Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects (GAUSS)
This study has been completed.
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01375764
First received: June 16, 2011
Last updated: April 2, 2013
Last verified: April 2013
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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:
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
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| United States, California | |
| Research Site | |
| Anaheim, California, United States, 92801 | |
| Research Site | |
| Mission Viejo, California, United States, 92691 | |
| Research Site | |
| Westlake Village, California, United States, 91361 | |
| United States, Georgia | |
| Research Site | |
| Atlanta, Georgia, United States, 30342 | |
| Research Site | |
| Atlanta, Georgia, United States, 30338 | |
| Research Site | |
| Savannah, Georgia, United States, 31406 | |
| United States, Maine | |
| Research Site | |
| Auburn, Maine, United States, 04210 | |
| United States, Maryland | |
| Research Site | |
| Chevy Chase, Maryland, United States, 20815 | |
| United States, Montana | |
| Research Site | |
| Butte, Montana, United States, 59701 | |
| United States, Nevada | |
| Research Site | |
| Henderson, Nevada, United States, 89052 | |
| Research Site | |
| Las Vegas, Nevada, United States, 89117 | |
| 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 | |
| United States, Tennessee | |
| Research Site | |
| Bristol, Tennessee, United States, 37620 | |
| Australia, New South Wales | |
| Research Site | |
| Camperdown, New South Wales, Australia, 2015 | |
| Research Site | |
| Sydney, New South Wales, Australia, 2022 | |
| Australia, Victoria | |
| Research Site | |
| Melbourne, Victoria, Australia, 3004 | |
| Australia, Western Australia | |
| Research Site | |
| Perth, Western Australia, Australia, 6000 | |
| Belgium | |
| Research Site | |
| Bruxelles, Belgium, 1200 | |
| Research Site | |
| Uccle, Belgium, 1180 | |
| Canada, Newfoundland and Labrador | |
| Research Site | |
| St. John's, Newfoundland and Labrador, Canada, A1A 3R5 | |
| Research Site | |
| St. John’s, Newfoundland and Labrador, Canada, A1A 3R5 | |
| Canada, Quebec | |
| Research Site | |
| Lachine, Quebec, Canada, H8S 2E4 | |
| Denmark | |
| Research Site | |
| Ballerup, Denmark, 2750 | |
| Research Site | |
| Vejle, Denmark, 7100 | |
| Finland | |
| Research Site | |
| Helsinki, Finland, 00029 | |
| Research Site | |
| OYS, Finland, 90029 | |
| Spain | |
| Research Site | |
| Zaragoza, Aragón, Spain, 50009 | |
| Research Site | |
| Zaragoza, Aragón, Spain, 50009 | |
| Research Site | |
| Barcelona, Cataluña, Spain, 08036 | |
| Research Site | |
| L'Hospitalet de Llobregat, Cataluña, Spain, 08907 | |
| Research Site | |
| Reus, Cataluña, Spain, 43204 | |
| Research Site | |
| Barcelona, Cataluña, Spain, 08036 | |
| Research Site | |
| L'Hospitalet de Llobregat, Cataluña, Spain, 08907 | |
| Research Site | |
| Reus, Cataluña, Spain, 43204 | |
| Sweden | |
| Research Site | |
| Göteborg, Sweden, 411 36 | |
| Research Site | |
| Göteborg, Sweden, 411 36 | |
| Research Site | |
| Lund, Sweden, 222 21 | |
| Research Site | |
| Stockholm, Sweden, 141 86 | |
| Research Site | |
| Stockholm, Sweden, 111 35 | |
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: | 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 22, 2013