Hyperlipidemia and Mixed Dyslipidemia Clinical Trial
— OSLER-2Official title:
A Multicenter, Controlled, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 145
| Verified date | May 2019 |
| Source | Amgen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study will contribute to the evaluation of long-term safety, tolerability and efficacy of evolocumab (AMG 145) in adults with hyperlipidemia and adults with mixed dyslipidemia.
| Status | Completed |
| Enrollment | 3681 |
| Est. completion date | May 31, 2018 |
| Est. primary completion date | May 31, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 85 Years |
| Eligibility |
Inclusion Criteria: - Complete a qualifying evolocumab (AMG 145) parent study (ie, Study 20110114 [NCT01763827], 20110115 [NCT01763866], 20110116 [NCT01763905], 20110117 [NCT01763918], 20110109 [NCT01516879], 20120122 [NCT01953328], 20120332 [NCT01984424], 20120348 [NCT01849497], or 20120356 [NCT01879319]). Exclusion Criteria: - Experienced a treatment-related serious adverse event that led to study drug discontinuation in the 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 |
|---|---|---|---|
| Australia | Research Site | Ashford | South Australia |
| Australia | Research Site | Auchenflower | Queensland |
| Australia | Research Site | Camperdown | New South Wales |
| Australia | Research Site | Carina Heights | Queensland |
| Australia | Research Site | Fullarton | South Australia |
| Australia | Research Site | Heidelberg Heights | Victoria |
| Australia | Research Site | Maroubra | New South Wales |
| Australia | Research Site | Melbourne | Victoria |
| Australia | Research Site | Perth | Western Australia |
| Australia | Research Site | Sherwood | Queensland |
| Australia | Research Site | Sydney | New South Wales |
| Australia | Research Site | Sydney | New South Wales |
| Australia | Research Site | Woolloongabba | Queensland |
| Austria | Research Site | Salzburg | |
| Belgium | Research Site | Anthée | |
| Belgium | Research Site | Blankenberge | |
| Belgium | Research Site | Bruxelles | |
| Belgium | Research Site | Bruxelles | |
| Belgium | Research Site | Chênée | |
| Belgium | Research Site | Gent | |
| Belgium | Research Site | Gozee | |
| Belgium | Research Site | Gribomont | |
| Belgium | Research Site | Halen | |
| Belgium | Research Site | Ham | |
| Belgium | Research Site | Hasselt | |
| Belgium | Research Site | La Louvière | |
| Belgium | Research Site | Linkebeek | |
| Belgium | Research Site | Oostende | |
| Belgium | Research Site | Tessenderlo | |
| Belgium | Research Site | Tremelo | |
| Belgium | Research Site | Vilvoorde | |
| Canada | Research Site | Bay Roberts | Newfoundland and Labrador |
| Canada | Research Site | Burnaby | British Columbia |
| Canada | Research Site | Cambridge | Ontario |
| Canada | Research Site | Chicoutimi | Quebec |
| Canada | Research Site | Granby | Quebec |
| Canada | Research Site | Greenfield Park | Quebec |
| Canada | Research Site | Hamilton | Ontario |
| Canada | Research Site | Kelowna | British Columbia |
| Canada | Research Site | Lachine | Quebec |
| Canada | Research Site | London | Ontario |
| Canada | Research Site | London | Ontario |
| Canada | Research Site | Montreal | Quebec |
| Canada | Research Site | Montreal | Quebec |
| Canada | Research Site | Montreal | Quebec |
| Canada | Research Site | Mount Pearl | Newfoundland and Labrador |
| Canada | Research Site | Newmarket | Ontario |
| Canada | Research Site | Oshawa | Ontario |
| Canada | Research Site | Peterborough | Ontario |
| Canada | Research Site | Pointe-Claire | Quebec |
| Canada | Research Site | Quebec | |
| Canada | Research Site | Sarnia | Ontario |
| Canada | Research Site | St. John's | Newfoundland and Labrador |
| Canada | Research Site | Surrey | British Columbia |
| Canada | Research Site | Toronto | Ontario |
| Canada | Research Site | Toronto | Ontario |
| Canada | Research Site | Toronto | Ontario |
| Canada | Research Site | Vancouver | British Columbia |
| Canada | Research Site | Woodstock | Ontario |
| Czechia | Research Site | Brno | |
| Czechia | Research Site | Brno | |
| Czechia | Research Site | Chomutov | |
| Czechia | Research Site | Hradec Kralove | |
| Czechia | Research Site | Kladno | |
| Czechia | Research Site | Litomerice | |
| Czechia | Research Site | Moravske Budejovice | |
| Czechia | Research Site | Olomouc | |
| Czechia | Research Site | Pardubice | |
| Czechia | Research Site | Plzen | |
| Czechia | Research Site | Praha 2 | |
| Czechia | Research Site | Praha 3 | |
| Czechia | Research Site | Praha 4 | |
| Czechia | Research Site | Praha 5 | |
| Czechia | Research Site | Slany | |
| Czechia | Research Site | Svitavy | |
| Denmark | Research Site | Aalborg | |
| Denmark | Research Site | Aarhus N | |
| Denmark | Research Site | Ballerup | |
| Denmark | Research Site | Glostrup | |
| Denmark | Research Site | Vejle | |
| France | Research Site | Brest Cedex 2 | |
| France | Research Site | Bron | |
| France | Research Site | Caen Cedex 9 | |
| France | Research Site | Dijon | |
| France | Research Site | Montpellier cedex 05 | |
| France | Research Site | Nantes Cedex 1 | |
| France | Research Site | Paris Cedex 12 | |
| France | Research Site | Paris Cedex 13 | |
| France | Research Site | Vénissieux | |
| Germany | Research Site | Bad Krozingen | |
| Germany | Research Site | Berlin | |
| Germany | Research Site | Berlin | |
| Germany | Research Site | Berlin (Hellersdorf) | |
| Germany | Research Site | Dresden | |
| Germany | Research Site | Heppenheim | |
| Germany | Research Site | Homburg | |
| Germany | Research Site | Köln | |
| Germany | Research Site | Leipzig | |
| Germany | Research Site | Magdeburg | |
| Germany | Research Site | Messkirch | |
| Germany | Research Site | München | |
| Germany | Research Site | Witten | |
| Hong Kong | Research Site | Hong Kong | |
| Hong Kong | Research Site | New Territories | |
| Hungary | Research Site | Baja | |
| Hungary | Research Site | Berettyoujfalu | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Eger | |
| Hungary | Research Site | Gyongyos | |
| Hungary | Research Site | Hodmezovasarhely | |
| Hungary | Research Site | Jaszbereny | |
| Hungary | Research Site | Komarom | |
| Hungary | Research Site | Mosonmagyarovar | |
| Hungary | Research Site | Pecs | |
| Hungary | Research Site | Szeged | |
| Italy | Research Site | Bologna | |
| Italy | Research Site | Cagliari | |
| Italy | Research Site | Chieti | |
| Italy | Research Site | Cinisello Balsamo (MI) | |
| Italy | Research Site | Ferrara | |
| Italy | Research Site | Milano | |
| Italy | Research Site | Napoli | |
| Italy | Research Site | Padova | |
| Italy | Research Site | Perugia | |
| Italy | Research Site | Pisa | |
| Italy | Research Site | Pisa | |
| Italy | Research Site | Trieste | |
| Japan | Research Site | Arakawa-ku | Tokyo |
| Japan | Research Site | Chiyoda-ku | Tokyo |
| Japan | Research Site | Chofu-shi | Tokyo |
| Japan | Research Site | Edogawa-ku | Tokyo |
| Japan | Research Site | Fukuoka-shi | Fukuoka |
| Japan | Research Site | Fukuoka-shi | Fukuoka |
| Japan | Research Site | Fukuoka-shi | Fukuoka |
| Japan | Research Site | Hachioji-shi | Tokyo |
| Japan | Research Site | Ibaraki-shi | Osaka |
| Japan | Research Site | Katsushika-ku | Tokyo |
| Japan | Research Site | Kitakyusyu-shi | Fukuoka |
| Japan | Research Site | Koriyama-shi | Fukushima |
| Japan | Research Site | Koriyama-shi | Fukushima |
| Japan | Research Site | Koriyama-shi | Fukushima |
| Japan | Research Site | Koriyama-shi | Fukushima |
| Japan | Research Site | Koriyama-shi | Fukushima |
| Japan | Research Site | Koshigaya-shi | Saitama |
| Japan | Research Site | Koto-ku | Tokyo |
| Japan | Research Site | Kyoto-shi | Kyoto |
| Japan | Research Site | Maebashi-shi | Gunma |
| Japan | Research Site | Minato-ku | Tokyo |
| Japan | Research Site | Minato-ku | Tokyo |
| Japan | Research Site | Morioka-shi | Iwate |
| Japan | Research Site | Niiza-shi | Saitama |
| Japan | Research Site | Noda-shi | Chiba |
| Japan | Research Site | Ota-ku | Tokyo |
| Japan | Research Site | Sapporo-shi | Hokkaido |
| Japan | Research Site | Sapporo-shi | Hokkaido |
| Japan | Research Site | Sapporo-shi | Hokkaido |
| Japan | Research Site | Sendai-shi | Miyagi |
| Japan | Research Site | Sendai-shi | Miyagi |
| Japan | Research Site | Sendai-shi | Miyagi |
| Japan | Research Site | Setagaya-ku | Tokyo |
| Japan | Research Site | Shibuya-ku | Tokyo |
| Japan | Research Site | Shinagawa-ku | Tokyo |
| Japan | Research Site | Shinagawa-ku | Tokyo |
| Japan | Research Site | Shinagawa-ku | Tokyo |
| Japan | Research Site | Shinagawa-ku | Tokyo |
| Japan | Research Site | Takamatsu-shi | Kagawa |
| Japan | Research Site | Takamatsu-shi | Kagawa |
| Japan | Research Site | Takasaki-shi | Gunma |
| Japan | Research Site | Tomigusuku-shi | Okinawa |
| Japan | Research Site | Toshima-ku | Tokyo |
| Japan | Research Site | Toyonaka-shi | Osaka |
| Japan | Research Site | Tsuchiura-shi | Ibaraki |
| Japan | Research Site | Yokohama-shi | Kanagawa |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Netherlands | Research Site | Amsterdam | |
| Netherlands | Research Site | Den Helder | |
| Netherlands | Research Site | Groningen | |
| Netherlands | Research Site | Groningen | |
| Netherlands | Research Site | Hoogeveen | |
| Netherlands | Research Site | Hoorn | |
| Netherlands | Research Site | Nijmegen | |
| Netherlands | Research Site | Rotterdam | |
| Netherlands | Research Site | Tilburg | |
| Netherlands | Research Site | Utrecht | |
| Netherlands | Research Site | Waalwijk | |
| Netherlands | Research Site | Zwijndrecht | |
| New Zealand | Research Site | Christchurch | |
| Norway | Research Site | Ålesund | |
| Norway | Research Site | Oslo | |
| Poland | Research Site | Lodz | |
| Russian Federation | Research Site | Barnaul | |
| Russian Federation | Research Site | Kemerovo | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Novosibirsk | |
| Russian Federation | Research Site | Saint Petersburg | |
| Russian Federation | Research Site | Saratov | |
| South Africa | Research Site | Amanzimtoti | KwaZulu-Natal |
| South Africa | Research Site | Bloemfontein | |
| South Africa | Research Site | Centurion | Gauteng |
| South Africa | Research Site | Johannesburg | Gauteng |
| South Africa | Research Site | Midrand | Gauteng |
| South Africa | Research Site | Observatory | Western Cape |
| South Africa | Research Site | Paarl | Western Cape |
| South Africa | Research Site | Parow | Western Cape |
| South Africa | Research Site | Somerset West | Western Cape |
| South Africa | Research Site | Sunninghill | Gauteng |
| Spain | Research Site | Cordoba | Andalucía |
| Spain | Research Site | L'Hospitalet de Llobregat | Cataluña |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Reus | Cataluña |
| Spain | Research Site | Zaragoza | Aragón |
| Sweden | Research Site | Göteborg | |
| Sweden | Research Site | Lund | |
| Sweden | Research Site | Örebro | |
| Sweden | Research Site | Stockholm | |
| Sweden | Research Site | Stockholm | |
| Sweden | Research Site | Stockholm | |
| Sweden | Research Site | Uddevalla | |
| Switzerland | Research Site | Bellinzona | |
| Switzerland | Research Site | Geneva 14 | |
| Switzerland | Research Site | Lausanne | |
| Switzerland | Research Site | Lugano | |
| Switzerland | Research Site | Muensterlingen | |
| Switzerland | Research Site | Reinach | |
| Switzerland | Research Site | St. Gallen | |
| Switzerland | Research Site | Zurich | |
| Switzerland | Research Site | Zurich | |
| Taiwan | Research Site | Kaohsiung | |
| Taiwan | Research Site | Taipei | |
| United Kingdom | Research Site | Birmingham | |
| United Kingdom | Research Site | Birmingham | |
| United Kingdom | Research Site | Blackpool | |
| United Kingdom | Research Site | Cardiff | |
| United Kingdom | Research Site | Chesterfield | |
| United Kingdom | Research Site | Chorley | |
| United Kingdom | Research Site | Coventry | |
| United Kingdom | Research Site | Doncaster | |
| United Kingdom | Research Site | Glasgow | |
| United Kingdom | Research Site | Glasgow | |
| United Kingdom | Research Site | Glasgow | |
| United Kingdom | Research Site | Liverpool | |
| United Kingdom | Research Site | Liverpool | |
| United Kingdom | Research Site | London | |
| United Kingdom | Research Site | London | |
| United Kingdom | Research Site | London | |
| United Kingdom | Research Site | Manchester | |
| United Kingdom | Research Site | Manchester | |
| United Kingdom | Research Site | Newcastle upon Tyne | |
| United Kingdom | Research Site | Reading | |
| United Kingdom | Research Site | Telford | |
| United Kingdom | Research Site | Wakefield | |
| United Kingdom | Research Site | West Bromwich | |
| United Kingdom | Research Site | Whitby | |
| United States | Research Site | Akron | Ohio |
| United States | Research Site | Anderson | South Carolina |
| United States | Research Site | Atlanta | Georgia |
| United States | Research Site | Atlanta | Georgia |
| United States | Research Site | Atlanta | Georgia |
| United States | Research Site | Auburn | Maine |
| United States | Research Site | Austin | Texas |
| United States | Research Site | Ayer | Massachusetts |
| United States | Research Site | Bangor | Maine |
| United States | Research Site | Bethesda | Maryland |
| United States | Research Site | Beverly Hills | California |
| United States | Research Site | Birmingham | Alabama |
| United States | Research Site | Birmingham | Alabama |
| United States | Research Site | Cadiz | Ohio |
| United States | Research Site | Canton | Ohio |
| United States | Research Site | Carmichael | California |
| United States | Research Site | Chandler | Arizona |
| United States | Research Site | Charleston | South Carolina |
| United States | Research Site | Chicago | Illinois |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Cleveland | Ohio |
| United States | Research Site | Columbia | Maryland |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Dayton | Ohio |
| United States | Research Site | Daytona Beach | Florida |
| United States | Research Site | DeLand | Florida |
| United States | Research Site | Duncansville | Pennsylvania |
| United States | Research Site | Edina | Minnesota |
| United States | Research Site | Encinitas | California |
| United States | Research Site | Endwell | New York |
| United States | Research Site | Fargo | North Dakota |
| United States | Research Site | Gainesville | Georgia |
| United States | Research Site | Henderson | Nevada |
| United States | Research Site | Hillsboro | Oregon |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Huntington Beach | California |
| United States | Research Site | Indianapolis | Indiana |
| United States | Research Site | Iowa City | Iowa |
| United States | Research Site | Jackson | Tennessee |
| United States | Research Site | Jacksonville | Florida |
| United States | Research Site | Kansas City | Kansas |
| United States | Research Site | Lansdale | Pennsylvania |
| United States | Research Site | Las Vegas | Nevada |
| United States | Research Site | Lexington | Kentucky |
| United States | Research Site | Little Rock | Arkansas |
| United States | Research Site | Littleton | Colorado |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | Louisville | Kentucky |
| United States | Research Site | Manlius | New York |
| United States | Research Site | Mansfield | Ohio |
| United States | Research Site | Marion | Ohio |
| United States | Research Site | Melbourne | Florida |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Mission Viejo | California |
| United States | Research Site | Monroe | Louisiana |
| United States | Research Site | Mount Pleasant | South Carolina |
| United States | Research Site | Munster | Indiana |
| United States | Research Site | Nashville | Tennessee |
| United States | Research Site | New Windsor | New York |
| United States | Research Site | New York | New York |
| United States | Research Site | Newport Beach | California |
| United States | Research Site | Norfolk | Virginia |
| United States | Research Site | Norman | Oklahoma |
| United States | Research Site | Oklahoma City | Oklahoma |
| United States | Research Site | Olive Branch | Mississippi |
| United States | Research Site | Phoenix | Arizona |
| United States | Research Site | Pittsburgh | Pennsylvania |
| United States | Research Site | Ponte Vedra | Florida |
| United States | Research Site | Port Charlotte | Florida |
| United States | Research Site | Portland | Maine |
| United States | Research Site | Quincy | Massachusetts |
| United States | Research Site | Raleigh | North Carolina |
| United States | Research Site | Raleigh | North Carolina |
| United States | Research Site | Rapid City | South Dakota |
| United States | Research Site | Rapid City | South Dakota |
| United States | Research Site | Renton | Washington |
| United States | Research Site | Richmond | Virginia |
| United States | Research Site | Rochester | New York |
| United States | Research Site | Saint Louis | Missouri |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | San Diego | California |
| United States | Research Site | Sandusky | Ohio |
| United States | Research Site | Sanford | Florida |
| United States | Research Site | Santa Ana | California |
| United States | Research Site | Santa Rosa | California |
| United States | Research Site | Savannah | Georgia |
| United States | Research Site | Seattle | Washington |
| United States | Research Site | Spring Valley | California |
| United States | Research Site | Sterling | Illinois |
| United States | Research Site | Suffolk | Virginia |
| United States | Research Site | Tacoma | Washington |
| United States | Research Site | Thousand Oaks | California |
| United States | Research Site | Torrance | California |
| United States | Research Site | Towson | Maryland |
| United States | Research Site | Tucson | Arizona |
| United States | Research Site | Tupelo | Mississippi |
| United States | Research Site | Tustin | California |
| United States | Research Site | Ventura | California |
| United States | Research Site | Williamsville | New York |
| United States | Research Site | Winston-Salem | North Carolina |
| United States | Research Site | York | Pennsylvania |
| United States | Research Site | Ypsilanti | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| Amgen |
United States, Australia, Austria, Belgium, Canada, Czechia, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Korea, Republic of, Netherlands, New Zealand, Norway, Poland, Russian Federation, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom,
Hovingh GK, Raal FJ, Dent R, Stefanutti C, Descamps O, Masana L, Lira A, Bridges I, Coll B, Sullivan D. Long-term safety, tolerability, and efficacy of evolocumab in patients with heterozygous familial hypercholesterolemia. J Clin Lipidol. 2017 Nov - Dec; — View Citation
Kasichayanula S, Grover A, Emery MG, Gibbs MA, Somaratne R, Wasserman SM, Gibbs JP. Clinical Pharmacokinetics and Pharmacodynamics of Evolocumab, a PCSK9 Inhibitor. Clin Pharmacokinet. 2018 Jul;57(7):769-779. doi: 10.1007/s40262-017-0620-7. Review. — View Citation
Sattar N, Toth PP, Blom DJ, Koren MJ, Soran H, Uhart M, Elliott M, Cyrille M, Somaratne R, Preiss D. Effect of the Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor Evolocumab on Glycemia, Body Weight, and New-Onset Diabetes Mellitus. Am J Cardiol. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events | Adverse event (AE) severity assessments were made using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grading, version 4.0, where grade 1 = mild AE, grade 2 = moderate AE, Grade 3 = severe AE, grade 4 = life-threatening AE and Grade 5 = death due to AE. | 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period | |
| Secondary | Percent Change From Baseline in LDL-C at Weeks 48 and 104 | Baseline of the parent study and weeks 48 amd 104 | ||
| Secondary | Change From Baseline in LDL-C at Weeks 48 and 104 | Baseline of the parent study and weeks 48 amd 104 |