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: January 24, 2014
Last verified: January 2014

June 16, 2011
January 24, 2014
June 2011
May 2012   (final data collection date for primary outcome measure)
Percent change from baseline in low density lipoprotein cholesterol [ Time Frame: 12 week treatment duration ] [ Designated as safety issue: No ]
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
  • Absolute change from baseline in low density lipoprotein cholesterol at week 12 [ Time Frame: 12 week treatment duration ] [ Designated as safety issue: No ]
  • Percent change from baseline in non-high density lipoprotein cholesterol at week 12 [ Time Frame: 12 week treatment duration ] [ Designated as safety issue: No ]
  • Percent change from baseline in Apolipoprotein B at week 12 [ Time Frame: 12 week treatment duration ] [ Designated as safety issue: No ]
  • Percent change from baseline in the total cholesterol/high density lipoprotein cholesterol ratio at week 12 [ Time Frame: 12 week treatment duration ] [ Designated as safety issue: No ]
  • Percent change from baseline in Apolipoprotein B/Apolipoprotein A1 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 ]
  • 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 ]
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 hypothesis is that a dose of evolocumab (AMG 145) every 4-weeks (Q4W) will be well tolerated and will result in greater lowering of Low Density Lipoprotein-Cholesterol at week 12 than ezetimibe in hypercholesterolemic subjects unable to tolerate an effective dose of a HMG-CoA reductase inhibitor.

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 (AMG 145)
    Patients will receive evolocumab (AMG 145) every 4 weeks
  • Other: Ezetimibe
    Patients will take Ezetimibe once a day
  • Other: Placebo
    Patients will receive placebo every 4 weeks. All Patients at screening will participate in the placebo run-in
  • Experimental: Group 4 with Ezetimibe
    Dose 3 of subcutaneous evolocumab (AMG 145). Oral Ezetimibe once a day
    Interventions:
    • Biological: evolocumab (AMG 145)
    • Other: Ezetimibe
  • Experimental: Group 1
    Dose 1 of subcutaneous evolocumab (AMG 145)
    Intervention: Biological: evolocumab (AMG 145)
  • Experimental: Group 2
    Dose 2 of subcutaneous evolocumab (AMG 145)
    Intervention: Biological: evolocumab (AMG 145)
  • Experimental: Group 3
    Dose 3 of subcutaneous evolocumab (AMG 145)
    Intervention: Biological: evolocumab (AMG 145)
  • Experimental: Group 5
    Oral Ezetimibe & subcutaneous Placebo
    Interventions:
    • Other: Ezetimibe
    • Other: Placebo
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
June 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:

  • 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
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Canada,   Denmark,   Finland,   Spain,   Sweden
 
NCT01375764
20090159
Yes
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
January 2014

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