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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01375764
First received: June 16, 2011
Last updated: November 19, 2015
Last verified: November 2015

June 16, 2011
November 19, 2015
July 2011
May 2012   (final data collection date for primary outcome measure)
  • Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    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.
Percent change from baseline in LDL-C [ Time Frame: 12 week treatment duration ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01375764 on ClinicalTrials.gov Archive Site
  • Change From Baseline in LDL-C at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 week treatment duration ] [ Designated as safety issue: No ]
  • Percent change from baseline in ApoB at week 12 [ Time Frame: 12 week treatment duration ] [ Designated as safety issue: No ]
  • Percent change from baseline in the total cholesterol/HDL-C ratio at wk 12 [ Time Frame: 12 week treatment duration ] [ Designated as safety issue: No ]
  • Percent change from baseline in ApoB/ApoA1 ratio at week 12 [ Time Frame: 12 week treatment duration ] [ Designated as safety issue: No ]
  • Subject incidence of treatment emergent adverse events, serious adverse events, fatal adverse events, treatment related adverse events and adverse events leading to discontinuation of trial medication will be analyzed [ Time Frame: 12 week treatment duration ] [ Designated as safety issue: Yes ]
  • Absolute change from baseline in LDL-C at week 12 [ Time Frame: 12 week treatment duration ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hyperlipidemia
  • Biological: Evolocumab
    Administered by subcutaneous injection
    Other Names:
    • AMG 145
    • Repatha
  • Drug: Ezetimibe
    Administered orally once a day
    Other Name: Zetia
  • Other: Placebo to Evolocumab
    Administered by subcutaneous injection
  • Active Comparator: Ezetimibe
    Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
    Interventions:
    • Drug: Ezetimibe
    • Other: Placebo to Evolocumab
  • 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.
    Interventions:
    • Biological: Evolocumab
    • Drug: Ezetimibe
  • Experimental: Evolocumab 280 mg
    Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
    Intervention: Biological: Evolocumab
  • Experimental: Evolocumab 350 mg
    Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
    Intervention: Biological: Evolocumab
  • Experimental: Evolocumab 420 mg
    Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
    Intervention: Biological: Evolocumab
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
May 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Canada,   Denmark,   Finland,   Spain,   Sweden
 
NCT01375764
20090159
Yes
Not Provided
Not Provided
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP