza, Aragón, Spain, 50009
Research Site
Zaragoza, Aragón, Spain, 50009
Research Site
Barcelona, Cataluña, Spain, 08036
Research Site
L'Hospitalet de Llobregat, Cataluña, Spain, 08907
Research Site
Reus, Cataluña, Spain, 43204
Research Site
Barcelona, Cataluña, Spain, 08036
Research Site
L'Hospitalet de Llobregat, Cataluña, Spain, 08907
Research Site
Reus, Cataluña, Spain, 43204
Sweden
Research Site
Göteborg, Sweden, 411 36
Research Site
Göteborg, Sweden, 411 36
Research Site
Lund, Sweden, 222 21
Research Site
Stockholm, Sweden, 111 35
Research Site
Stockholm, Sweden, 141 86
Sponsors and Collaborators
Amgen
Investigators
Layout table for investigator information
Study Director: MD Amgen
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications:

Layout table for additonal information
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01375764    
Other Study ID Numbers: 20090159
First Posted: June 17, 2011    Key Record Dates
Results First Posted: December 23, 2015
Last Update Posted: January 5, 2021
Last Verified: January 2021
Keywords provided by Amgen:
Proprotein convertase subtilisin/kexin type 9 (PCSK9)
Cholesterol
High Cholesterol
Raised Cholesterol
 Elevated Cholesterol
Statin intolerant
Hypercholesterolemia
Additional relevant MeSH terms:
Layout table for MeSH terms
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Ezetimibe
Evolocumab
Antibodies, Monoclonal
 Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Immunologic Factors
Physiological Effects of Drugs