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A Study of Dalcetrapib in Patients With Stable Coronary Heart Disease, With Coronary Heart Disease Risk Equivalents or at Elevated Risk for Cardiovascular Disease

1. november 2016 opdateret af: Hoffmann-La Roche

A Phase 3b, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group, Study to Evaluate the Effect of Dalcetrapib 600 mg on Cardiovascular (CV) Events in Adult Patients With Stable Coronary Heart Disease (CHD), CHD Risk Equivalents or at Elevated Risk for Cardiovascular Disease (CVD).

This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the potential of dalcetrapib to reduce cardiovascular morbidity and mortality in patients with stable coronary heart disease (CHD), with CHD risk equivalents or at elevated risk for cardiovascular disease. Eligible patients will be randomized to receive either dalcetrapib 600 mg orally daily or placebo orally daily, on a background of contemporary, guidelines-based medical care. Anticipated time on study treatment is 4 years.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

2220

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Australien
    • Queensland
      • Milton, Queensland, Australien, 4064
    • Victoria
      • Geelong, Victoria, Australien, 3220
    • Western Australia
      • Joondalup, Western Australia, Australien, 6027
  • Canada
      • Quebec, Canada, G1J 1Z4
    • British Columbia
      • Coquitlam, British Columbia, Canada, V3K 3P4
      • Kelowna, British Columbia, Canada, V1Y 1T2
      • Vancouver, British Columbia, Canada, V5Z 1M9
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 4B7
    • Ontario
      • Ajax, Ontario, Canada, L1S 7K8
      • Barrie, Ontario, Canada, L4M 7G1
      • Burlington, Ontario, Canada, L7M 4Y1
      • Cambridge, Ontario, Canada, N1R 7R1
      • London, Ontario, Canada, N6A 5G6
      • Oakville, Ontario, Canada, L6K 3W7
      • Oshawa, Ontario, Canada, L1H 1B9
      • Oshawa, Ontario, Canada, L1J 2K1
      • Sudbury, Ontario, Canada, P3E 2N8
      • Sudbury, Ontario, Canada, P3E 3B8
      • Thunder Bay, Ontario, Canada, P7B 6V4
      • Toronto, Ontario, Canada, M4G 3E8
    • Quebec
      • Granby, Quebec, Canada, J2G 8Z9
      • Greenfield Park, Quebec, Canada, J4V 3G8
      • Lachine, Quebec, Canada, H8S 2E4
      • Longueuil, Quebec, Canada, J4M 2X1
      • Longueuil, Quebec, Canada, J4N 1C2
      • Mirabel, Quebec, Canada, J7J 2K8
      • Montreal, Quebec, Canada, H1T 1C8
      • Montreal, Quebec, Canada, H1T 3Y7
      • Montréal, Quebec, Canada, H3J 2V5
      • Montréal, Quebec, Canada, H2K 4L5
      • Québec, Quebec, Canada, G1V 4M6
      • St-Lambert, Quebec, Canada, J4P 2H4
      • Trois-Rivières, Quebec, Canada, G8T 7A1
      • Val D'Or, Quebec, Canada, J9P 3Y1
  • Danmark
      • Ballerup, Danmark, 2750
      • Hvidovre, Danmark, 2650
      • Vejle, Danmark, 7100
      • Århus N, Danmark, 8200
  • Det Forenede Kongerige
      • Birmingham, Det Forenede Kongerige, B15 2SQ
      • Cardiff, Det Forenede Kongerige, CF14 5GJ
      • Glasgow, Det Forenede Kongerige, G20 0SP
      • Liverpool, Det Forenede Kongerige, L22 0LG
      • Manchester, Det Forenede Kongerige, M15 6SX
      • Reading, Det Forenede Kongerige, RG2 0TG
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294-0007
      • Huntsville, Alabama, Forenede Stater, 35801
    • California
      • Anaheim, California, Forenede Stater, 92801
      • Fullerton, California, Forenede Stater, 92835
      • San Diego, California, Forenede Stater, 92103
      • Santa Ana, California, Forenede Stater, 92704
      • Santa Rosa, California, Forenede Stater, 95405
      • Torrance, California, Forenede Stater, 90509
      • Torrance, California, Forenede Stater, 90503
    • Colorado
      • Colorado Springs, Colorado, Forenede Stater, 80909
      • Denver, Colorado, Forenede Stater, 80218
      • Lonetree, Colorado, Forenede Stater, 80124
    • Connecticut
      • Bridgeport, Connecticut, Forenede Stater, 06606
      • Hartford, Connecticut, Forenede Stater, 06102
    • Florida
      • Boynton Beach, Florida, Forenede Stater, 33472
      • Daytona Beach, Florida, Forenede Stater, 32114
      • Daytona Beach, Florida, Forenede Stater, 32117
      • Fort Myers, Florida, Forenede Stater, 33907
      • Jacksonville, Florida, Forenede Stater, 32216
      • Panama City, Florida, Forenede Stater, 32401
      • Plantation, Florida, Forenede Stater, 33317
      • Port Charlotte, Florida, Forenede Stater, 33952
      • Tallahassee, Florida, Forenede Stater, 32308
      • Tampa, Florida, Forenede Stater, 33613
      • West Palm Beach, Florida, Forenede Stater, 33401
    • Georgia
      • Covington, Georgia, Forenede Stater, 30014
      • Cumming, Georgia, Forenede Stater, 30041
      • Decatur, Georgia, Forenede Stater, 30033
    • Illinois
      • Aurora, Illinois, Forenede Stater, 60504
      • Rock Island, Illinois, Forenede Stater, 61201
      • Winfield, Illinois, Forenede Stater, 60190
    • Indiana
      • Elkhart, Indiana, Forenede Stater, 46617
      • Hammond, Indiana, Forenede Stater, 46320-1942
      • Indianapolis, Indiana, Forenede Stater, 46237
      • Indianapolis, Indiana, Forenede Stater, 46250
      • Muncie, Indiana, Forenede Stater, 47303
      • South Bend, Indiana, Forenede Stater, 46601
    • Kansas
      • Overland Park, Kansas, Forenede Stater, 66215
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40205
    • Louisiana
      • Alexandria, Louisiana, Forenede Stater, 71301
    • Maine
      • Bangor, Maine, Forenede Stater, 04401
    • Maryland
      • Beltsville, Maryland, Forenede Stater, 20705
      • Salisbury, Maryland, Forenede Stater, 21804
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02111
      • Haverhill, Massachusetts, Forenede Stater, 01830
      • Hyannis, Massachusetts, Forenede Stater, 02601
      • North Dartmouth, Massachusetts, Forenede Stater, 02747
    • Michigan
      • Jackson, Michigan, Forenede Stater, 49201
      • Kalamazoo, Michigan, Forenede Stater, 49048
      • Marquette, Michigan, Forenede Stater, 49855
      • Midland, Michigan, Forenede Stater, 48670
      • Rochester Hills, Michigan, Forenede Stater, 48307
      • Saginaw, Michigan, Forenede Stater, 48602
      • Ypsilanti, Michigan, Forenede Stater, 48197
    • Minnesota
      • Rochester, Minnesota, Forenede Stater, 55905-0001
      • St. Cloud, Minnesota, Forenede Stater, 56303
    • Missouri
      • Chesterfield, Missouri, Forenede Stater, 63017
      • Columbia, Missouri, Forenede Stater, 65201
      • Kansas City, Missouri, Forenede Stater, 64111
    • Montana
      • Kalispell, Montana, Forenede Stater, 59901
    • New Hampshire
      • Nashua, New Hampshire, Forenede Stater, 03060
    • New Jersey
      • Camden, New Jersey, Forenede Stater, 08103
      • Haddon Heights, New Jersey, Forenede Stater, 08035
      • Mine Hill, New Jersey, Forenede Stater, 07803
      • Wayne, New Jersey, Forenede Stater, 07470
      • Westwood, New Jersey, Forenede Stater, 07675
    • New York
      • Albany, New York, Forenede Stater, 12211
      • Albany, New York, Forenede Stater, 12206-1098
      • Bronx, New York, Forenede Stater, 10461
      • Buffalo, New York, Forenede Stater, 14215
      • Cortlandt Manor, New York, Forenede Stater, 10567
      • Poughkeepsi, New York, Forenede Stater, 12601
      • Saratoga Springs, New York, Forenede Stater, 12866
      • Smithtown, New York, Forenede Stater, 11787
      • Syracuse, New York, Forenede Stater, 13202
      • Troy, New York, Forenede Stater, 12180
    • North Carolina
      • Asheville, North Carolina, Forenede Stater, 28803
      • Durham, North Carolina, Forenede Stater, 27710
      • Elizabeth City, North Carolina, Forenede Stater, 27909
      • Hickory, North Carolina, Forenede Stater, 28602
      • Morehead City, North Carolina, Forenede Stater, 28557
      • Rocky Mount, North Carolina, Forenede Stater, 27804
      • Statesville, North Carolina, Forenede Stater, 28625
      • Wilmington, North Carolina, Forenede Stater, 28401
    • North Dakota
      • Fargo, North Dakota, Forenede Stater, 58103
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45227
      • Cleveland, Ohio, Forenede Stater, 44195
      • Mansfield, Ohio, Forenede Stater, 44827
      • Mentor, Ohio, Forenede Stater, 44060
      • Thornville, Ohio, Forenede Stater, 43076
      • Toledo, Ohio, Forenede Stater, 43623
      • Zanesville, Ohio, Forenede Stater, 43701
    • Pennsylvania
      • Allentowm, Pennsylvania, Forenede Stater, 18105
      • Altoona, Pennsylvania, Forenede Stater, 16602
      • Camp Hill, Pennsylvania, Forenede Stater, 17011
      • Doylestown, Pennsylvania, Forenede Stater, 18901
      • Erie, Pennsylvania, Forenede Stater, 16550
      • Erie, Pennsylvania, Forenede Stater, 16502
      • Langhorne, Pennsylvania, Forenede Stater, 19047
      • Lansdale, Pennsylvania, Forenede Stater, 19446
      • North Wales, Pennsylvania, Forenede Stater, 19454-2053
      • Philadelphia, Pennsylvania, Forenede Stater, 19114
      • Philadelphia, Pennsylvania, Forenede Stater, 19153
      • Pottstown, Pennsylvania, Forenede Stater, 19464
      • Tipton, Pennsylvania, Forenede Stater, 16684
      • West Chester, Pennsylvania, Forenede Stater, 19380
    • South Carolina
      • Anderson, South Carolina, Forenede Stater, 29621
      • Greer, South Carolina, Forenede Stater, 29651
    • South Dakota
      • Rapid City, South Dakota, Forenede Stater, 57701
    • Tennessee
      • Johnson City, Tennessee, Forenede Stater, 37604
    • Texas
      • Dallas, Texas, Forenede Stater, 75251
      • Humble, Texas, Forenede Stater, 77338
      • Odessa, Texas, Forenede Stater, 79761
      • Tyler, Texas, Forenede Stater, 75701
    • Utah
      • Provo, Utah, Forenede Stater, 84004
    • Virginia
      • Charlottesville, Virginia, Forenede Stater, 22908
      • Danville, Virginia, Forenede Stater, 24541-4160
      • Lynchburg, Virginia, Forenede Stater, 24501
      • Manassas, Virginia, Forenede Stater, 20109
      • Richmond, Virginia, Forenede Stater, 23249
      • Winchester, Virginia, Forenede Stater, 22601
  • Frankrig
      • Pessac, Frankrig, 33604
  • Holland
      • Alkmaar, Holland, 1815 JD
      • Amsterdam, Holland, 1105 AZ
      • Apeldoorn, Holland, 7334 DZ
      • Breda, Holland, 4818 CK
      • Delft, Holland, 2625 AD
      • Eindhoven, Holland, 5611 NJ
      • Eindhoven, Holland, 5632 EJ
      • Gouda, Holland, 2803 HH
      • Groningen, Holland, 9711 SG
      • Heerlen, Holland, 6419 PC
      • Hoorn, Holland, 1624 NP
      • Leiden, Holland, 2300 RC
      • Rotterdam, Holland, 3045 PM
      • Rotterdam, Holland, 3021 HC
      • Utrecht, Holland, 3584 CX
      • Velp, Holland, 6883 ES
      • Venlo, Holland, 5912 BL
      • Zoetermeer, Holland, 2724 EK
  • Kina
      • Beijing, Kina, 100050
      • Nanchang, Kina, 330006
      • Shijiazhuang, Kina, 050035
  • Mexico
      • Aguascaliente, Mexico, 20230
      • Aguascalientes, Mexico, 20230
      • Celaya, Mexico, 38000
      • Chihuahua, Mexico, 31217
      • Cuernavaca, Mexico, 62250
      • D. F., Mexico, 14380
      • Durango, Mexico, 34080
      • Guadalajara, Mexico, 44650
      • Guadalajara, Mexico, 44670
      • Guadalajara, Mexico, 44600
      • Mexico City, Mexico, 11650
      • Monterrey, Mexico, 64060
      • Monterrey, Mexico, 64020
      • Pachuca, Mexico, 42086
      • Queretaro, Mexico, 76000
      • San Luis Potosi S.L.P., Mexico, 78240
      • San Luis Potosí, Mexico, 78200
      • San Luís Potosí, Mexico, 78200
      • Tampico, Mexico, 89000
  • Polen
      • Bialystok, Polen, 15-879
      • Gdansk, Polen, 80-286
      • Gdynia, Polen, 81-384
      • Katowice, Polen, 40-748
      • Krakow, Polen, 30-069
      • Lodz, Polen, 91-425
      • Lodz, Polen, 90-302
      • Lublin, Polen, 20-044
      • Lublin, Polen, 20-015
      • Lublin, Polen, 20-538
      • Poznan, Polen, 61-655
      • Pulway, Polen, 24-100
      • Ruda Slaska, Polen, 41-709
      • Warsawa, Polen, 01-192
      • Warszawa, Polen, 02-097
  • Spanien
      • Almeria, Spanien, 04009
      • Barcelona, Spanien, 08003
      • Madrid, Spanien, 28009
      • Madrid, Spanien, 280146
      • Malaga, Spanien, 29010
  • Tjekkiet
      • Benatky nad Jizerou, Tjekkiet, 29471
      • Jindrichuv Hradec, Tjekkiet, 377 01
      • Ostrava, Tjekkiet, 722 00
      • Pardubice, Tjekkiet, 530 02
      • Praha 4, Tjekkiet, 140 00
      • Slany, Tjekkiet, 274 01
      • Trutnov, Tjekkiet, 541 01
  • Ungarn
      • Budapest, Ungarn, 1133
      • Budapest, Ungarn, 1036
      • Debrecen, Ungarn, 4025
      • Kisvarda, Ungarn, 4600
      • Komarom, Ungarn, 2900
      • Nagykanizsa, Ungarn, 8800
      • Pecs, Ungarn, 7621
      • Urhida, Ungarn, 8142

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

45 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Adult patients, >/= 45 years of age
  • Established cardiovascular disease A stable coronary disease B cerebrovascular disease C peripheral artery disease
  • Without established coronary disease D pharmacologically treated type 2 diabetes mellitus and one or more risk factor(s) for cardiovascular disease E 3 or more risk factors for cardiovascular disease
  • Receiving evidence-based medical and dietary management of dyslipidemia

Exclusion Criteria:

  • Occurrence of myocardial infarction, hospitalization for unstable angina, stroke or revascularization (coronary, carotid or peripheral) within three months prior to randomization
  • Uncontrolled hypertension
  • Uncontrolled diabetes
  • Concomitant treatment with any other drug raising HDL-C
  • Previous treatment with compounds targeting cholesteryl ester transfer protein (CETP)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Dalcetrapib
Dalcetrapib 600 mg orally daily on a background of contemporary, guidelines-based medical care.
Andet: Background care
Guidelines-based medical care
Medicin: dalcetrapib
600 mg orally daily
Placebo komparator: Placebo
Placebo orally daily, on a background of contemporary, guidelines-based medical care.
Andet: Background care
Guidelines-based medical care
Medicin: Placebo
Matching dalcetrapib placebo orally daily

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Time to first occurrence of any component of the composite cardiovascular event (cardiovascular mortality and morbidity)
Tidsramme: approximately 4 years
approximately 4 years

Sekundære resultatmål

Resultatmål
Tidsramme
Sikkerhed: Forekomst af uønskede hændelser
Tidsramme: cirka 4 år
cirka 4 år
All cause mortality
Tidsramme: approximately 4 years
approximately 4 years
Change in blood lipid and lipoprotein levels
Tidsramme: from baseline to 12 months
from baseline to 12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hoffmann-La Roche

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2012

Primær færdiggørelse (Faktiske)

1. juli 2012

Studieafslutning (Faktiske)

1. juli 2012

Datoer for studieregistrering

Først indsendt

13. januar 2012

Først indsendt, der opfyldte QC-kriterier

24. januar 2012

Først opslået (Skøn)

25. januar 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

2. november 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. november 2016

Sidst verificeret

1. november 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NC25608
  • 2011-001891-21 (EudraCT nummer)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Background care

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Lebanon

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner