Trial information

A Study of RO4607381 in Stable Coronary Heart Disease Patients With Recent Acute Coronary Syndrome

Status: Recruiting

Protocol number: NC20971

Sponsor: Hoffmann-La Roche

Company division: Pharmaceutical

Official Scientific Title: A randomized, double-blind, placebo-controlled study assessing the effect of RO4607381 on cardiovascular mortality and morbidity in clinically stable patients with a recent acute coronary syndrome

Brief summary: This study will evaluate the potential of RO4607381 to reduce cardiovascular morbidity and mortality in stable coronary heart disease patients with recent Acute Coronary Syndrome (ACS) and evaluate the long term safety profile of the drug. Eligible patients in stable condition will be randomized to receive either RO4607381 600mg po or placebo po, daily, together with a background of standard medication for ACS (including aspirin, antihypertensives and statins). The anticipated time on study treatment is 2+ years, and the target sample size is 500+ individuals. Target sample size is 15600.

Study phase: III

Study type: Interventional; Treatment; Randomized; Double Blind; Placebo; Parallel; Safety/Efficacy study

Condition: Coronary Heart Disease

Intervention type: Drug

Intervention name: RO4607381

Primary outcome: 1. Time to first occurrence of any component of the composite cardiovascular event (cardiovascular mortality and morbidity) Time frame: Event driven

Key secondary outcomes: 1. Composite endpoint:all cause mortality Time frame: Event driven 2. Change from baseline in blood lipids and lipoprotein levels Time frame: Throughout study 3. Adverse events, lab parameters, vital signs, ECG Time frame: Throughout study

Inclusion criteria:

• adult patients, >=45 years of age;
• recently hospitalized for ACS;
• clinically stable;
• receiving evidence-based medical and dietary management of dyslipidemia.

Exclusion criteria:

• uncontrolled diabetes;
• clinically unstable;
• severe anemia;
• uncontrolled hypertension;
• concomitant treatment with any other drug raising HDL-C (eg niacin, fibrates).

Gender: Males or Females

Age limits: Min: 45 Years Max: N/A (No limit)

Accepts healthy volunteers: No

Anticipated start date: April, 2008

Trial registration date: 03/28/2008

Date last updated: 8/29/2008

Link to trial result

This trial is being conducted at the following locations:

Argentina

• Almirante Brown
• Bahia Blanca
• Buenos Aires
• Capital Federal
• Ciudad Autónoma De Bs. As.
• Cordoba
• Córdoba
• Coronel Suarez
• Corrientes
• Florida
• Formosa
• Junin
• La Plata
• Mar Del Plata
• Mendoza
• Neuquen
• Quilmes
• Río Negro
• Rosario
• Salta
• San Isidro
• San Justo
• San Luis
• San Martin
• San Miguel De Tucuman
• San Nicolas
• San Salvador De Jujuy
• San Vicente
• Santa Fe
• Tucuman
• Zarate

Australia

• Bedford Park
• Box Hill
• Coffs Harbour
• Concord
• Epping
• Geelong
• Liverpool
• Milton
• Nedlands
• Newcastle
• Perth
• Sale
• Woden, Act
• Woodville
• Woolloongabba

Austria

• Feldkirch
• Graz
• Linz
• Wien

Belgium

• Aalst
• Brugge
• Brussels
• Genk
• Gent
• La Louviere
• Roeselare
• Tienen

Brazil

• Aracaju
• Belo Horizonte
• Brasilia
• Brasília
• Campina Grande Do Sul
• Campinas
• Campo Grande
• Capminas
• Curitiba
• Fortaleza
• Goiania
• Maceio
• Marilia
• Natal
• Olinda
• Pelotas
• Porto Alegre
• Porto Alegre Canoas
• Recite
• Ribeirao Preto
• Rio De Janeiro
• Salvador
• Santo Andre
• Sao Jose do Rio Preto
• Sao Paulo
• São Paulo
• Uberlândia

Canada

• Calgary, AB
• Edmonton, AB
• Nanaimo, BC
• New Westminster, BC
• Surrey, BC
• Vancouver, BC
• Victoria, BC
• Winnipeg, MB
• Moncton, NB
• Mount Pearl
• St John'S
• St. John'S
• Halifax, NS
• Ajax, ON
• Brampton, ON
• Burlington, ON
• Cambridge, ON
• Hamilton, ON
• Kingston, ON
• Mississauga, ON
• Newmarket, ON
• Oshawa, ON
• Sudbury, ON
• Thunder Bay, ON
• Toronto, ON
• Gatineau, QC
• Granby, QC
• Greenfield Park, QC
• Longueuil, QC
• Montreal, QC
• Quebec City, QC
• Sainte-Foy, QC
• Sherbrooke, QC
• St. Georges-De-Beauce, QC
• St-Charles-Borromée, QC
• St-Jerome, QC
• Terrebonne, QC
• Trois-Rivières, QC
• Val D'Or, QC
• Westmount, QC
• Saskatoon, SK

China

• Beijing
• Changchun
• Changchun City, Jilin Province
• Changsha
• Changzhou City
• Chengdu
• Dalian
• Daqing City
• Guangdong Province
• Guangzhou
• Haikou
• Hangzhou
• Heilongjiang
• Jiangxi
• Jinan
• Jindrichuv Hradec
• Lanzhou
• Nanchang
• Nanchang City
• Nanjing
• Shanghai
• Shenyan
• Shenyang
• Shijiazhuang
• Suzhou
• Suzhou City
• Wenzhou
• Wuhan
• Xian
• Xian City

Czech Republic

• Brno
• Ceské Budejovice
• Chrudim
• Hradec Kralove
• Karlovy Vary
• Mestec Kralove
• Ostrava - Fifejdy
• Pardubice
• Prague 2
• Prague 5
• Praha
• Praha 10
• Praha 4
• Praha 5
• Semily
• Tabor
• Trutnov
• Zlin
• Znojmo

Denmark

• Frederiksberg
• Hellerup
• Herlev
• Hillerød
• København
• Køge
• Kolding
• Roskilde
• Svendborg

France

• Angers Cedex 1
• Bron
• Colmar
• Dijon
• Douai
• Lagny Sur Marne
• Marseille
• Marseille Cedex 08
• Mulhouse
• Paris
• Paris Cedex 12
• Paris Cedex 18
• Pessac
• Poitiers
• Saint Herblain (Nantes)
• Strasbourg
• Toulouse Cedex 9
• Tourcoinq
• Valenciennes
• Vandoeuvre Les Nancy

Germany

• Bad Krozingen
• Bad Segeberg
• Berlin
• Bochum
• Burg
• Darmstadt
• Dortmund
• Duisburg
• Frankfurt Am Main
• Fuerth
• Halle
• Hamburg
• Heidelberg
• Heidenheim
• Homburg / Saar
• Langen
• Limburg
• Mannheim
• Moenchengladbach
• Neuss
• Ruedersdorf
• Ulm
• Witten
• Wuppertal

Hungary

• Bekesosaba
• Budapest
• Debrecen
• Kalocsa
• Pecs
• Szeged
• Székesfehérvár
• Zalaegerszeg

Ireland

• Dublin

Israel

• Afula
• Beer Sheva
• Givatayim
• Hadera
• Haifa
• Jerusalem
• Kfar Saba
• Nahariya
• Nazareth
• Netanya
• Petach Tikva
• Petach-Tikva
• Ramat Gan
• Rehovot
• Tel Aviv
• Tiberias
• Zerifin

Italy

• Bergamo
• Caserta
• Castelnuovo
• Chieti
• Cittadella
• Colleferro
• Como
• Forli
• Milano
• Modena
• Napoli
• Novara
• Padova
• Pavia
• Pesaro
• Reggio Emilia
• Roma
• Rozzano
• S. Bonifacio
• Torino
• Treviso
• Udine

Korea, Republic of

• Busan
• Cheonan
• Daegu
• Gangwon-Do
• Gyeonggi-Do
• Incheon
• Kwangju
• Kyunggi Do
• Seoul

Netherlands

• Alkmaar
• Almelo
• Amersfoort
• Amstelveen
• Amsterdam
• Arnhem
• Blaricum
• Breda
• Capelle A/D Ijssel
• Delft
• Den Bosch
• Den Helder
• Deventer
• Eindhoven
• Enschede
• Goes
• Groningen
• Haarlem
• Heerlen
• Hengelo
• Hilversum
• Hoofddorp
• Hoorn
• Leiderdorp
• Maastricht
• Nieuwegein
• Nijmegen
• Oss
• Purmerend
• Rotterdam
• Sneek
• Stadskanaal
• Tilburg
• Utrecht
• Weert
• Zaandam
• Zwolle

New Zealand

• Auckland
• Christchurch
• Dunedin
• Hamilton
• Nelson
• New Plymouth
• Wellington

Poland

• Bialystok
• Bydgoszcz
• Elblag
• Gdynia
• Grodzisk Mazowiecki
• Inowroclaw
• Katowice
• Konin
• Krakow
• Lodz
• Lublin
• Plock
• Poznan
• Pulawy
• Ruda Slaska
• Skierniewice
• Sopot
• Sosnowiec
• Stalowa Wola
• Starachowice
• Swidnik
• Tarnow
• Torun
• Walbrzych
• Warszawa
• Wroclaw
• Zamosc
• Zielona Gora

Romania

• Cordoba

Russian Federation

• Moscow
• Saratov
• St Petersburg
• St. Petersburg
• Tomsk

Slovakia

• Banska Bystrica
• Bratislava
• Dolny Kubin
• Martin
• Nitra
• Rimavska Sobota
• Zilina

South Africa

• Alberton
• Bloemfontein
• Boksburg
• Durban
• Johannesburg
• Kuilsriver
• Lyttelton - Pretoria
• Mossel Bay
• Panorama
• Pinelands
• Pretoria
• Somerset West
• Soweto

Spain

• Alicante
• Barcelona
• Bilbao
• Figueres
• Guadalajara
• La Coruna
• Madrid
• Malaga
• Pamplona
• San Juan De Alicante
• Santander
• Valencia
• Vigo
• Vitoria

Sweden

• Falun
• Göteborg
• Orebro

Switzerland

• Fribourg
• Geneve 14
• Kreuzlingen
• Luzern
• Munsterlingen

United Kingdom

• Airdrie
• Barnet
• Birmingham
• Blackpool
• Bournemouth
• Bradford
• Chertsey
• Edinburgh
• Exeter
• Glasgow
• Leicester
• London
• Luton
• Manchester
• Nottingham
• Nuneaton
• Paisley
• Peterborough
• Southall
• Stirling
• Stockport
• Stoke-on-Trent
• Swansea

United States

• Birmingham, AL
• Mobile, AL
• Tuscaloosa, AL
• Cottonwood, AZ
• Gilbert, AZ
• Lake Havasu City, AZ
• Mesa, AZ
• Phoenix, AZ
• Scottsdale, AZ
• Sierra Vista, AZ
• Tempe, AZ
• Tucson , AZ
• Fayetteville, AR
• Hot Springs, AR
• Jonesboro, AR
• Mountain Home, AR
• Anaheim, CA
• Bakersfield, CA
• Bellflower, CA
• Beverly Hills, CA
• Buena Park, CA
• Carmichael, CA
• Corona, CA
• Encinitas, CA
• Escondido, CA
• Fountain Valley, CA
• Fresno, CA
• Fullerton, CA
• Garden Grove, CA
• Glendale, CA
• Hollywood, CA
• Huntington Beach, CA
• Inglewood, CA
• La Jolla, CA
• La Mesa, CA
• Loma Linda, CA
• Long Beach, CA
• Los Alamitos, CA
• Los Angeles, CA
• Los Banos, CA
• Mission Viejo, CA
• Modesto, CA
• Mountain View, CA
• New Port Beach, CA
• Newport Beach, CA
• Palm Springs, CA
• Pasadena, CA
• Redondo Beach, CA
• Riverside, CA
• Sacramento, CA
• San Diego , CA
• San Dimas, CA
• San Francisco, CA
• San Jose, CA
• Santa Ana, CA
• Santa Rosa, CA
• Simi Valley, CA
• Stockton, CA
• Thousand Oaks, CA
• Torrance , CA
• Van Nuys, CA
• West Hills, CA
• Colorado Springs, CO
• Denver, CO
• Littleton, CO
• Loveland, CO
• Pueblo, CO
• Bridgeport, CT
• Stamford, CT
• Newark, DE
• Washington, DC
• Aventura, FL
• Boynton Beach, FL
• Chipley, FL
• Clearwater, FL
• Crystal River, FL
• Daytona Beach, FL
• Deerfield Beach, FL
• Delray Beach, FL
• Fort Walton Beach, FL
• Ft. Lauderdale, FL
• Gainesville, FL
• Green Cove Springs, FL
• Hollywood, FL
• Hudson, FL
• Jacksonville, FL
• Jupiter, FL
• Kissimmee, FL
• Largo, FL
• Marianna, FL
• Melbourne, FL
• Miami, FL
• Ocala, FL
• Orlando, FL
• Ormond Beach, FL
• Pensacola, FL
• Plantation, FL
• Port Charlotte, FL
• Safety Harbor, FL
• Sarasota , FL
• Spring Hill, FL
• St. Petersburg, FL
• Tallahassee, FL
• Tamarac, FL
• Tampa, FL
• West Palm Beach, FL
• Atlanta, GA
• Columbus, GA
• Covington, GA
• Monroe, GA
• Savannah, GA
• Waycross, GA
• Honolulu, HI
• Meridian, ID
• Nampa, ID
• Bannockburn, IL
• Chicago, IL
• Evanston, IL
• Hinsdale, IL
• Joliet, IL
• Marrionette Park, IL
• Naperville, IL
• Peoria, IL
• Rockford, IL
• Vernon Hills, IL
• Elkhart, IN
• Evansville, IN
• Hammond, IN
• Indianapolis , IN
• Merrillville, IN
• South Bend, IN
• Ames, IA
• Council Bluffs, IA
• Davenport, IA
• Iowa City, IA
• Waterloo, IA
• West Des Moines, IA
• Kansas City, KS
• Olathe, KS
• Overland Park, KS
• Elizabethtown, KY
• Hazard, KY
• Lexington, KY
• Louisville, KY
• Madisonville, KY
• Owensboro, KY
• Alexandria, LA
• Lake Charles, LA
• Marrero, LA
• Metairie, LA
• Natchitoches, LA
• New Orleans, LA
• Shreveport, LA
• Slidell, LA
• Bangor, ME
• Biddeford, ME
• Portland, ME
• Scarborough, ME
• Baltimore, MD
• Bel Air, MD
• Columbia, MD
• Hagerstown, MD
• Pikesville, MD
• Salisbury, MD
• Towson, MD
• Billerica, MA
• Boston, MA
• E. Bridgewater, MA
• Haverhill, MA
• Hyannis, MA
• Natick, MA
• North Dartmouth, MA
• Pittsfield, MA
• Taunton, MA
• Worcester, MA
• Alpena, MI
• Ann Arbor, MI
• Cadillac, MI
• Dearborn, MI
• Detroit, MI
• Fairfield, MI
• Flint, MI
• Kalamazoo, MI
• Lansing, MI
• Rochester Hills, MI
• Duluth, MN
• Minneapolis, MN
• Rochester, MN
• St. Cloud, MN
• St. Paul, MN
• Gulfport, MS
• Jackson, MS
• Picayune, MS
• Tupelo, MS
• Chesterfield, MO
• Jefferson City, MO
• Kansas City, MO
• St. Louis, MO
• Billings, MT
• Butte, MT
• Great Falls, MT
• Kalispell, MT
• Grand Island, NE
• Lincoln, NE
• Omaha, NE
• Papillion, NE
• Las Vegas, NV
• Lebanon, NH
• Manchester, NH
• Nashua, NH
• Bridgewater, NJ
• East Orange, NJ
• Edgewater, NJ
• Elizabeth, NJ
• Linden, NJ
• Mine Hill, NJ
• Newark, NJ
• Passaic, NJ
• Ridgewood, NJ
• Summit, NJ
• Toms River, NJ
• Voorhees, NJ
• Westwood, NJ
• Albuquerque, NM
• Bronx, NY
• Brooklyn, NY
• Buffalo, NY
• Flushing, NY
• Jamaica, NY
• Johnson City, NY
• Liverpool, NY
• New Hartford, NY
• New York, NY
• Rochester, NY
• Saratoga Springs, NY
• Stony Brook, NY
• Suffern, NY
• Syracuse, NY
• Troy, NY
• Asheville, NC
• Cary , NC
• Charlotte, NC
• Durham, NC
• Elizabeth City, NC
• Pinehurst, NC
• Raleigh, NC
• Tabor City, NC
• Winston-Salem, NC
• Fargo, ND
• Minot, ND
• Athens, OH
• Canton, OH
• Centerville, OH
• Cincinnati, OH
• Columbus, OH
• Dayton, OH
• Franklin, OH
• Kettering , OH
• Mayfield Heights, OH
• Sandusky, OH
• Springfield, OH
• Thornville, OH
• Toledo, OH
• West Lake, OH
• Willoughby Hills, OH
• Zanesville, OH
• Midwest City, OK
• Oklahoma City, OK
• Bend, OR
• Hillsboro, OR
• Portland, OR
• Abington, PA
• Allentown, PA
• Altoona, PA
• Bryn Mawr, PA
• Camp Hill, PA
• Downington, PA
• Easton, PA
• Erie, PA
• Feasterville, PA
• Havertown, PA
• Hershey, PA
• Lancaster, PA
• Langhorne, PA
• Limerick, PA
• North Wales, PA
• Pittsburgh, PA
• Sayre, PA
• Scranton, PA
• Sellersville, PA
• West Chester, PA
• Wynnewood, PA
• Wyomissing, PA
• Manati, PR
• Ponce, PR
• Rio Grande, PR
• San Juan, PR
• Toa Baja, PR
• Providence, RI
• Charleston, SC
• Greenville, SC
• Greer, SC
• Monck'S Corner, SC
• Spartanburg, SC
• Taylors, SC
• Rapid City, SD
• Sioux Falls, SD
• Bristol, TN
• Jackson, TN
• Johnson City, TN
• Kingsport, TN
• Knoxville, TN
• Lexington, TN
• Nashville, TN
• Oak Ridge, TN
• Tullahoma, TN
• Austin, TX
• Corpus Christi, TX
• Dallas, TX
• Fort Worth, TX
• Galveston, TX
• Houston, TX
• Humble, TX
• Killeen, TX
• Lackland Afb, TX
• Lubbock, TX
• Mdkinney, TX
• Round Rock , TX
• San Antonio, TX
• Tomball, TX
• Tyler, TX
• Victoria, TX
• Layton, UT
• Ogden, UT
• Provo, UT
• Burke, VA
• Danville, VA
• Harrisonburg, VA
• Hopewell, VA
• Norfolk , VA
• Richmond, VA
• Roanoke, VA
• Springfield, VA
• Bellevue, WA
• Monroe, WA
• Selah, WA
• Spokane , WA
• Tacoma, WA
• Clarksburg, WV
• Madison, WI
• Milwaukee, WI