Clinical trial NCT01516541: A Study of Dalcetrapib in Patients With Stable Coronary Heart Disease, With Coronary Heart Disease Risk Equivalents or at Elevated Risk for Cardiovascular Disease
Official title: 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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiovascular Disease, Coronary Heart Disease, Dyslipidemia, Peripheral Arterial Disease (PAD)
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-01-25
Enrollment: 2220
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Time to first occurrence of any component of the composite cardiovascular event (cardiovascular mortality and morbidity)
timeFrame: approximately 4 years
Secondary outcomes:
measure: All cause mortality
timeFrame: approximately 4 years
measure: Safety: Incidence of adverse events
timeFrame: approximately 4 years
measure: Change in blood lipid and lipoprotein levels
timeFrame: from baseline to 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Anaheim
country: United States
state: California
city: Fullerton
country: United States
state: California
city: San Diego
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Santa Rosa
country: United States
state: California
city: Torrance
country: United States
state: California
city: Torrance
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Lonetree
country: United States
state: Colorado
city: Bridgeport
country: United States
state: Connecticut
city: Hartford
country: United States
state: Connecticut
city: Boynton Beach
country: United States
state: Florida
city: Daytona Beach
country: United States
state: Florida
city: Daytona Beach
country: United States
state: Florida
city: Fort Myers
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Panama City
country: United States
state: Florida
city: Plantation
country: United States
state: Florida
city: Port Charlotte
country: United States
state: Florida
city: Tallahassee
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Covington
country: United States
state: Georgia
city: Cumming
country: United States
state: Georgia
city: Decatur
country: United States
state: Georgia
city: Aurora
country: United States
state: Illinois
city: Rock Island
country: United States
state: Illinois
city: Winfield
country: United States
state: Illinois
city: Elkhart
country: United States
state: Indiana
city: Hammond
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Muncie
country: United States
state: Indiana
city: South Bend
country: United States
state: Indiana
city: Overland Park
country: United States
state: Kansas
city: Louisville
country: United States
state: Kentucky
city: Alexandria
country: United States
state: Louisiana
city: Bangor
country: United States
state: Maine
city: Beltsville
country: United States
state: Maryland
city: Salisbury
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Haverhill
country: United States
state: Massachusetts
city: Hyannis
country: United States
state: Massachusetts
city: North Dartmouth
country: United States
state: Massachusetts
city: Jackson
country: United States
state: Michigan
city: Kalamazoo
country: United States
state: Michigan
city: Marquette
country: United States
state: Michigan
city: Midland
country: United States
state: Michigan
city: Rochester Hills
country: United States
state: Michigan
city: Saginaw
country: United States
state: Michigan
city: Ypsilanti
country: United States
state: Michigan
city: Rochester
country: United States
state: Minnesota
city: St. Cloud
country: United States
state: Minnesota
city: Chesterfield
country: United States
state: Missouri
city: Columbia
country: United States
state: Missouri
city: Kansas City
country: United States
state: Missouri
city: Kalispell
country: United States
state: Montana
city: Nashua
country: United States
state: New Hampshire
city: Camden
country: United States
state: New Jersey
city: Haddon Heights
country: United States
state: New Jersey
city: Mine Hill
country: United States
state: New Jersey
city: Wayne
country: United States
state: New Jersey
city: Westwood
country: United States
state: New Jersey
city: Albany
country: United States
state: New York
city: Albany
country: United States
state: New York
city: Bronx
country: United States
state: New York
city: Buffalo
country: United States
state: New York
city: Cortlandt Manor
country: United States
state: New York
city: Poughkeepsi
country: United States
state: New York
city: Saratoga Springs
country: United States
state: New York
city: Smithtown
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Troy
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Elizabeth City
country: United States
state: North Carolina
city: Hickory
country: United States
state: North Carolina
city: Morehead City
country: United States
state: North Carolina
city: Rocky Mount
country: United States
state: North Carolina
city: Statesville
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Mansfield
country: United States
state: Ohio
city: Mentor
country: United States
state: Ohio
city: Thornville
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Zanesville
country: United States
state: Ohio
city: Allentowm
country: United States
state: Pennsylvania
city: Altoona
country: United States
state: Pennsylvania
city: Camp Hill
country: United States
state: Pennsylvania
city: Doylestown
country: United States
state: Pennsylvania
city: Erie
country: United States
state: Pennsylvania
city: Erie
country: United States
state: Pennsylvania
city: Langhorne
country: United States
state: Pennsylvania
city: Lansdale
country: United States
state: Pennsylvania
city: North Wales
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pottstown
country: United States
state: Pennsylvania
city: Tipton
country: United States
state: Pennsylvania
city: West Chester
country: United States
state: Pennsylvania
city: Anderson
country: United States
state: South Carolina
city: Greer
country: United States
state: South Carolina
city: Rapid City
country: United States
state: South Dakota
city: Johnson City
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Humble
country: United States
state: Texas
city: Odessa
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Provo
country: United States
state: Utah
city: Charlottesville
country: United States
state: Virginia
city: Danville
country: United States
state: Virginia
city: Lynchburg
country: United States
state: Virginia
city: Manassas
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Winchester
country: United States
state: Virginia
city: Milton
country: Australia
state: Queensland
city: Geelong
country: Australia
state: Victoria
city: Joondalup
country: Australia
state: Western Australia
city: Coquitlam
country: Canada
state: British Columbia
city: Kelowna
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Moncton
country: Canada
state: New Brunswick
city: Ajax
country: Canada
state: Ontario
city: Barrie
country: Canada
state: Ontario
city: Burlington
country: Canada
state: Ontario
city: Cambridge
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Oakville
country: Canada
state: Ontario
city: Oshawa
country: Canada
state: Ontario
city: Oshawa
country: Canada
state: Ontario
city: Sudbury
country: Canada
state: Ontario
city: Sudbury
country: Canada
state: Ontario
city: Thunder Bay
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Granby
country: Canada
state: Quebec
city: Greenfield Park
country: Canada
state: Quebec
city: Lachine
country: Canada
state: Quebec
city: Longueuil
country: Canada
state: Quebec
city: Longueuil
country: Canada
state: Quebec
city: Mirabel
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Montréal
country: Canada
state: Quebec
city: Montréal
country: Canada
state: Quebec
city: Québec
country: Canada
state: Quebec
city: St-Lambert
country: Canada
state: Quebec
city: Trois-Rivières
country: Canada
state: Quebec
city: Val D'Or
country: Canada
state: Quebec
city: Quebec
country: Canada
city: Beijing
country: China
city: Nanchang
country: China
city: Shijiazhuang
country: China
city: Benatky nad Jizerou
country: Czech Republic
city: Jindrichuv Hradec
country: Czech Republic
city: Ostrava
country: Czech Republic
city: Pardubice
country: Czech Republic
city: Praha 4
country: Czech Republic
city: Slany
country: Czech Republic
city: Trutnov
country: Czech Republic
city: Ballerup
country: Denmark
city: Hvidovre
country: Denmark
city: Vejle
country: Denmark
city: Århus N
country: Denmark
city: Pessac
country: France
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Kisvarda
country: Hungary
city: Komarom
country: Hungary
city: Nagykanizsa
country: Hungary
city: Pecs
country: Hungary
city: Urhida
country: Hungary
city: Aguascalientes
country: Mexico
city: Aguascaliente
country: Mexico
city: Celaya
country: Mexico
city: Chihuahua
country: Mexico
city: Cuernavaca
country: Mexico
city: D. F.
country: Mexico
city: Durango
country: Mexico
city: Guadalajara
country: Mexico
city: Guadalajara
country: Mexico
city: Guadalajara
country: Mexico
city: Mexico City
country: Mexico
city: Monterrey
country: Mexico
city: Monterrey
country: Mexico
city: Pachuca
country: Mexico
city: Queretaro
country: Mexico
city: San Luis Potosi S.L.P.
country: Mexico
city: San Luis Potosí
country: Mexico
city: San Luís Potosí
country: Mexico
city: Tampico
country: Mexico
city: Alkmaar
country: Netherlands
city: Amsterdam
country: Netherlands
city: Apeldoorn
country: Netherlands
city: Breda
country: Netherlands
city: Delft
country: Netherlands
city: Eindhoven
country: Netherlands
city: Eindhoven
country: Netherlands
city: Gouda
country: Netherlands
city: Groningen
country: Netherlands
city: Heerlen
country: Netherlands
city: Hoorn
country: Netherlands
city: Leiden
country: Netherlands
city: Rotterdam
country: Netherlands
city: Rotterdam
country: Netherlands
city: Utrecht
country: Netherlands
city: Velp
country: Netherlands
city: Venlo
country: Netherlands
city: Zoetermeer
country: Netherlands
city: Bialystok
country: Poland
city: Gdansk
country: Poland
city: Gdynia
country: Poland
city: Katowice
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Lublin
country: Poland
city: Lublin
country: Poland
city: Poznan
country: Poland
city: Pulway
country: Poland
city: Ruda Slaska
country: Poland
city: Warsawa
country: Poland
city: Warszawa
country: Poland
city: Almeria
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Birmingham
country: United Kingdom
city: Cardiff
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Liverpool
country: United Kingdom
city: Manchester
country: United Kingdom
city: Reading
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: