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: July 8, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Hyperlipidemia
Biological: evolocumab (AMG 145)
Other: Ezetimibe
Other: Placebo
Phase 2

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 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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Percent change from baseline in low density lipoprotein cholesterol [ Time Frame: 12 week treatment duration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 160
Study Start Date: June 2011
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 4 with Ezetimibe
Dose 3 of subcutaneous evolocumab (AMG 145). Oral Ezetimibe once a day
Biological: evolocumab (AMG 145)
Patients will receive evolocumab (AMG 145) every 4 weeks
Other: Ezetimibe
Patients will take Ezetimibe once a day
Experimental: Group 1
Dose 1 of subcutaneous evolocumab (AMG 145)
Biological: evolocumab (AMG 145)
Patients will receive evolocumab (AMG 145) every 4 weeks
Experimental: Group 2
Dose 2 of subcutaneous evolocumab (AMG 145)
Biological: evolocumab (AMG 145)
Patients will receive evolocumab (AMG 145) every 4 weeks
Experimental: Group 3
Dose 3 of subcutaneous evolocumab (AMG 145)
Biological: evolocumab (AMG 145)
Patients will receive evolocumab (AMG 145) every 4 weeks
Experimental: Group 5
Oral Ezetimibe & subcutaneous Placebo
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  • 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
  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: NCT01375764

  Show 42 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided by Amgen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01375764     History of Changes
Other Study ID Numbers: 20090159
Study First Received: June 16, 2011
Last Updated: July 8, 2014
Health Authority: Australia: Therapeutic Goods Administration
Belgium: Directorate-General for Medicinal Products
Canada: Health Canada
Denmark: Laegemiddelstyrelsen
Finland: Lääkelaitos
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
United States: Food and Drug Administration

Keywords provided by Amgen:
Cholesterol
High Cholesterol
Raised Cholesterol
Elevated Cholesterol
Statin intolerant
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
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 16, 2014