A Study on The Potential of Aleglitazar to Reduce Cardiovascular Risk in Patients With Stable Cardiovascular Disease and Glucose Abnormalities

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01715818
First received: October 25, 2012
Last updated: September 22, 2014
Last verified: September 2014
  Purpose

This randomized, double-blind, placebo-controlled, parallel group, multicenter s tudy will evaluate the potential of aleglitazar to reduce cardiovascular risk in patients with stable cardiovascular disease and glucose abnormalities. Patients will be randomized 1:1 to receive either aleglitazar 150 mcg orally daily or ma tching placebo.


Condition Intervention Phase
Cardiovascular Disease, Diabetes Mellitus, Type 2
Drug: Placebo
Drug: aleglitazar
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A PHASE 3B STUDY TO EVALUATE THE POTENTIAL OF ALEGLITAZAR TO REDUCE CARDIOVASCULAR RISK IN PATIENTS WITH STABLE CARDIOVASCULAR DISEASE AND GLUCOSE ABNORMALITIES

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Time to first occurrence of any component of the composite event (cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke) as adjudicated by the Clinical Events Committee (CEC) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to first occurrence of a composite with components as adjudicated by the CEC: cardiovascular death, non-fatal MI and non-fatal stroke (in each of the subgroups with or without evidence of T2D at baseline) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Time to first occurrence of a composite with components as adjudicated by the CEC: all-cause mortality, non-fatal MI and non-fatal stroke (in each of the subgroups with or without evidence of T2D at baseline) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 1999
Study Start Date: December 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aleglitazar Drug: aleglitazar
150 mcg orally daily
Placebo Comparator: Placebo Drug: Placebo
matching aleglitazar placebo tablet orally daily

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients with established evidence of stable cardiovascular disease (CVD) defined as at least one of the following groups of criteria (A or B) A. Age >/= 40 years with history with prior CV event of prior myocardial infarction or prior ischemic stroke (confirmed by brain imaging study), with onset >/= 3 months prior to randomization and stable in the Investigator's judgment B. Age >/= 55 years with evidence of CVD (stable in the Investigator's judgment), defined as at least one of the following: Coronary disease, cerebrovascular disease or peripheral arterial disease as defined by protocol
  • Patients with glucose abnormalities based on one of the following A-B criteria:

A. Established Type 2 diabetes mellitus (T2D) according to 2010 ADA criteria; treatment may include diet alone, or any glucose-lowering therapies except for thiazolidinediones (TDZs) B. No fulfillment of criterion A) but evidence of glucose abnormalities

  • Optimal management of CV risk factors including hypertension and dyslipidemia as informed by the best evidence and clinical practice guidelines

Exclusion Criteria:

  • Current treatment with a thiazolidinedione (TDZ) or fibrate
  • Prior intolerance to a TDZ or fibrate
  • Previous participation in a trial with aleglitazar
  • Other types of diabetes
  • Inadequate liver, hematologic or renal function
  • Symptomatic heart failure classified as NYHA class II-IV
  • Hospitalization for a primary diagnosis of heart failure in the 12-month period preceding randomization
  • Peripheral edema which in the judgment of the Investigator in believed to be severe and of cardiac origin
  • History of surgical coronary revascularization (CABG) less than 5 years prior to screening, except in cases of subsequent myocardial infarction
  • Currently scheduled for arterial revascularization procedures
  • Systemic corticosteroid therapy for > 2 weeks within 3 months prior to screening
  • Diagnosed or treated malignancy (except for treated basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01715818

  Hide Study Locations
Locations
United States, Alabama
Muscle Shoals, Alabama, United States, 35662
United States, Arizona
Gilbert, Arizona, United States, 85295
Phoenix, Arizona, United States, 85018
Tucson, Arizona, United States, 85724
United States, California
Cudahy, California, United States, 90201
Encino, California, United States, 91436
Fresno, California, United States, 93720
Fresno, California, United States, 93721
Hawaiian Gardens, California, United States, 90716
Huntington Beach, California, United States, 92646
Lomita, California, United States, 90717
Long Beach, California, United States, 90807
Los Angeles, California, United States, 90017
Los Angeles, California, United States, 90057
Los Angeles, California, United States, 90036
Los Gatos, California, United States, 95032
North Hollywood, California, United States, 91606
Northridge, California, United States, 91325
Roseville, California, United States, 95661
Sacramento, California, United States, 95821
San Diego, California, United States, 92103
Stockton, California, United States, 95207
Thousand Oaks, California, United States, 91360
Torrance, California, United States, 90502
Tustin, California, United States, 92780
Ventura, California, United States, 90265
United States, Colorado
Denver, Colorado, United States, 80209
United States, Florida
Atlantis, Florida, United States, 33462
Bradenton, Florida, United States, 34208
Brooksville, Florida, United States, 34601
Clearwater, Florida, United States, 33755
Clearwater, Florida, United States, 33756
DeLand, Florida, United States, 32720
Fort Lauderdale, Florida, United States, 33316
Hialeah, Florida, United States, 33012
Hialeah, Florida, United States, 33013
Kissimmee, Florida, United States, 34741
Miami, Florida, United States, 33144
Miami, Florida, United States, 33135
Miami Beach, Florida, United States, 33140
New Port Richey, Florida, United States, 34652
Orlando, Florida, United States, 32822
Panama City, Florida, United States, 32401
Pinellas Park, Florida, United States, 33781
Port Charlotte, Florida, United States, 33952
Sarasota, Florida, United States, 34239
St. Petersburg, Florida, United States, 33709
Tampa, Florida, United States, 33613
West Palm Beach, Florida, United States, 33401
Winter Park, Florida, United States, 32789
United States, Georgia
Augusta, Georgia, United States, 30909
Decatur, Georgia, United States, 30030
Dunwoody, Georgia, United States, 30338
United States, Idaho
Eagle, Idaho, United States, 83616
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Melrose Park, Illinois, United States, 60160
United States, Indiana
Brownsburg, Indiana, United States, 46112
Evansville, Indiana, United States, 47714
Valparaiso, Indiana, United States, 46383
United States, Iowa
Council Bluffs, Iowa, United States, 51501
Iowa City, Iowa, United States, 52242
United States, Kansas
Wichita, Kansas, United States, 67203
United States, Kentucky
Lexington, Kentucky, United States, 40504
Louisville, Kentucky, United States, 40213
Owensboro, Kentucky, United States, 42303
United States, Louisiana
Alexandria, Louisiana, United States, 71301
United States, Maine
Bangor, Maine, United States, 04401
United States, Maryland
Baltimore, Maryland, United States, 21209
Baltimore, Maryland, United States, 21215
Baltimore, Maryland, United States, 21201
Oxon Hill, Maryland, United States, 20745
United States, Michigan
Traverse City, Michigan, United States, 49684
United States, Mississippi
Fall Rivers, Mississippi, United States, 02720
Haverhill, Mississippi, United States, 01830
United States, Missouri
Kansas City, Missouri, United States, 64111
United States, Nebraska
Bellevue, Nebraska, United States, 68005
Fremont, Nebraska, United States, 68025
United States, Nevada
Las Vegas, Nevada, United States, 89123
Las Vegas, Nevada, United States, 89106
Las Vegas, Nevada, United States, 89121
United States, New Jersey
Elizabeth, New Jersey, United States, 07202
United States, New York
Albany, New York, United States, 12206-1098
North Massapequa, New York, United States, 11758
Smithtown, New York, United States, 11787
Syracuse, New York, United States, 13202
Westfield, New York, United States, 14787
United States, North Carolina
Elizabeth City, North Carolina, United States, 27909
Morganton, North Carolina, United States, 28655
Raleigh, North Carolina, United States, 27609
Shelby, North Carolina, United States, 28150
Winston-Salem, North Carolina, United States, 27103
United States, North Dakota
Fargo, North Dakota, United States, 58103
United States, Ohio
Akron, Ohio, United States, 44313
Gallipolis, Ohio, United States, 45631
Kettering, Ohio, United States, 45429
Zanesville, Ohio, United States, 43701
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73103
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Portland, Oregon, United States, 97220
United States, Pennsylvania
Beaver, Pennsylvania, United States, 15009
Doylestown, Pennsylvania, United States, 18901
Fleetwood, Pennsylvania, United States, 19522
Harleysville, Pennsylvania, United States, 19438
Jersey Shore, Pennsylvania, United States, 17740
Lansdale, Pennsylvania, United States, 19446
Philadelphia, Pennsylvania, United States, 19114
Pittsburg, Pennsylvania, United States, 15202
Sellersville, Pennsylvania, United States, 18960
Uniontown, Pennsylvania, United States, 15401
United States, South Carolina
Clinton, South Carolina, United States, 29325
Greer, South Carolina, United States, 29651
Murrells Inlet, South Carolina, United States, 29576
Varnville, South Carolina, United States, 29944
United States, South Dakota
Dakota Dunes, South Dakota, United States, 57049
United States, Tennessee
Chattanooga, Tennessee, United States, 37404-3230
Chattanooga, Tennessee, United States, 37411
Jackson, Tennessee, United States, 38305
Knoxville, Tennessee, United States, 27912
Nashville, Tennessee, United States, 37203
United States, Texas
Arlington, Texas, United States, 76012
Corpus Christi, Texas, United States, 78404
Dallas, Texas, United States, 75230
El Paso, Texas, United States, 79925
Houston, Texas, United States, 77030
Houston, Texas, United States, 77036
Houston, Texas, United States, 77074
Kingwood, Texas, United States, 77339
McAllen, Texas, United States, 78501
New Braunfels, Texas, United States, 78130
North Richland Hills, Texas, United States, 76180
San Antonio, Texas, United States, 78224
San Antonio, Texas, United States, 78229
Tyler, Texas, United States, 75701
United States, Utah
Bountiful, Utah, United States, 84010
Draper, Utah, United States, 84020
Murray, Utah, United States, 84123
Salt Lake City, Utah, United States, 84124
United States, Virginia
Burke, Virginia, United States, 22015
Manassas, Virginia, United States, 20110
Suffolk, Virginia, United States, 23435
United States, Washington
Port Orchard, Washington, United States, 98366
Spokane, Washington, United States, 99207
United States, Wisconsin
Madison, Wisconsin, United States, 53719
Argentina
Caba, Argentina, C1428DCO
Caba, Argentina, C1119ACN
Australia, New South Wales
Camperdown, New South Wales, Australia, 2050
Gosford, New South Wales, Australia, 2250
Kogarah, New South Wales, Australia, 2217
Wollongong, New South Wales, Australia, 2500
Australia, Queensland
South Brisbane, Queensland, Australia, 4101
Australia, South Australia
Adelaide, South Australia, Australia, 5000
Woodville, South Australia, Australia, 5011
Australia, Tasmania
Launceston, Tasmania, Australia, 7250
Australia, Victoria
Geelong, Victoria, Australia, 3220
Heidelberg, Victoria, Australia, 3081
Melbourne, Victoria, Australia, 3004
Australia, Western Australia
Armadale, Western Australia, Australia, 6112
Perth, Western Australia, Australia, 6009
Austria
Braunau, Austria, 5280
Feldkirch, Austria, 6800
Graz, Austria, 8036
Wien, Austria, 1130
Canada, British Columbia
Kelowna, British Columbia, Canada, V1Y 1E4
Surrey, British Columbia, Canada, V3V 1Z2
Canada, Manitoba
Winnipeg, Manitoba, Canada, R3E 3P4
Canada, New Brunswick
Bathurst, New Brunswick, Canada, E2A 4X7
Canada, Ontario
Cambridge, Ontario, Canada, N1R 6V6
Collingwood, Ontario, Canada, L9Y 1W3
Hamilton, Ontario, Canada, L8L 2X2
London, Ontario, Canada, N5W 6A2
London, Ontario, Canada, N6G 0J4
New Market, Ontario, Canada, L3Y 5G8
NewMarket, Ontario, Canada, L3Y 8C3
Sarnia, Ontario, Canada, N7T 4X3
Sudbury, Ontario, Canada, P3C 5K7
Toronto, Ontario, Canada, M5G 2C4
Toronto, Ontario, Canada, M9V 4B4
Canada, Prince Edward Island
Quebec, Prince Edward Island, Canada, G1V 4G2
Canada, Quebec
Chicoutimi, Quebec, Canada, G7H 5H6
Chicoutimi, Quebec, Canada, G7H 7Y8
Granby, Quebec, Canada, J2G 8Z9
Lachine, Quebec, Canada, H8S 2E4
Laval, Quebec, Canada, H7M 3L9
Longueuil, Quebec, Canada, J4M 2X1
Montreal, Quebec, Canada, H1T 3Y7
Montreal, Quebec, Canada, H3G 1A4
Montreal, Quebec, Canada, H1T 1C8
Montreal, Quebec, Canada, H2P 2M1
Montréal, Quebec, Canada, H4N 2W2
Sherbrooke, Quebec, Canada, J1H 5N4
St-Charles Borromee, Quebec, Canada, J6E 6J2
St-Lambert, Quebec, Canada, J4P 2H4
St. Jerome, Quebec, Canada, J7Z 5T3
Ste-Foy, Quebec, Canada, G1W 4R4
Terrebonne, Quebec, Canada, J6V 1S8
Canada, Saskatchewan
Saskatoon, Saskatchewan, Canada, S7K 3H3
Canada
Quebec, Canada, G3K 2P8
Chile
Las Condes, Chile, 7500710
Santiago, Chile, 7500347
Santiago, Chile, 7500710
Santiago, Chile, 7500010
Temuco, Chile, 4813299
Temuco, Chile, 4781156
Temuco, Chile, 4790869
Colombia
Barranquila, Colombia
Barranquilla, Colombia
Bogota, Colombia
Bogotá, Colombia
Cartagena, Colombia
Floridablanca, Colombia
Medellin, Colombia
Czech Republic
Beroun, Czech Republic, 266 01
Brno, Czech Republic, 601 77
Brno, Czech Republic, 625 00
Jihlava, Czech Republic, 586 33
Liberec, Czech Republic, 460 63
Praha, Czech Republic, 150 30
Praha 10, Czech Republic, 100 34
Praha 2, Czech Republic, 128 08
Praha 4, Czech Republic, 140 21
Praha 4, Czech Republic, 140 59
Praha 4, Czech Republic, 149 00
Praha 4 - Krc, Czech Republic, 140 59
Praha 5, Czech Republic, 158 00
Praha 5, Czech Republic, 150 06
Slany, Czech Republic, 274 51
Trebic, Czech Republic, 674 01
Estonia
Narva, Estonia, 20307
Tallinn, Estonia, 10138
Tartu, Estonia, 51014
Tartu, Estonia, 50410
Germany
Berlin, Germany, 10117
Berlin, Germany, 13125
Berlin, Germany, 13353
Berlin-Charlottenburg, Germany, 14050
Bochum, Germany, 44787
Chemnitz, Germany, 09111
Damme, Germany, 49401
Dresden, Germany, 01067
Frankfurt, Germany, 60596
Frankfurt, Germany, 65929
Hannover, Germany, 30159
Homburg, Germany, 66421
Kassel, Germany, 34121
Koethen, Germany, 06366
Köln, Germany, 50937
Leipzig, Germany, 04103
Magdeburg, Germany, 39104
Moenchengladbach, Germany, 41063
Münster, Germany, 48145
Neunkirchen, Germany, 66539
Wangen, Germany, 88239
Hungary
Balatonfuered, Hungary, 8230
Budapest, Hungary, 1036
Budapest, Hungary, 1023
Budapest, Hungary, 1027
Budapest, Hungary, 1196
Budapest, Hungary, 1125
Budapest, Hungary, 1085
Budapest, Hungary, 1131
Debrecen, Hungary, 4032
Gyöngyös, Hungary, 3200
Mosonmagyarovar, Hungary, 9200
Nyíregyháza, Hungary, 4400
Papa, Hungary, 8500
Szeged, Hungary, 6720
Szekesfehervar, Hungary, 8000
Szolnok, Hungary, 5004
Zalaegerszeg, Hungary, 8900
Israel
Givatayim, Israel, 53583
Italy
Naples, Campania, Italy, 80122
Napoli, Campania, Italy, 80131
Bologna, Emilia-Romagna, Italy, 40133
Roma, Lazio, Italy, 00128
Rome, Lazio, Italy, 00185
Milano, Lombardia, Italy, 20138
Milano, Lombardia, Italy, 20132
Pavia, Lombardia, Italy, 27100
Pesaro, Marche, Italy, 61121
Catania, Sicilia, Italy, 95122
Palermo, Sicilia, Italy, 90127
Massa, Toscana, Italy, 54100
Japan
Tochigi, Japan, 329-0498
Korea, Republic of
Busan, Korea, Republic of, 602-715
Busan, Korea, Republic of, 602-739
Daejeon, Korea, Republic of, 301-721
Goyang-si, Korea, Republic of, 411-706
Gwangju, Korea, Republic of, 501-757
Gyeonggi-Do, Korea, Republic of, 431-070
Gyeonggi-do, Korea, Republic of, 443-380
Gyeonggi-do, Korea, Republic of, 480-717
Gyeonggi-do, Korea, Republic of, 410-773
Incheon, Korea, Republic of, 405-760
Seoul, Korea, Republic of, 135-720
Seoul, Korea, Republic of, 156-707
Seoul, Korea, Republic of, 143-729
Seoul, Korea, Republic of, 137-701
Seoul, Korea, Republic of, 130-872
Suwon-si,, Korea, Republic of, 442-723
Wonju, Korea, Republic of, 220-701
Latvia
Liepaja, Latvia, 3400
Riga, Latvia, LV-1058
Riga, Latvia, LV-1002
Riga, Latvia, LV-1024
Riga, Latvia, LV-1012
Lithuania
Kaunas, Lithuania, 50184
Kaunas, Lithuania, LT-47144
Kaunas, Lithuania, 48259
Vilnius, Lithuania, LT-02169
Malaysia
Johor, Malaysia, 80100
Kuala Lumpur, Malaysia, 59100
Perak, Malaysia, 34000
Sabah, Malaysia, 88300
Sarawak, Malaysia, 94300
Selangor, Malaysia, 68100
Mexico
Aguascalientes, Mexico, 20234
Mexico, Mexico, 03300
Monclova, Mexico, 25750
Monterrey, Mexico, 64460
Xalapa, Mexico, 91020
Poland
Bialystok, Poland, 15-276
Gdynia, Poland, 81-384
Gdynia, Poland, 81-472
Katowice, Poland, 40-954
Katowice, Poland, 40-748
Krakow, Poland, 30-082
Krakow, Poland, 31-202
Krakow, Poland, 31-261
Krakow, Poland, 30-015
Lodz, Poland, 90-242
Lublin, Poland, 20-093
Lublin, Poland, 20-044
Nowy Sacz, Poland, 33-300
Opole, Poland, 45-367
Rzeszow, Poland, 35-055
Warsawa, Poland, 01-192
Wroclaw, Poland, 50-088
Romania
Baia Mare, Romania, 430123
Bucharest, Romania, 010507
Bucharest, Romania, 061119
Bucharest, Romania, 800578
Bucuresti, Romania, 010825
Bucuresti, Romania, 020359
Bucuresti, Romania, 050098
Craiova, Romania, 200642
Oradea, Romania, 410169
Ploiesti, Romania, 100163
Targu-Mures, Romania, 540124
Russian Federation
Kemerovo, Russian Federation
Saint Petersburg, Russian Federation, 199034
Tomsk, Russian Federation, 634012
South Africa
Pretoria, South Africa, 0103
Pretoria-West, South Africa, 0183
Spain
San Juan de Alicante, Alicante, Spain, 3550
Palma de Mallorca, Islas Baleares, Spain, 07014
Santiago de Compostela, La Coruña, Spain, 15706
Lleida, Lerida, Spain, 25198
Málaga, Malaga, Spain, 29009
Seville, Sevilla, Spain, 41009
Alzira, Valencia, Spain, 46600
Albacete, Spain, 02006
Almeria, Spain, 04009
Barcelona, Spain, 08003
Barcelona, Spain
Barcelona, Spain, 08907
Barcelona, Spain, 08036
Barcelona, Spain, 08035
Girona, Spain, 17007
Granada, Spain, 18012
Huelva, Spain, 21005
Madrid, Spain, 41013
Malaga, Spain, 29010
Malaga, Spain, 29006
Tarragona, Spain, 43007
Valencia, Spain, 46014
Sweden
Malmö, Sweden, 205 02
Stockholm, Sweden, 111 35
Stockholm, Sweden, 113 61
Stockholm, Sweden, 171 76
Thailand
Bangkok, Thailand, 10330
Khon Kaen, Thailand, 40002
United Kingdom
Birmingham, United Kingdom, B15 2SQ
Cardiff, United Kingdom, CF14 5GJ
Chorley, United Kingdom, PR7 7NA
Edinburgh, United Kingdom, EH16 4TJ
Glasgow, United Kingdom, G12 8QQ
Glasgow, United Kingdom, G20 0SP
Inverness, United Kingdom, IV2 4AG
Liverpool, United Kingdom, L22 0LG
Liverpool, United Kingdom, L9 7AL
Manchester, United Kingdom, M15 6SX
Mortimer, United Kingdom, RG7 3SQ
Reading, United Kingdom, RG2 0TG
Soham, Ely, United Kingdom, CB7 5JD
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01715818     History of Changes
Other Study ID Numbers: BC28027, 2012-000671-16
Study First Received: October 25, 2012
Last Updated: September 22, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Cardiovascular Diseases
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 30, 2014