Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects
GAUSS
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
1 other identifier
interventional
160
8 countries
42
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2011
Shorter than P25 for phase_2
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2011
CompletedFirst Posted
Study publicly available on registry
June 17, 2011
CompletedStudy Start
First participant enrolled
July 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 8, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 8, 2012
CompletedResults Posted
Study results publicly available
December 23, 2015
CompletedNovember 7, 2022
November 1, 2022
10 months
June 16, 2011
September 2, 2015
November 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at 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.
Baseline and Week 12
Percent Change From Baseline in LDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
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.
Baseline and Week 12
Secondary Outcomes (10)
Change From Baseline in LDL-C at Week 12
Baseline and Week 12
Change From Baseline in LDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
Baseline and Week 12
Percent Change From Baseline in Non-HDL-C at Week 12
Baseline and Week 12
Percent Change From Baseline in Non-HDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
Baseline and Week 12
Percent Change From Baseline in Apolipoprotein B at Week 12
Baseline and Week 12
- +5 more secondary outcomes
Study Arms (5)
Ezetimibe
ACTIVE COMPARATORParticipants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
Evolocumab + Ezetimibe
EXPERIMENTALParticipants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
Evolocumab 280 mg
EXPERIMENTALParticipants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Evolocumab 350 mg
EXPERIMENTALParticipants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Evolocumab 420 mg
EXPERIMENTALParticipants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Interventions
Administered by subcutaneous injection
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (42)
Research Site
Anaheim, California, 92801, United States
Research Site
Mission Viejo, California, 92691, United States
Research Site
Westlake Village, California, 91361, United States
Research Site
Atlanta, Georgia, 30338, United States
Research Site
Atlanta, Georgia, 30342, United States
Research Site
Savannah, Georgia, 31406, United States
Research Site
Auburn, Maine, 04210, United States
Research Site
Chevy Chase, Maryland, 20815, United States
Research Site
Butte, Montana, 59701, United States
Research Site
Henderson, Nevada, 89052, United States
Research Site
Las Vegas, Nevada, 89117, United States
Research Site
New York, New York, 10029, United States
Research Site
Raleigh, North Carolina, 27609, United States
Research Site
Akron, Ohio, 44311, United States
Research Site
Cincinnati, Ohio, 45212, United States
Research Site
Bristol, Tennessee, 37620, United States
Research Site
Camperdown, New South Wales, 2015, Australia
Research Site
Sydney, New South Wales, 2022, Australia
Research Site
Melbourne, Victoria, 3004, Australia
Research Site
Perth, Western Australia, 6000, Australia
Research Site
Brussels, 1200, Belgium
Research Site
Uccle, 1180, Belgium
Research Site
Saint John’s, Newfoundland and Labrador, A1A 3R5, Canada
Research Site
St. John's, Newfoundland and Labrador, A1A 3R5, Canada
Research Site
Lachine, Quebec, H8S 2E4, Canada
Research Site
Ballerup Municipality, 2750, Denmark
Research Site
Vejle, 7100, Denmark
Research Site
Helsinki, 00029, Finland
Research Site
OYS, 90029, Finland
Research Site
Zaragoza, Aragon, 50009, Spain
Research Site
Zaragoza, Aragón, 50009, Spain
Research Site
Barcelona, Catalonia, 08036, Spain
Research Site
L'Hospitalet de Llobregat, Catalonia, 08907, Spain
Research Site
Reus, Catalonia, 43204, Spain
Research Site
Barcelona, Cataluña, 08036, Spain
Research Site
L'Hospitalet de Llobregat, Cataluña, 08907, Spain
Research Site
Reus, Cataluña, 43204, Spain
Research Site
Göteborg, 411 36, Sweden
Research Site
Gothenburg, 411 36, Sweden
Research Site
Lund, 222 21, Sweden
Research Site
Stockholm, 111 35, Sweden
Research Site
Stockholm, 141 86, Sweden
Related Publications (1)
Sullivan D, Olsson AG, Scott R, Kim JB, Xue A, Gebski V, Wasserman SM, Stein EA. Effect of a monoclonal antibody to PCSK9 on low-density lipoprotein cholesterol levels in statin-intolerant patients: the GAUSS randomized trial. JAMA. 2012 Dec 19;308(23):2497-506. doi: 10.1001/jama.2012.25790.
PMID: 23128163BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2011
First Posted
June 17, 2011
Study Start
July 28, 2011
Primary Completion
May 8, 2012
Study Completion
May 8, 2012
Last Updated
November 7, 2022
Results First Posted
December 23, 2015
Record last verified: 2022-11