Getting to an Improved Understanding of Low-Density Lipoprotein Cholesterol and Dyslipidemia Management (GOULD) a Registry of High Cardiovascular Risk Subjects in the United States

NCT02993120 | Completed

• 1 other identifier: 20150230
• Study Type: observational
• Target: 5,006
• Locations: 1 country
• Sites: 118

Brief Summary

This is a multicenter observational cohort study with both retrospective and prospective data collection components in subjects with ASCVD. The purpose of this study is to better understand cholesterol treatment patterns in the context of a changing landscape in subjects with ASCVD.

Conditions

Medical Conditions to be Studied; Dyslipidemia; ASCVD Management

Outcome Measures

Primary Outcomes (1)

• Low-density lipoprotein (LDL) treatment patterns

  Describe low-density lipoprotein (LDL) treatment patterns over time in subjects with clinical ASCVD

  Through study completion, an average of 3 years

Secondary Outcomes (9)

• LDL-C levels and measurement patterns

  Through study completion, an average of 3 years

• Subject Characteristics

  Through study completion, an average of 3 years

• Subject understanding of CV risk

  Through study completion, an average of 3 years

• Goals of Lipid Management

  Through study completion, an average of 3 years

• Attitudes towards lipid lowering treatment (LLT)

  Through study completion, an average of 3 years

Study Arms (3)

Cohort 1

For the cohort of approximately 500 subjects taking a PCSK9i at baseline: proof consisting of a current prescription for an approved PCSK9i and subject confirmation that they have taken a PCSK9i within 30 days prior to enrollment is necessary.

Cohort 2

• For the cohort of approximately 2000 subjects with LDL-C ≥ 100 mg/dL: confirmation of LDL-C ≥100 mg/dL with no change in LLT for 4 weeks.

Cohort 3

For the cohort of approximately 2500 subjects with LDL-C 70-99 mg/dL: confirmation of LDL-C 70-99 mg/dL with no change in LLT for 4 weeks

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

* Adults (18-44 years) * Adults (45-64 years) * Adults (65-74 years) * Adults (75 years and older) * Sex: Male and Female

You may qualify if:

• Subject
• ≥ 18 years of age at signing of informed consent
• Undergoing treatment with a statin or other non-statin lipid lowering medication
• at least 1 planned visit in the next 12 months
• available for follow-up questionnaires
• established ASCVD defined as meeting at least 1 of the following criteria:
• coronary artery disease
• prior history of myocardial infarction
• coronary or other arterial revascularization
• ischemic stroke or transient ischemic attack
• documented peripheral arterial disease secondary to atherosclerosis (eg., aortic aneurysm, ankle brachial index \< 0.9, imaging evidence of \> 50% stenosis in any peripheral artery, or intermittent claudication)
• carotid artery stenosis
• LDL-C levels\>69 mg/dL except in subjects assigned to the PCSK9i cohort Cohorts
• Cohorts are assigned based upon most recent LDL-C level prior to enrollment
• For the cohort of approximately 500 subjects taking a PCSK9i at baseline: proof consisting of a current prescription for an approved PCSK9i and subject confirmation that they have taken a PCSK9i within 30 days prior to enrollment is necessary

You may not qualify if:

• Subject
• Unable or unwilling to provide informed consent including but not limited to cognitive or language barriers
• Current or planned participation in an interventional clinical study involving any investigational medical device or drug treatment at the time of enrollment or in the 6 months prior to enrollment. Subjects who chose to participate in an interventional clinical study of either device or drug treatment after enrollment will be removed from the GOULD study
• Life expectancy \< 12 months
• Currently pregnant, breast feeding, or planning to become pregnant

Sponsors & Collaborators

• Amgen: lead

Study Sites (118)

Research Site

Chandler, Arizona, 85224, United States

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Glendale, Arizona, 85306, United States

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Tucson, Arizona, 85712, United States

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Tucson, Arizona, 85741, United States

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Tucson, Arizona, 85745, United States

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Canoga Park, California, 91303, United States

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Cerritos, California, 90703, United States

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Los Angeles, California, 90048, United States

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Oxnard, California, 93030, United States

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Rancho Mirage, California, 92270, United States

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Sacramento, California, 95823, United States

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Wildomar, California, 92595, United States

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Colorado Springs, Colorado, 80906, United States

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Colorado Springs, Colorado, 80909, United States

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Lafayette, Colorado, 80026, United States

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Bloomfield, Connecticut, 06002, United States

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Bridgeport, Connecticut, 06610, United States

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Hartford, Connecticut, 06102, United States

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Stamford, Connecticut, 06905, United States

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Boca Raton, Florida, 33434, United States

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Brandon, Florida, 33511, United States

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Brooksville, Florida, 34601, United States

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Daytona Beach, Florida, 32114, United States

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Hollywood, Florida, 33021, United States

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Homestead, Florida, 33030, United States

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Jacksonville, Florida, 32256, United States

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Jacksonville, Florida, 32277, United States

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Jacksonville Beach, Florida, 32250, United States

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Miami, Florida, 33015, United States

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Miami, Florida, 33122, United States

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Miami, Florida, 33126, United States

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Miami, Florida, 33135, United States

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Miami, Florida, 33155, United States

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Miami, Florida, 33165, United States

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Miami Beach, Florida, 33140, United States

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Naples, Florida, 34102, United States

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Pembroke Pines, Florida, 33028, United States

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Pensacola, Florida, 32504, United States

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Rockledge, Florida, 32955, United States

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Winter Park, Florida, 32792, United States

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Cumming, Georgia, 30041, United States

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Smyrna, Georgia, 30082, United States

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Boise, Idaho, 83712, United States

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Coeur d'Alene, Idaho, 83814, United States

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Meridian, Idaho, 83642, United States

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Nampa, Idaho, 83686, United States

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Arlington Heights, Illinois, 60005, United States

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Chicago, Illinois, 60604, United States

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Chicago, Illinois, 60637, United States

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Evanston, Illinois, 60201, United States

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Morton, Illinois, 61550, United States

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Evansville, Indiana, 47713, United States

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Michigan City, Indiana, 46360, United States

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Davenport, Iowa, 52803, United States

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Des Moines, Iowa, 50309, United States

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Covington, Kentucky, 41011, United States

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Alexandria, Louisiana, 71301, United States

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Eunice, Louisiana, 70535, United States

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Monroe, Louisiana, 71201, United States

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Portland, Maine, 04101, United States

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Baltimore, Maryland, 21204, United States

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Elkridge, Maryland, 21075, United States

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Great Barrington, Massachusetts, 01230, United States

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Natick, Massachusetts, 01760, United States

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Worcester, Massachusetts, 01655, United States

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Alpena, Michigan, 49707, United States

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Detroit, Michigan, 48236, United States

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Flint, Michigan, 48504, United States

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Grand Rapids, Michigan, 49546, United States

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Lansing, Michigan, 48912, United States

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Coon Rapids, Minnesota, 55433, United States

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Minneapolis, Minnesota, 55407, United States

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Port Gibson, Mississippi, 39150, United States

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Columbia, Missouri, 65212, United States

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St Louis, Missouri, 63141, United States

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Lincoln, Nebraska, 68510, United States

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Lincoln, Nebraska, 68526, United States

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Omaha, Nebraska, 68144, United States

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Las Vegas, Nevada, 89117, United States

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Cedar Knolls, New Jersey, 07927, United States

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Albany, New York, 12206, United States

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Buffalo, New York, 14215, United States

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Kingston, New York, 12401, United States

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Rochester, New York, 14642, United States

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Greensboro, North Carolina, 27401, United States

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Wilmington, North Carolina, 28401, United States

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Winston-Salem, North Carolina, 27157, United States

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Fargo, North Dakota, 58103, United States

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Columbus, Ohio, 43205, United States

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Columbus, Ohio, 43214, United States

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Columbus, Ohio, 43231, United States

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Dayton, Ohio, 45406, United States

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Downingtown, Pennsylvania, 19335, United States

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Doylestown, Pennsylvania, 18901, United States

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Jersey Shore, Pennsylvania, 17740, United States

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Levittown, Pennsylvania, 19056, United States

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Wynnewood, Pennsylvania, 19096, United States

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Providence, Rhode Island, 02906, United States

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Providence, Rhode Island, 02908, United States

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Charleston, South Carolina, 29412, United States

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Greer, South Carolina, 29651, United States

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Murrells Inlet, South Carolina, 29576, United States

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Summerville, South Carolina, 29485, United States

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Oak Ridge, Tennessee, 37830, United States

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Dallas, Texas, 75235, United States

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Houston, Texas, 77061, United States

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Humble, Texas, 77338, United States

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Kingwood, Texas, 77339, United States

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Lufkin, Texas, 75904, United States

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McKinney, Texas, 75071, United States

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Mesquite, Texas, 75149, United States

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Missouri City, Texas, 77459, United States

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Sugar Land, Texas, 77478, United States

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Tomball, Texas, 77375, United States

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Hopewell, Virginia, 23860, United States

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Norfolk, Virginia, 23510, United States

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Winchester, Virginia, 22601, United States

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Bellevue, Washington, 98004, United States

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Related Publications (8)

• Arnold SV, de Lemos JA, Rosenson RS, Ballantyne CM, Liu Y, Mues KE, Alam S, Elliott-Davey M, Bhatt DL, Cannon CP, Kosiborod M; GOULD Investigators. Use of Guideline-Recommended Risk Reduction Strategies Among Patients With Diabetes and Atherosclerotic Cardiovascular Disease. Circulation. 2019 Aug 13;140(7):618-620. doi: 10.1161/CIRCULATIONAHA.119.041730. Epub 2019 Jun 7. No abstract available.

  PMID: 31174429 BACKGROUND

• Arnold SV, Cannon CP, de Lemos JA, Rosenson RS, Ballantyne CM, Liu Y, Alam S, Mues KE, Bhatt DL, Kosiborod M; GOULD Investigators. What Do US Physicians and Patients Think About Lipid-Lowering Therapy and Goals of Treatment? Results From the GOULD Registry. J Am Heart Assoc. 2021 Aug 17;10(16):e020893. doi: 10.1161/JAHA.120.020893. Epub 2021 Aug 7.

  PMID: 34369165 BACKGROUND

• Cannon CP, de Lemos JA, Rosenson RS, Ballantyne CM, Liu Y, Yazdi D, Elliott-Davey M, Mues KE, Bhatt DL, Kosiborod MN; GOULD Investigators. Getting to an ImprOved Understanding of Low-Density Lipoprotein-Cholesterol and Dyslipidemia Management (GOULD): Methods and baseline data of a registry of high cardiovascular risk patients in the United States. Am Heart J. 2020 Jan;219:70-77. doi: 10.1016/j.ahj.2019.10.014. Epub 2019 Oct 31.

  PMID: 31726422 BACKGROUND

• Arnold SV, de Lemos JA, Liu Y, Mues KE, Bhatt DL, Cannon CP, Kosiborod M. Adherence to Guideline Medication Recommendations to Prevent Atherosclerotic Cardiovascular Disease Progression Among Adults With Prior Myocardial Infarction. JAMA Netw Open. 2020 Apr 1;3(4):e203032. doi: 10.1001/jamanetworkopen.2020.3032.

  PMID: 32301989 BACKGROUND

• Shaik A, Kosiborod M, de Lemos JA, Gao Q, Mues KE, Alam S, Bhatt DL, Cannon CP, Ballantyne CM, Rosenson RS; GOULD Investigators. Use of lipid-lowering therapies in patients with chronic kidney disease and atherosclerotic cardiovascular disease: 2-year results from Getting to an imprOved Understanding of Low-Density lipoprotein cholesterol and dyslipidemia management (GOULD). Clin Cardiol. 2022 Dec;45(12):1303-1310. doi: 10.1002/clc.23923. Epub 2022 Sep 19.

  PMID: 36124341 BACKGROUND

• Arnold SV, de Lemos JA, Zheng L, Rosenson RS, Ballantyne CM, Alam S, Bhatt DL, Cannon CP, Kosiborod M; GOULD Investigators. Use of optimal medical therapy in patients with diabetes and atherosclerotic cardiovascular disease: Insights from a prospective longitudinal cohort study. Diabetes Obes Metab. 2023 Jun;25(6):1750-1757. doi: 10.1111/dom.15032. Epub 2023 Mar 7.

  PMID: 36843558 BACKGROUND

• Peterson BE, Bhatt DL, Ballantyne CM, de Lemos JA, Rosenson RS, Kosiborod MN, Cannon CP; GOULD Investigators. Intensity of Lipid-Lowering Therapy Among Patients With Polyvascular Disease. JAMA Netw Open. 2023 Mar 1;6(3):e234709. doi: 10.1001/jamanetworkopen.2023.4709.

  PMID: 36972054 BACKGROUND

• Cannon CP, Ballantyne CM, Bhatt DL, de Lemos JA, Gao Q, Kui N, Rosenson RS, Mues KE, Exter J, Alam S, Kosiborod MN; GOULD EDU Investigators. GOULD EDU: Cluster-Randomized Trial of an Educational Intervention to Improve Lipid-Lowering Guideline Adherence. JACC Adv. 2026 Jan;5(1):102403. doi: 10.1016/j.jacadv.2025.102403. Epub 2025 Dec 3.

  PMID: 41344145 DERIVED

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2016
• First Posted: December 15, 2016
• Study Start: December 6, 2016
• Primary Completion: August 6, 2021
• Study Completion: August 6, 2021
• Last Updated: May 3, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.

Locations

US (118)