Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects -2 (GAUSS-2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01763905
First received: January 7, 2013
Last updated: November 18, 2015
Last verified: November 2015
  Purpose
The primary objective was to evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab every 2 weeks (Q2W) and monthly (QM), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in hypercholesterolemic adults unable to tolerate an effective dose of a statin (HMG-CoA (5-hydroxy-3-methylglutaryl-coenzyme A) reductase inhibitors).

Condition Intervention Phase
Hyperlipidemia
Biological: Evolocumab
Drug: Placebo to Evolocumab
Drug: Ezetimibe
Drug: Placebo to Ezetimibe
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Multicenter Study to Evaluate Safety and Efficacy of AMG 145, Compared With Ezetimibe, in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase Inhibitor

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Percent Change From Baseline in LDL-C at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and Weeks 10 and 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and Weeks 10 and 12 ] [ Designated as safety issue: No ]
  • Change From Baseline in LDL-C at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL (1.8 mmol/L) [ Time Frame: Weeks 10 and 12 ] [ Designated as safety issue: No ]
  • Percentage of Participants With LDL-C < 70 mg/dL (1.8 mmol/L) at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and Weeks 10 and 12 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Non-HDL-C at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and Weeks 10 and 12 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Apolipoprotein B at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in the Total Cholesterol/High Density Lipoprotein Cholesterol Ratio at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and Weeks 10 and 12 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in the Total Cholesterol/High Density Lipoprotein Cholesterol Ratio at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and Weeks 10 and 12 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and Weeks 10 and 12 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Lipoprotein (a) at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and Weeks 10 and 12 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Triglycerides at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and Weeks 10 and 12 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and Weeks 10 and 12 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]

Enrollment: 307
Study Start Date: January 2013
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ezetimibe (Q2W)
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
Drug: Placebo to Evolocumab
Subcutaneous injection
Drug: Ezetimibe
Tablet for oral administration
Other Name: Zetia
Active Comparator: Ezetimibe (QM)
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
Drug: Placebo to Evolocumab
Subcutaneous injection
Drug: Ezetimibe
Tablet for oral administration
Other Name: Zetia
Experimental: Evolocumab Q2W
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
Biological: Evolocumab
Subcutaneous injection
Other Names:
  • AMG 145
  • Repatha
Drug: Placebo to Ezetimibe
Tablet for oral administration
Experimental: Evolocumab QM
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
Biological: Evolocumab
Subcutaneous injection
Other Names:
  • AMG 145
  • Repatha
Drug: Placebo to Ezetimibe
Tablet for oral administration

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female ≥ 18 to ≤ 80 years of age
  • Not on a statin or on a low dose statin with stable dose for at least 4 weeks
  • History of intolerance to at least 2 statins
  • Subject not at LDL-C goal
  • Lipid lowering therapy has been stable prior to enrolment for at least 4 weeks.
  • Fasting triglycerides ≤ 400 mg/dL

Exclusion Criteria:

  • New York Heart Association (NYHA) III or IV heart failure
  • Uncontrolled cardiac arrhythmia
  • Uncontrolled hypertension
  • Type 1 diabetes, poorly controlled type 2 diabetes
  • Uncontrolled hypothyroidism or hyperthyroidism
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01763905

  Hide Study Locations
Locations
United States, California
Research Site
Carmichael, California, United States, 95608
Research Site
Los Angeles, California, United States, 90048
Research Site
Mission Viejo, California, United States, 92691
Research Site
Thousand Oaks, California, United States, 91360
United States, Georgia
Research Site
Atlanta, Georgia, United States, 30338
Research Site
Atlanta, Georgia, United States, 30342
Research Site
Savannah, Georgia, United States, 31406
United States, Maine
Research Site
Auburn, Maine, United States, 04210
United States, Michigan
Research Site
Traverse City, Michigan, United States, 49684
United States, Missouri
Research Site
St. Louis, Missouri, United States, 63110
United States, Nevada
Research Site
Henderson, Nevada, United States, 89052
Research Site
Las Vegas, Nevada, United States, 89117
Research Site
Las Vegas, Nevada, United States, 89148
United States, New York
Research Site
New York, New York, United States, 10029
United States, North Carolina
Research Site
Raleigh, North Carolina, United States, 27609
United States, Ohio
Research Site
Akron, Ohio, United States, 44311
Research Site
Cincinnati, Ohio, United States, 45212
Research Site
Cleveland, Ohio, United States, 44195
United States, Oklahoma
Research Site
Norman, Oklahoma, United States, 73069
United States, Texas
Research Site
Houston, Texas, United States, 77030
Australia, New South Wales
Research Site
Camperdown, New South Wales, Australia, 2015
Australia, Queensland
Research Site
Milton, Queensland, Australia, 4064
Australia, Victoria
Research Site
Melbourne, Victoria, Australia, 3004
Australia, Western Australia
Research Site
Perth, Western Australia, Australia, 6000
Belgium
Research Site
Brussels, Belgium, 1200
Research Site
Gent, Belgium, 9000
Research Site
La Louvière, Belgium, 7100
Canada, Ontario
Research Site
Newmarket, Ontario, Canada, L3Y 5G8
Canada, Quebec
Research Site
Lachine, Quebec, Canada, H8S 2E4
Research Site
Pointe-Claire, Quebec, Canada, H9R 3J1
Denmark
Research Site
Aalborg, Denmark, 9000
Research Site
Ballerup, Denmark, 2750
Research Site
Vejle, Denmark, 7100
France
Research Site
Lille Cedex, France, 59037
Research Site
Paris Cedex 13, France, 75651
Research Site
Vénissieux, France, 69200
Germany
Research Site
Bad Krozingen, Germany, 79189
Research Site
Dresden, Germany, 01307
Research Site
Heppenheim, Germany, 64646
Hong Kong
Research Site
Hong Kong, Hong Kong
Research Site
New Territories, Hong Kong
Netherlands
Research Site
Alkmaar, Netherlands, 1815 JD
Research Site
Amsterdam, Netherlands, 1105 AZ
Research Site
Groningen, Netherlands, 9713 GZ
Poland
Research Site
Lodz, Poland, 90-368
Research Site
Warszawa, Poland, 04-730
South Africa
Research Site
Midrand, Gauteng, South Africa, 1685
Research Site
Observatory, Western Cape, South Africa, 7925
Research Site
Somerset West, Western Cape, South Africa, 7130
Spain
Research Site
Cordoba, Andalucía, Spain, 14004
Research Site
Zaragoza, Aragón, Spain, 50009
Research Site
Reus, Cataluña, Spain, 43204
Switzerland
Research Site
Lugano, Switzerland, 6900
Research Site
Reinach, Switzerland, 4153
United Kingdom
Research Site
Liverpool, United Kingdom, L22 0LG
Research Site
London, United Kingdom, NW3 2QG
Research Site
Telford, United Kingdom, TF1 6TF
Research Site
West Bromwich, United Kingdom, B71 4HJ
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01763905     History of Changes
Other Study ID Numbers: 20110116  2012-001364-30 
Study First Received: January 7, 2013
Results First Received: September 2, 2015
Last Updated: November 18, 2015
Health Authority: Hong Kong: Department of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Australia: Department of Health and Ageing Therapeutic Goods Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Spain: Agencia Española de Medicamentos y Productos Sanitarios
South Africa: Medicines Control Council
Switzerland: Swissmedic
Belgium: Federal Agency for Medicinal Products and Health Products
Denmark: Danish Health and Medicines Authority
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Canada: Health Canada
United States: Food and Drug Administration

Keywords provided by Amgen:
High Cholesterol, Treatment for high cholesterol, Lowering cholesterol, Lowering high cholesterol, Hypercholesterolemia

Additional relevant MeSH terms:
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Ezetimibe
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 27, 2016