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NCT01375764 Clinical Trial

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

Hyperlipidemia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01375764
Other study ID # 20090159
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date July 28, 2011
Est. completion date May 8, 2012

Study information
Verified date November 2022
Source Amgen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 160
Est. completion date May 8, 2012
Est. primary completion date May 8, 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Evolocumab
Administered by subcutaneous injection
Drug:
• Ezetimibe
Administered orally once a day
Other:
• Placebo to Evolocumab
Administered by subcutaneous injection

Locations
Country Name City State
Australia Research Site Camperdown New South Wales
Australia Research Site Melbourne Victoria
Australia Research Site Perth Western Australia
Australia Research Site Sydney New South Wales
Belgium Research Site Bruxelles
Belgium Research Site Uccle
Canada Research Site Lachine Quebec
Canada Research Site Saint John’s Newfoundland and Labrador
Canada Research Site St. John's Newfoundland and Labrador
Denmark Research Site Ballerup
Denmark Research Site Vejle
Finland Research Site Helsinki
Finland Research Site OYS
Spain Research Site Barcelona Cataluña
Spain Research Site Barcelona Cataluña
Spain Research Site L'Hospitalet de Llobregat Cataluña
Spain Research Site L'Hospitalet de Llobregat Cataluña
Spain Research Site Reus Cataluña
Spain Research Site Reus Cataluña
Spain Research Site Zaragoza Aragón
Spain Research Site Zaragoza Aragón
Sweden Research Site Göteborg
Sweden Research Site Göteborg
Sweden Research Site Lund
Sweden Research Site Stockholm
Sweden Research Site Stockholm
United States Research Site Akron Ohio
United States Research Site Anaheim California
United States Research Site Atlanta Georgia
United States Research Site Atlanta Georgia
United States Research Site Auburn Maine
United States Research Site Bristol Tennessee
United States Research Site Butte Montana
United States Research Site Chevy Chase Maryland
United States Research Site Cincinnati Ohio
United States Research Site Henderson Nevada
United States Research Site Las Vegas Nevada
United States Research Site Mission Viejo California
United States Research Site New York New York
United States Research Site Raleigh North Carolina
United States Research Site Savannah Georgia
United States Research Site Westlake Village California

Sponsors (1)
Lead Sponsor Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Denmark,  Finland,  Spain,  Sweden, 

References & 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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. Baseline and Week 12
Secondary 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. Baseline and Week 12
Secondary 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. Baseline and Week 12
Secondary 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. Baseline and Week 12
Secondary 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. Baseline and Week 12
Secondary 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. Baseline and Week 12
Secondary 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. Baseline and Week 12
Secondary 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. Baseline and Week 12
Secondary 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. Baseline and Week 12
Secondary 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. Baseline and Week 12
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