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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: April 2, 2013
Last verified: April 2013
History of Changes
  Purpose

The primary hypothesis is that a dose of 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: 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:

MedlinePlus related topics: Cholesterol Statins
Drug Information available for: Ezetimibe
U.S. FDA Resources

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 AMG 145. Oral Ezetimibe once a day
 Biological: AMG 145
Patients will receive AMG 145 every 4 weeks
Other: Ezetimibe
Patients will take Ezetimibe once a day
Experimental: Group 1
Dose 1 of subcutaneous AMG 145
 Biological: AMG 145
Patients will receive AMG 145 every 4 weeks
Experimental: Group 2
Dose 2 of subcutaneous AMG 145
 Biological: AMG 145
Patients will receive AMG 145 every 4 weeks
Experimental: Group 3
Dose 3 of subcutaneous AMG 145
 Biological: AMG 145
Patients will receive 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
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:
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site

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: April 2, 2013
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
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Ezetimibe
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013