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

Primary Purpose

Hyperlipidemia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Evolocumab
Ezetimibe
Placebo to Evolocumab
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipidemia focused on measuring Proprotein convertase subtilisin/kexin type 9 (PCSK9), Cholesterol, High Cholesterol, Raised Cholesterol, Elevated Cholesterol, Statin intolerant, Hypercholesterolemia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Ezetimibe

Evolocumab + Ezetimibe

Evolocumab 280 mg

Evolocumab 350 mg

Evolocumab 420 mg

Arm Description

Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.

Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.

Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.

Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.

Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Change From Baseline in LDL-C at 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.
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 (evoloumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.
Percent Change From Baseline in Non-HDL-C at 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.
Percent Change From Baseline in Non-HDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
LS means are based off an ANCOVA model which includes treatment group (evolocumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.
Percent Change From Baseline in Apolipoprotein B at 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.
Percent Change From Baseline in Apolipoprotein B at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe) and stratification factors as covariates.
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at 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.
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at 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.
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.

Full Information

First Posted
June 16, 2011
Last Updated
November 4, 2022
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT01375764
Brief Title
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects
Acronym
GAUSS
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
July 28, 2011 (Actual)
Primary Completion Date
May 8, 2012 (Actual)
Study Completion Date
May 8, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia
Keywords
Proprotein convertase subtilisin/kexin type 9 (PCSK9), Cholesterol, High Cholesterol, Raised Cholesterol, Elevated Cholesterol, Statin intolerant, Hypercholesterolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ezetimibe
Arm Type
Active Comparator
Arm Description
Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
Arm Title
Evolocumab + Ezetimibe
Arm Type
Experimental
Arm Description
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
Arm Title
Evolocumab 280 mg
Arm Type
Experimental
Arm Description
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Arm Title
Evolocumab 350 mg
Arm Type
Experimental
Arm Description
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Arm Title
Evolocumab 420 mg
Arm Type
Experimental
Arm Description
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Intervention Type
Biological
Intervention Name(s)
Evolocumab
Other Intervention Name(s)
AMG 145, Repatha
Intervention Description
Administered by subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Ezetimibe
Other Intervention Name(s)
Zetia
Intervention Description
Administered orally once a day
Intervention Type
Other
Intervention Name(s)
Placebo to Evolocumab
Intervention Description
Administered by subcutaneous injection
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
Description
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.
Time Frame
Baseline and Week 12
Title
Percent Change From Baseline in LDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
Description
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.
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in LDL-C at Week 12
Description
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.
Time Frame
Baseline and Week 12
Title
Change From Baseline in LDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
Description
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.
Time Frame
Baseline and Week 12
Title
Percent Change From Baseline in Non-HDL-C at Week 12
Description
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.
Time Frame
Baseline and Week 12
Title
Percent Change From Baseline in Non-HDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
Description
LS means are based off an ANCOVA model which includes treatment group (evolocumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.
Time Frame
Baseline and Week 12
Title
Percent Change From Baseline in Apolipoprotein B at Week 12
Description
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.
Time Frame
Baseline and Week 12
Title
Percent Change From Baseline in Apolipoprotein B at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
Description
LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe) and stratification factors as covariates.
Time Frame
Baseline and Week 12
Title
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12
Description
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.
Time Frame
Baseline and Week 12
Title
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
Description
LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.
Time Frame
Baseline and Week 12
Title
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12
Description
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.
Time Frame
Baseline and Week 12
Title
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
Description
LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.
Time Frame
Baseline and Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Research Site
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Research Site
City
Westlake Village
State/Province
California
ZIP/Postal Code
91361
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Research Site
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Research Site
City
Auburn
State/Province
Maine
ZIP/Postal Code
04210
Country
United States
Facility Name
Research Site
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Research Site
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Research Site
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89117
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Research Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Research Site
City
Akron
State/Province
Ohio
ZIP/Postal Code
44311
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Research Site
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Research Site
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2015
Country
Australia
Facility Name
Research Site
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2022
Country
Australia
Facility Name
Research Site
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Research Site
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
Research Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Research Site
City
Uccle
ZIP/Postal Code
1180
Country
Belgium
Facility Name
Research Site
City
Saint John’s
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1A 3R5
Country
Canada
Facility Name
Research Site
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1A 3R5
Country
Canada
Facility Name
Research Site
City
Lachine
State/Province
Quebec
ZIP/Postal Code
H8S 2E4
Country
Canada
Facility Name
Research Site
City
Ballerup
ZIP/Postal Code
2750
Country
Denmark
Facility Name
Research Site
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Facility Name
Research Site
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
Research Site
City
OYS
ZIP/Postal Code
90029
Country
Finland
Facility Name
Research Site
City
Zaragoza
State/Province
Aragón
ZIP/Postal Code
50009
Country
Spain
Facility Name
Research Site
City
Zaragoza
State/Province
Aragón
ZIP/Postal Code
50009
Country
Spain
Facility Name
Research Site
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08036
Country
Spain
Facility Name
Research Site
City
L'Hospitalet de Llobregat
State/Province
Cataluña
ZIP/Postal Code
08907
Country
Spain
Facility Name
Research Site
City
Reus
State/Province
Cataluña
ZIP/Postal Code
43204
Country
Spain
Facility Name
Research Site
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08036
Country
Spain
Facility Name
Research Site
City
L'Hospitalet de Llobregat
State/Province
Cataluña
ZIP/Postal Code
08907
Country
Spain
Facility Name
Research Site
City
Reus
State/Province
Cataluña
ZIP/Postal Code
43204
Country
Spain
Facility Name
Research Site
City
Göteborg
ZIP/Postal Code
411 36
Country
Sweden
Facility Name
Research Site
City
Göteborg
ZIP/Postal Code
411 36
Country
Sweden
Facility Name
Research Site
City
Lund
ZIP/Postal Code
222 21
Country
Sweden
Facility Name
Research Site
City
Stockholm
ZIP/Postal Code
111 35
Country
Sweden
Facility Name
Research Site
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
23128163
Citation
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.
Results Reference
background
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

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

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