Clinical trial NCT01375764: Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperlipidemia
Keywords: Proprotein convertase subtilisin/kexin type 9 (PCSK9)
Cholesterol
High Cholesterol
Raised Cholesterol
Elevated Cholesterol
Statin intolerant
Hypercholesterolemia
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2011-06-17
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
timeFrame: Baseline and Week 12
measure: Percent Change From Baseline in LDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change From Baseline in LDL-C at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in LDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
timeFrame: Baseline and Week 12
measure: Percent Change From Baseline in Non-HDL-C at Week 12
timeFrame: Baseline and Week 12
measure: Percent Change From Baseline in Non-HDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
timeFrame: Baseline and Week 12
measure: Percent Change From Baseline in Apolipoprotein B at Week 12
timeFrame: Baseline and Week 12
measure: Percent Change From Baseline in Apolipoprotein B at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
timeFrame: Baseline and Week 12
measure: Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12
timeFrame: Baseline and Week 12
measure: Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
timeFrame: Baseline and Week 12
measure: Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12
timeFrame: Baseline and Week 12
measure: Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Research Site
state: California
city: Mission Viejo
country: United States
facility: Research Site
state: California
city: Westlake Village
country: United States
facility: Research Site
state: California
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Savannah
country: United States
facility: Research Site
state: Georgia
city: Auburn
country: United States
facility: Research Site
state: Maine
city: Chevy Chase
country: United States
facility: Research Site
state: Maryland
city: Butte
country: United States
facility: Research Site
state: Montana
city: Henderson
country: United States
facility: Research Site
state: Nevada
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
city: New York
country: United States
facility: Research Site
state: New York
city: Raleigh
country: United States
facility: Research Site
state: North Carolina
city: Akron
country: United States
facility: Research Site
state: Ohio
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Bristol
country: United States
facility: Research Site
state: Tennessee
city: Camperdown
country: Australia
facility: Research Site
state: New South Wales
city: Sydney
country: Australia
facility: Research Site
state: New South Wales
city: Melbourne
country: Australia
facility: Research Site
state: Victoria
city: Perth
country: Australia
facility: Research Site
state: Western Australia
city: Bruxelles
country: Belgium
facility: Research Site
city: Uccle
country: Belgium
facility: Research Site
city: Saint Johnâ€™s
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Lachine
country: Canada
facility: Research Site
state: Quebec
city: Ballerup
country: Denmark
facility: Research Site
city: Vejle
country: Denmark
facility: Research Site
city: Helsinki
country: Finland
facility: Research Site
city: OYS
country: Finland
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
state: AragÃ³n
city: Zaragoza
country: Spain
facility: Research Site
state: Aragón
city: Barcelona
country: Spain
facility: Research Site
state: CataluÃ±a
city: L'Hospitalet de Llobregat
country: Spain
facility: Research Site
state: CataluÃ±a
city: Reus
country: Spain
facility: Research Site
state: CataluÃ±a
city: Barcelona
country: Spain
facility: Research Site
state: Cataluña
city: L'Hospitalet de Llobregat
country: Spain
facility: Research Site
state: Cataluña
city: Reus
country: Spain
facility: Research Site
state: Cataluña
city: GÃ¶teborg
country: Sweden
facility: Research Site
city: Göteborg
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
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.