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Study Complete
Sponsor ID
20090159

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

Sponsor ID
20090159
Clinicaltrials.gov ID
NCT01375764
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 2
Product
Evolocumab
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
160
Additional Study Details

Protocol Summary

Primary Outcome Measures

Percent change from baseline in low density lipoprotein cholesterol

Timeframe: 12 week treatment duration

Secondary Outcome Measures

Absolute change from baseline in low density lipoprotein cholesterol at week 12

Timeframe: 12 week treatment duration

Percent change from baseline in non-high density lipoprotein cholesterol at week 12

Timeframe: 12 week treatment duration

Percent change from baseline in Apolipoprotein B at week 12

Timeframe: 12 week treatment duration

Percent change from baseline in the total cholesterol/high density lipoprotein cholesterol ratio at week 12

Timeframe: 12 week treatment duration

Percent change from baseline in Apolipoprotein B/Apolipoprotein A1 ratio at week 12

Timeframe: 12 week treatment duration

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Camperdown, NSW, Australia, 2015
Status
Recruiting
Location
Research Site
Melbourne, VIC, Australia, 3004
Status
Recruiting
Location
Research Site
Sydney, NSW, Australia, 2022
Status
Recruiting
Location
Research Site
Perth, WA, Australia, 6000
Status
Recruiting
Location
Research Site
Uccle, Belgium, 1180
Status
Recruiting
Location
Research Site
Bruxelles, Belgium, 1200
Status
Recruiting
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Study Info
Age
18 - 75 Years
Condition
  • Cholesterol
    • Sex
    All
    Trial Dates
    Jul 2011 - May 2012
    Inclusion and Exclusion 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