Hypercholesterolemia Clinical Trial
Official title:
A Multicenter, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of Evolocumab
| Verified date | February 2019 |
| Source | Amgen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study was to characterize the safety and tolerability of long-term administration of evolocumab in adults with known coronary artery disease and hypercholesterolemia.
| Status | Completed |
| Enrollment | 770 |
| Est. completion date | March 9, 2018 |
| Est. primary completion date | March 9, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 99 Years |
| Eligibility |
Inclusion Criteria: - Completed week 80 of study 20120153 (NCT01813422). Exclusion Criteria: - Did not complete investigational product in the 20120153 parent study - Have an unstable medical condition, in the judgment of the investigator - Known sensitivity to any of the products to be administered during dosing - Currently enrolled in another investigational device or drug study (excluding evolocumab (AMG 145) parent study), or less than 30 days since ending another investigational device or drug study(s),or receiving other investigational agent(s) |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Research Site | Cordoba | Córdoba |
| Argentina | Research Site | Córdoba | |
| Argentina | Research Site | Córdoba | |
| Argentina | Research Site | La Plata | Buenos Aires |
| Australia | Research Site | Adelaide | South Australia |
| Australia | Research Site | Chermside | Queensland |
| Australia | Research Site | Epping | Victoria |
| Australia | Research Site | Footscray | Victoria |
| Australia | Research Site | Fullarton | South Australia |
| Australia | Research Site | Herston | Queensland |
| Australia | Research Site | Liverpool | New South Wales |
| Australia | Research Site | Nedlands | Western Australia |
| Australia | Research Site | New Lambton Heights | New South Wales |
| Belgium | Research Site | Antwerpen | |
| Belgium | Research Site | Edegem | |
| Belgium | Research Site | Genk | |
| Belgium | Research Site | Hasselt | |
| Belgium | Research Site | Lodelinsart | |
| Brazil | Research Site | Porto Alegre | Rio Grande Do Sul |
| Brazil | Research Site | São Paulo | |
| Canada | Research Site | Calgary | Alberta |
| Canada | Research Site | Halifax | Nova Scotia |
| Canada | Research Site | Laval | Quebec |
| Canada | Research Site | London | Ontario |
| Canada | Research Site | Montreal | Quebec |
| Canada | Research Site | Québec | Quebec |
| Canada | Research Site | St. Johns | Newfoundland and Labrador |
| Canada | Research Site | Toronto | Ontario |
| Canada | Research Site | Toronto | Ontario |
| Canada | Research Site | Victoria | British Columbia |
| Canada | Research Site | Winnipeg | Manitoba |
| Chile | Research Site | Temuco | Cautín |
| Czechia | Research Site | Brno | |
| Czechia | Research Site | Hradec Kralove | |
| Czechia | Research Site | Praha 2 | |
| Czechia | Research Site | Zlin | |
| France | Research Site | Besancon cedex | |
| France | Research Site | Chambray les Tours | |
| France | Research Site | Marseille cedex 5 | |
| France | Research Site | Paris | |
| France | Research Site | Pessac Cedex | |
| Germany | Research Site | Essen | |
| Greece | Research Site | Athens | |
| Greece | Research Site | Athens | |
| Greece | Research Site | Heraklion | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Debrecen | |
| Hungary | Research Site | Szeged | |
| Iceland | Research Site | Reykjavik | |
| Ireland | Research Site | Galway | |
| Israel | Research Site | Hadera | |
| Israel | Research Site | Jerusalem | |
| Italy | Research Site | Novara | |
| Italy | Research Site | Rozzano MI | |
| Italy | Research Site | Sesto San Giovanni (MI) | |
| Italy | Research Site | Torino | |
| Korea, Republic of | Research Site | Daejeon | |
| Korea, Republic of | Research Site | Seongnam-si, Gyeonggi-do | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Malaysia | Research Site | Kuantan | Pahang |
| Malaysia | Research Site | Penang | |
| Mexico | Research Site | Aguascalientes | |
| Mexico | Research Site | Culiacan | Sinaloa |
| Mexico | Research Site | Guadalajara | Jalisco |
| Mexico | Research Site | San Luis Potosi | San Luis Potosí |
| Netherlands | Research Site | Alkmaar | |
| Netherlands | Research Site | Amsterdam | |
| Netherlands | Research Site | Amsterdam | |
| Netherlands | Research Site | Leeuwarden | |
| Netherlands | Research Site | Nijmegen | |
| Netherlands | Research Site | Rotterdam | |
| Netherlands | Research Site | Tilburg | |
| Netherlands | Research Site | Utrecht | |
| Netherlands | Research Site | Zwolle | |
| Norway | Research Site | Oslo | |
| Poland | Research Site | Chrzanow | |
| Poland | Research Site | Kedzierzyn Kozle | |
| Poland | Research Site | Krakow | |
| Poland | Research Site | Krakow | |
| Poland | Research Site | Lodz | |
| Poland | Research Site | Warszawa | |
| Russian Federation | Research Site | Kemerovo | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Moscow | |
| South Africa | Research Site | Centurion | Gauteng |
| South Africa | Research Site | Kuils River | Western Cape |
| South Africa | Research Site | Sunninghill | Gauteng |
| Spain | Research Site | Barcelona | Cataluña |
| Spain | Research Site | Gijon | Asturias |
| Spain | Research Site | L Hospitalet De Llobregat | Cataluña |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Malaga | Andalucía |
| Sweden | Research Site | Göteborg | |
| Sweden | Research Site | Stockholm | |
| Switzerland | Research Site | Geneva 14 | |
| Taiwan | Research Site | New Taipei | |
| United Kingdom | Research Site | Newcastle Upon Tyne | |
| United States | Research Site | Amarillo | Texas |
| United States | Research Site | Bay City | Michigan |
| United States | Research Site | Bethesda | Maryland |
| United States | Research Site | Canton | Ohio |
| United States | Research Site | Columbia | Maryland |
| United States | Research Site | Columbia | Missouri |
| United States | Research Site | Covington | Louisiana |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Duluth | Minnesota |
| United States | Research Site | Fargo | North Dakota |
| United States | Research Site | Huntsville | Alabama |
| United States | Research Site | Jacksonville | Florida |
| United States | Research Site | Lexington | Kentucky |
| United States | Research Site | Long Beach | California |
| United States | Research Site | Midland | Michigan |
| United States | Research Site | Mobile | Alabama |
| United States | Research Site | Munster | Indiana |
| United States | Research Site | Oak Ridge | Tennessee |
| United States | Research Site | Ridgewood | New Jersey |
| United States | Research Site | Saint Cloud | Minnesota |
| United States | Research Site | San Diego | California |
| United States | Research Site | Toledo | Ohio |
| United States | Research Site | Torrance | California |
| United States | Research Site | Wichita Falls | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Amgen |
United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, Czechia, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Korea, Republic of, Malaysia, Mexico, Netherlands, Norway, Poland, Russian Federation, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events | The severity of each adverse event (AE) was graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 criteria, where Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe or medically significant AE, Grade 4 = Life-threatening consequences, and Grade 5 = death related to AE. An adverse device effect was defined as any adverse event related to the use of a medical device (autoinjector/pen or automated mini doser [AMD]), including but not limited to, AEs resulting from insufficient or inadequate Instructions for Use, AEs resulting from any malfunction of the device, or AEs resulting from use error or from intentional misuse of the device. |
From first dose of evolocumab up to 30 days after the last dose, or end of study, whichever was earlier, up to 108 weeks. | |
| Secondary | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Baseline (of study 20120153) and weeks 0, 4, 12, 24, 36, 48, 52, 76, and 104 of study 20140128 |
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