Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects -2 (GAUSS-2)
This study is currently recruiting participants.
Verified June 2013 by Amgen
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01763905
First received: January 7, 2013
Last updated: June 10, 2013
Last verified: June 2013
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Purpose
The primary hypothesis is that both dosing regimens of AMG 145 will be well tolerated and will result in greater reduction of Low Density Lipoprotein (LDL-C), than ezetimibe in hypercholesterolemic subjects unable to tolerate an effective dose of a statin.
| Condition | Intervention | Phase |
|---|---|---|
|
Hyperlipidemia |
Drug: AMG 145 Other: Placebo (administered subcutaneously) Drug: Ezetimibe Other: Placebo (administered orally) |
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:
- Mean percent change from baseline in low density lipoprotein-cholesterol [ Time Frame: 10 and 12 Weeks ] [ Designated as safety issue: No ]Mean percent change from baseline in low density lipoprotein-cholesterol
- Percent change from baseline in low density lipoprotein-cholesterol [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]Percent change from baseline in low density lipoprotein-cholesterol
Secondary Outcome Measures:
- Mean change from baseline in low density lipoprotein-cholesterol [ Time Frame: 10 and 12 Weeks ] [ Designated as safety issue: No ]Mean change from baseline in low density lipoprotein-cholesterol
- Change from baseline in low density lipoprotein-cholesterol [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]Change from baseline in low density lipoprotein-cholesterol
- Mean low density lipoprotein-cholesterol response (low density lipoprotein-cholesterol < 70 mg/dL [1.8 mmol/L]) [ Time Frame: 10 and 12 Weeks ] [ Designated as safety issue: No ]Mean low density lipoprotein-cholesterol response (low density lipoprotein-cholesterol < 70 mg/dL [1.8 mmol/L])
- Low density lipoprotein-cholesterol response (low density lipoprotein-cholesterol < 70 mg/dL [1.8 mmol/L]) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]Low density lipoprotein-cholesterol response (low density lipoprotein-cholesterol < 70 mg/dL [1.8 mmol/L])
- Mean percent change from baseline in non-high density lipoprotein-cholesterol [ Time Frame: 10 and 12 Weeks ] [ Designated as safety issue: No ]Mean percent change from baseline in non-high density lipoprotein-cholesterol
- Percent change from baseline in non-high density lipoprotein-cholesterol [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]Percent change from baseline in non-high density lipoprotein-cholesterol
- Mean percent change from baseline in apolipoprotein B [ Time Frame: 10 and 12 Weeks ] [ Designated as safety issue: No ]Mean percent change from baseline in apolipoprotein B
- Percent change from baseline in apolipoprotein B [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]Percent change from baseline in apolipoprotein B
- Mean percent change from baseline in the total cholesterol/high density lipoprotein-cholesterol ratio [ Time Frame: 10 and 12 Weeks ] [ Designated as safety issue: No ]Mean percent change from baseline in the total cholesterol/high density lipoprotein-cholesterol ratio
- Percent change from baseline in the total cholesterol/high density lipoprotein-cholesterol ratio [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]Percent change from baseline in the total cholesterol/high density lipoprotein-cholesterol ratio
- Mean percent change from baseline in apolipoprotein B/apolipoprotein A1 ratio [ Time Frame: 10 and 12 Weeks ] [ Designated as safety issue: No ]Mean percent change from baseline in apolipoprotein B/apolipoprotein A1 ratio
- Percent change from baseline in apolipoprotein B/apolipoprotein A1 ratio [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]Percent change from baseline in apolipoprotein B/apolipoprotein A1 ratio
- Mean percent change from baseline in lipoprotein (a) [ Time Frame: 10 and 12 Weeks ] [ Designated as safety issue: No ]Mean percent change from baseline in lipoprotein (a)
- Percent change from baseline in lipoprotein (a) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]Percent change from baseline in lipoprotein (a)
- Mean percent change from baseline in triglycerides [ Time Frame: 10 and 12 Weeks ] [ Designated as safety issue: No ]Mean percent change from baseline in triglycerides
- Percent change from baseline in triglycerides [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]Percent change from baseline in triglycerides
- Mean percent change from baseline in high density lipoprotein-cholesterol [ Time Frame: 10 and 12 Weeks ] [ Designated as safety issue: No ]Mean percent change from baseline in high density lipoprotein-cholesterol
- Percent change from baseline in high density lipoprotein-cholesterol [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]Percent change from baseline in high density lipoprotein-cholesterol
- Mean percent change from baseline in very low density lipoprotein-cholesterol [ Time Frame: 10 and 12 Weeks ] [ Designated as safety issue: No ]Mean percent change from baseline in very low density lipoprotein-cholesterol
- Percent change from baseline in very low density lipoprotein-cholesterol [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]Percent change from baseline in very low density lipoprotein-cholesterol
| Estimated Enrollment: | 300 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
Dose 1 of subcutaneous AMG 145 every 2 weeks and placebo orally/dailly
|
Drug: AMG 145
Subjects will receive AMG 145 every 2 weeks or monthly
Other: Placebo (administered orally)
Subject will receive Placebo daily
|
|
Experimental: Arm 2
Dose 2 of subcutaneous AMG 145 monthly and placebo orally/daily
|
Drug: AMG 145
Subjects will receive AMG 145 every 2 weeks or monthly
Other: Placebo (administered orally)
Subject will receive Placebo daily
|
|
Active Comparator: Arm 3
Dose 3 of subcutaneous placebo every 2 weeks and Ezetimibe orally/daily
|
Other: Placebo (administered subcutaneously)
Subjects will receive Placebo every 2 weeks or monthly. All patients at screening will participate in the placebo run-in.
Drug: Ezetimibe
Subjects will receive Ezetimibe daily
|
|
Active Comparator: Arm 4
Dose 4 of subcutaneous placebo monthly and Ezetimibe orally/daily
|
Other: Placebo (administered subcutaneously)
Subjects will receive Placebo every 2 weeks or monthly. All patients at screening will participate in the placebo run-in.
Drug: Ezetimibe
Subjects will receive Ezetimibe daily
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| 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:
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01763905
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Contacts
| Contact: Amgen Call Center | 866-572-6436 |
Hide Study LocationsLocations
| United States, California | |
| Research Site | Recruiting |
| Carmichael, California, United States, 95608 | |
| Research Site | Recruiting |
| Los Angeles, California, United States, 90048 | |
| Research Site | Recruiting |
| Mission Viejo, California, United States, 92691 | |
| Research Site | Recruiting |
| Thousand Oaks, California, United States, 91360 | |
| Research Site | Recruiting |
| Westlake Village, California, United States, 91361 | |
| United States, Georgia | |
| Research Site | Recruiting |
| Atlanta, Georgia, United States, 30338 | |
| Research Site | Recruiting |
| Atlanta, Georgia, United States, 30342 | |
| Research Site | Recruiting |
| Savannah, Georgia, United States, 31406 | |
| United States, Maine | |
| Research Site | Recruiting |
| Auburn, Maine, United States, 04210 | |
| United States, Michigan | |
| Research Site | Recruiting |
| Traverse City, Michigan, United States, 49684 | |
| United States, Missouri | |
| Research Site | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| United States, Nevada | |
| Research Site | Recruiting |
| Henderson, Nevada, United States, 89052 | |
| Research Site | Recruiting |
| Las Vegas, Nevada, United States, 89117 | |
| Research Site | Recruiting |
| Las Vegas, Nevada, United States, 89148 | |
| United States, New York | |
| Research Site | Recruiting |
| New York, New York, United States, 10029 | |
| United States, North Carolina | |
| Research Site | Recruiting |
| Raleigh, North Carolina, United States, 27609 | |
| United States, Ohio | |
| Research Site | Recruiting |
| Akron, Ohio, United States, 44311 | |
| Research Site | Recruiting |
| Cincinnati, Ohio, United States, 45212 | |
| Research Site | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| United States, Oklahoma | |
| Research Site | Recruiting |
| Norman, Oklahoma, United States, 73069 | |
| United States, Texas | |
| Research Site | Recruiting |
| Houston, Texas, United States, 77030 | |
| Australia, New South Wales | |
| Research Site | Recruiting |
| Camperdown, New South Wales, Australia, 2015 | |
| Australia, Queensland | |
| Research Site | Recruiting |
| Milton, Queensland, Australia, 4064 | |
| Australia, Victoria | |
| Research Site | Recruiting |
| Melbourne, Victoria, Australia, 3004 | |
| Australia, Western Australia | |
| Research Site | Recruiting |
| Perth, Western Australia, Australia, 6000 | |
| Belgium | |
| Research Site | Recruiting |
| Brussels, Belgium, 1200 | |
| Research Site | Recruiting |
| Gent, Belgium, 9000 | |
| Research Site | Recruiting |
| La Louvière, Belgium, 7100 | |
| Canada, Ontario | |
| Research Site | Recruiting |
| Newmarket, Ontario, Canada, L3Y 5G8 | |
| Canada, Quebec | |
| Research Site | Recruiting |
| Lachine, Quebec, Canada, H8S 2E4 | |
| Research Site | Recruiting |
| Pointe-Claire, Quebec, Canada, H9R 3J1 | |
| Denmark | |
| Research Site | Recruiting |
| Aalborg, Denmark, 9000 | |
| Research Site | Recruiting |
| Ballerup, Denmark, 2750 | |
| Research Site | Recruiting |
| Vejle, Denmark, 7100 | |
| France | |
| Research Site | Recruiting |
| Lille Cedex, France, 59037 | |
| Research Site | Recruiting |
| Paris Cedex 13, France, 75651 | |
| Research Site | Recruiting |
| Vénissieux, France, 69200 | |
| Germany | |
| Research Site | Recruiting |
| Bad Krozingen, Germany, 79189 | |
| Research Site | Recruiting |
| Dresden, Germany, 01307 | |
| Research Site | Recruiting |
| Heppenheim, Germany, 64646 | |
| Hong Kong | |
| Research Site | Recruiting |
| Hong Kong, Hong Kong | |
| Research Site | Recruiting |
| New Territories, Hong Kong | |
| Netherlands | |
| Research Site | Recruiting |
| Alkmaar, Netherlands, 1815 JD | |
| Research Site | Recruiting |
| Amsterdam, Netherlands, 1105 AZ | |
| Research Site | Recruiting |
| Groningen, Netherlands, 9713 GZ | |
| Poland | |
| Research Site | Recruiting |
| Lodz, Poland, 90-368 | |
| Research Site | Recruiting |
| Warszawa, Poland, 04-730 | |
| South Africa | |
| Research Site | Recruiting |
| Midrand, Gauteng, South Africa, 1685 | |
| Research Site | Recruiting |
| Observatory, Western Cape, South Africa, 7925 | |
| Research Site | Recruiting |
| Somerset West, Western Cape, South Africa, 7130 | |
| Spain | |
| Research Site | Recruiting |
| Córdoba, AndalucÃ-a, Spain, 14004 | |
| Research Site | Recruiting |
| Zaragoza, Aragón, Spain, 50009 | |
| Research Site | Recruiting |
| Reus, Cataluña, Spain, 43204 | |
| Switzerland | |
| Research Site | Recruiting |
| Lugano, Switzerland, 6900 | |
| Research Site | Recruiting |
| Reinach, Switzerland, 4153 | |
| Research Site | Recruiting |
| Zurich, Switzerland, 8091 | |
| United Kingdom | |
| Research Site | Recruiting |
| Liverpool, United Kingdom, L22 0LG | |
| Research Site | Recruiting |
| London, United Kingdom, NW3 2QG | |
| Research Site | Recruiting |
| Telford, United Kingdom, TF1 6TF | |
| Research Site | Recruiting |
| West Bromwich, United Kingdom, B71 4HJ | |
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
No publications provided
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT01763905 History of Changes |
| Other Study ID Numbers: | 20110116 |
| Study First Received: | January 7, 2013 |
| Last Updated: | June 10, 2013 |
| 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 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 June 17, 2013