A Study With Aleglitazar in Patients With a Recent Acute Coronary Syndrome and Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01042769
First received: January 5, 2010
Last updated: September 22, 2014
Last verified: September 2014
  Purpose

This double-blind, parallel, two-arm study will evaluate the potential to reduce cardiovascular risk, the tolerability and long-term safety profile of aleglitaz ar compared to placebo on top of standard care in patients with recent acute cor onary syndrome (ACS) and type 2 diabetes mellitus. Patients will be randomized t

o receive either aleglitazar or placebo once daily as oral doses. The study will last until at least 950 events occur, but time on study treatment will be for a t least 2.5 years.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Aleglitazar
Drug: Placebo
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 Safety and Efficacy Study to Evaluate the Potential of Aleglitazar to Reduce Cardiovascular Risk in Coronary Heart Disease (CHD) Patients With a Recent Acute Coronary Syndrome (ACS) Event and Type 2 Diabetes Mellitus (T2D)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Effect on cardiovascular death, non-fatal myocardial infarction and non-fatal stroke [ Time Frame: Throughout study, approximately 4.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerability and long-term safety profile [ Time Frame: Throughout study, approximately 4.5 years ] [ Designated as safety issue: No ]
  • Effects on other cardiovascular endpoints [ Time Frame: Throughout study, approximately 4.5 years ] [ Designated as safety issue: No ]
  • Glycemic control, lipoprotein profile, blood pressure, biomarkers of cardiovascular risk [ Time Frame: Throughout study, months 1, 3, 6, 9, 12 and then every 6 months thereafter ] [ Designated as safety issue: No ]

Enrollment: 7226
Study Start Date: February 2010
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Aleglitazar
aleglitazar 150 micrograms po daily
Placebo Comparator: 2 Drug: Placebo
placebo control po daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults >18 years of age
  • Type 2 diabetes mellitus
  • Hospitalization for ACS event and randomization between hospital discharge and 8 weeks after the ACS index event (day of hospitalization)

Exclusion Criteria:

  • Estimated glomerular filtration rate <45mL/min/1.73m2
  • Concomitant treatment with a thiazolidinedione and/or fibrate
  • Triglycerides >400 mg/dL
  • Anaemia
  • Symptomatic congestive heart failure classified as NYHA class II-IV (France and Germany: Symptomatic congestive heart failure classified as NYHA class I-IV)
  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: NCT01042769

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States, 35294
Birmingham, Alabama, United States, 35209
Mobile, Alabama, United States, 36617
Mobile, Alabama, United States, 36693
United States, Arizona
Mesa, Arizona, United States, 85206
Phoenix, Arizona, United States, 85023
Phoenix, Arizona, United States, 85029
Tucson, Arizona, United States, 85724-5078
Tucson, Arizona, United States, 85712
United States, California
Anaheim, California, United States, 92801
Banning, California, United States, 92220
Carmichael, California, United States, 95608
Fresno, California, United States, 93720
Fullerton, California, United States, 92835
Glendale, California, United States, 91204
Hawaiian Gardens, California, United States, 90716
Inglewood, California, United States, 90301
Laguna Hills, California, United States, 92653
Long Beach, California, United States, 90822
Los Angeles, California, United States, 90033
Northridge, California, United States, 91325
Orange, California, United States, 92868
Pomona, California, United States, 91767
Redondo Beach, California, United States, 90277
Salinas, California, United States, 93901
San Diego, California, United States, 92103
San Francisco, California, United States, 94115
Santa Ana, California, United States, 92704
Sylmar, California, United States, 91342
Thousand Oaks, California, United States, 91360
Torrance, California, United States, 90502
Ventura, California, United States, 90265
United States, Colorado
Colorado Springs, Colorado, United States, 80909
Denver, Colorado, United States, 80220
Denver, Colorado, United States, 80218
United States, Connecticut
Bridgeport, Connecticut, United States, 06606
Hartford, Connecticut, United States, 06102
Stamford, Connecticut, United States, 06905
United States, Delaware
Seaford, Delaware, United States, 19973
United States, Florida
Aventura, Florida, United States, 33180
Boynton Beach, Florida, United States, 33472
Clearwater, Florida, United States, 33756
Coral Springs, Florida, United States, 33065
Doral, Florida, United States, 33166
Edgewater, Florida, United States, 32141
Elizabeth, Florida, United States, 07202
Ft. Lauderdale, Florida, United States, 33316
Gainesville, Florida, United States, 32608
Hialeah, Florida, United States, 33010
Hollywood, Florida, United States, 33021
Jacksonville Beach, Florida, United States, 32250
Melbourne, Florida, United States, 32901
Miami, Florida, United States, 33136
Miami, Florida, United States, 33173
Miramar, Florida, United States, 33025
Naples, Florida, United States, 34102
Ocala, Florida, United States, 34471
Orlando, Florida, United States, 32806
Panama City, Florida, United States, 32401
Sarasota, Florida, United States, 34239
Sarasota, Florida, United States, 34292
St. Petersburg, Florida, United States, 33709
St. Petersburg, Florida, United States, 33701
Tampa, Florida, United States, 33613
Trinity, Florida, United States, 34652
Vero Beach, Florida, United States, 32960
United States, Georgia
Atlanta, Georgia, United States, 30312
Decatur, Georgia, United States, 30033
Macon, Georgia, United States, 31201
United States, Illinois
Gurnee, Illinois, United States, 60031
United States, Indiana
Elkhart, Indiana, United States, 46514
Indianapolis, Indiana, United States, 46260
Lafayette, Indiana, United States, 47905
United States, Iowa
Ames, Iowa, United States, 50010
Council Bluffs, Iowa, United States, 51501
Davenport, Iowa, United States, 52803
Des Moines, Iowa, United States, 50314
United States, Kentucky
Elizabethtown, Kentucky, United States, 42701
Owensboro, Kentucky, United States, 42303
United States, Louisiana
Alexandria, Louisiana, United States, 71301
Convington, Louisiana, United States, 70433
Hammond, Louisiana, United States, 70403
Houma, Louisiana, United States, 70360
Lafayette, Louisiana, United States, 70508
LaPlace, Louisiana, United States, 70068
Metarie, Louisiana, United States, 70002
New Orleans, Louisiana, United States, 70121
Opelousas, Louisiana, United States, 70570
Shreveport, Louisiana, United States, 71103
Shreveport, Louisiana, United States, 71105
Shreveport, Louisiana, United States, 71101
Slidell, Louisiana, United States, 70458
Zachary, Louisiana, United States, 70791
United States, Maine
Bangor, Maine, United States, 04401
United States, Maryland
Annapolis, Maryland, United States, 21401
Baltimore, Maryland, United States, 21236
Baltimore, Maryland, United States, 21201
Columbia, Maryland, United States, 21044
Oxon Hill, Maryland, United States, 20745
Salisbury, Maryland, United States, 21801
United States, Massachusetts
Boston, Massachusetts, United States, 02215
Boston, Massachusetts, United States, 02114
Fall River, Massachusetts, United States, 02720
Hyannis, Massachusetts, United States, 02601
Worcester, Massachusetts, United States, 01604
United States, Michigan
Alpena, Michigan, United States, 49707
Ann Arbor, Michigan, United States, 48106
Bay City, Michigan, United States, 48708
Flint, Michigan, United States, 48423
Kalamazoo, Michigan, United States, 49048
Lansing, Michigan, United States, 48910
Petoskey, Michigan, United States, 49770
Royal Oak, Michigan, United States, 48073
Saginaw, Michigan, United States, 48602
Saginaw, Michigan, United States, 48604
United States, Minnesota
Minneapolis, Minnesota, United States, 55417
Minneapolis, Minnesota, United States, 55415
Minneapolis, Minnesota, United States, 55407
Rochester, Minnesota, United States, 55905
Saint Paul, Minnesota, United States, 55102
St. Cloud, Minnesota, United States, 56362
United States, Mississippi
Jackson, Mississippi, United States, 39216
Picayune, Mississippi, United States, 39466
United States, Missouri
Chesterfield, Missouri, United States, 63017
Washington, Missouri, United States, 63090
United States, Montana
Great Falls, Montana, United States, 59405
United States, Nebraska
Freemont, Nebraska, United States, 68025
Omaha, Nebraska, United States, 68131
Omaha, Nebraska, United States, 68114
United States, Nevada
Las Vegas, Nevada, United States, 89102
United States, New Jersey
Bridgewater, New Jersey, United States, 08807
Mine Hill, New Jersey, United States, 07803
Newark, New Jersey, United States, 07103
Somerset, New Jersey, United States, 08873
United States, New Mexico
Albuquerque, New Mexico, United States, 87102
Albuquerque, New Mexico, United States, 87131
United States, New York
Albany, New York, United States, 12211
Albany, New York, United States, 12206-1098
Bronx, New York, United States, 10469
Brooklyn, New York, United States, 11215
Buffalo, New York, United States, 14215
New York, New York, United States, 10025
New York, New York, United States, 10032
New York, New York, United States, 10021
New York, New York, United States, 10029
Suffern, New York, United States, 10901
Syracuse, New York, United States, 13210
Troy, New York, United States, 12180
United States, North Carolina
Charlotte, North Carolina, United States, 28204
Durham, North Carolina, United States, 27710
Durham, North Carolina, United States, 27704
Greenville, North Carolina, United States, 27834
Rocky Mount, North Carolina, United States, 27804
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Canton, Ohio, United States, 44708
Cincinnati, Ohio, United States, 45219
Cincinnati, Ohio, United States, 45224
Cleveland, Ohio, United States, 44106
Columbus, Ohio, United States, 43221
Columbus, Ohio, United States, 43201
Dayton, Ohio, United States, 45428
Kettering, Ohio, United States, 45429
Marion, Ohio, United States, 43302
Middleburg Heights, Ohio, United States, 44130
Springfield, Ohio, United States, 45505
Toledo, Ohio, United States, 43608
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73103
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Portland, Oregon, United States, 97239
United States, Pennsylvania
Chambersburg, Pennsylvania, United States, 17201
Danville, Pennsylvania, United States, 17822
Harrisburg, Pennsylvania, United States, 17112
Natrona Heights, Pennsylvania, United States, 15065
Philadelphia, Pennsylvania, United States, 19107
Philadelphia, Pennsylvania, United States, 19106
Philadelphia, Pennsylvania, United States, 19140
Pottstown, Pennsylvania, United States, 19464
Upper Darby, Pennsylvania, United States, 19082
United States, Rhode Island
Pawtucket, Rhode Island, United States, 02860
Providence, Rhode Island, United States, 02906
Providence, Rhode Island, United States, 02903
United States, South Carolina
Greer, South Carolina, United States, 29651
United States, Tennessee
Johnson City, Tennessee, United States, 37604
Kingsport, Tennessee, United States, 37660
Lexington, Tennessee, United States, 38351
Nashville, Tennessee, United States, 37203
Tullahoma, Tennessee, United States, 37388
United States, Texas
Amarillo, Texas, United States, 79106
Austin, Texas, United States, 78705
Bellaire, Texas, United States, 77401
Dallas, Texas, United States, 75230
Dallas, Texas, United States, 75216
Dallas, Texas, United States, 75231
Dallas, Texas, United States, 75390-9063
Grapevine, Texas, United States, 76051
Houston, Texas, United States, 77024
Houston, Texas, United States, 77075
Houston, Texas, United States, 77090
Houston, Texas, United States, 77030
Houston, Texas, United States, 77002
Kerrville, Texas, United States, 78028
Kingwood, Texas, United States, 77339
Lubbock, Texas, United States, 79410
Odessa, Texas, United States, 79761
Plano, Texas, United States, 75024
San Antonio, Texas, United States, 78205
San Antonio, Texas, United States, 78258
San Antonio, Texas, United States, 78229
Tomball, Texas, United States, 77375
Victoria, Texas, United States, 77901
United States, Utah
Layton, Utah, United States, 84041
Murray, Utah, United States, 84157
United States, Virginia
Danville, Virginia, United States, 24541
Roanoke, Virginia, United States, 24104
United States, West Virginia
Huntington, West Virginia, United States, 25701
United States, Wisconsin
Beloit, Wisconsin, United States, 53511
Burlington, Wisconsin, United States, 53105
Green Bay, Wisconsin, United States, 54301
LaCrosse, Wisconsin, United States, 54601-4795
Milwaukee, Wisconsin, United States, 53295
Milwaukee, Wisconsin, United States, 53215
Argentina
Buenos Aires, Argentina, C1425AGC
Buenos Aires, Argentina, C1426AGU
Buenos Aires, Argentina, C1437BZL
Buenos Aires, Argentina, 1428
Buenos Aires, Argentina, 1425DES
Buenos Aires, Argentina, c1181ach
Buenos Aires, Argentina, C1155ADP
Caba, Argentina, C1405BCK
Caba, Argentina, C1119ACN
Caba, Argentina, C1428DCO
Capital Federal, Argentina, 1180
Ciudad Autonoma Bs As, Argentina, C1280AEB
Cordoba, Argentina, 5009
Cordoba, Argentina, 5000
Cordoba, Argentina, X5000EPU
Coronel Suarez, Argentina, B7540GDH
Corrientes, Argentina, W3400AMZ
Haedo, Argentina, B1706AJU
Mendoza, Argentina, 5500
Moron, Argentina, 1708
Rosario, Argentina, 2000
Rosario, Argentina, S2002OUR
Rosario, Argentina, S2000DIF
Salta, Argentina, 4400
Santa Fe, Argentina, 3000
Santiago del Estero, Argentina, G4200AQK
Tucuman, Argentina, 4000
Zarate, Argentina, 2800
Australia, Australian Capital Territory
Woden, Australian Capital Territory, Australia, 2606
Australia, New South Wales
Bankstown, New South Wales, Australia, 2200
Concord, New South Wales, Australia, 2139
Darlinghurst, New South Wales, Australia, 2010
Liverpool BC, New South Wales, Australia, 1871
New Lambton, New South Wales, Australia, 2305
Penrith, New South Wales, Australia, 2751
St. Leonards, New South Wales, Australia, 2065
Sydney, New South Wales, Australia, 2217
Wollongong, New South Wales, Australia, 2500
Australia, Queensland
Douglas, Queensland, Australia, 4184
Milton, Queensland, Australia, 4064
Redcliffe, Queensland, Australia, 4020
Southport, Queensland, Australia, 4215
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Adelaide, South Australia, Australia, 5000
Elizabeth Vale, South Australia, Australia, 5112
Woodville, South Australia, Australia, 5011
Australia, Victoria
Ballarat, Victoria, Australia, 3353
Geelong, Victoria, Australia, 3220
Richmond, Victoria, Australia, 3121
Shepparton, Victoria, Australia, 3630
Brazil
Salvador, BA, Brazil, 40010020
Fortaleza, CE, Brazil, 60430-370
Fortaleza, CE, Brazil, 60430970
Fortaleza, CE, Brazil, 60115282
Fortaleza, CE, Brazil, 60840285
Brasilia, DF, Brazil, 71625-009
Cariacica, ES, Brazil, 29151920
Goiania, GO, Brazil, 74823-470
Belo Horizonte, MG, Brazil, 30150-240
Belo Horizonte, MG, Brazil, 30150-221
Belo Horizonte, MG, Brazil, 30110-068
Uberlandia, MG, Brazil, 38400-368
Campo grande, MS, Brazil, 79070900
Recife, PE, Brazil, 50100-060
Campina Grande do Sul, PR, Brazil, 83430-000
Curitiba, PR, Brazil, 80730-150
Curitiba, PR, Brazil, 80320-320
Curitiba, PR, Brazil, 80220-000
Rio de Janeiro, RJ, Brazil, 22240-006
Rio de Janeiro, RJ, Brazil, 22271-100
Natal, RN, Brazil, 59020-100
Passo Fundo, RS, Brazil, 99010-080
Porto Alegre, RS, Brazil, 90110-270
Porto Alegre, RS, Brazil, 91350-200
Porto Alegre, RS, Brazil, 90020-090
Porto Alegre, RS, Brazil, 90610-000
Porto Alegre, RS, Brazil, 90035-170
Porto Alegre, RS, Brazil, 90035-003
Porto Alegre, RS, Brazil, 90620-001
Sao Jose, SC, Brazil, 88103-460
Sao Jose do Rio Preto, SC, Brazil, 15015-210
Campinas, SP, Brazil, 13024-011
Campinas, SP, Brazil, 13060-803
Sao Jose do Rio Preto, SP, Brazil, 15090-000
Sao Paulo, SP, Brazil, 01244-030
Sao Paulo, SP, Brazil, 1506000
Sao Paulo, SP, Brazil, 05403-000
Canada, Alberta
Edmonton, Alberta, Canada, T6K 4C1
Edmonton, Alberta, Canada, T5H 3V9
Edmonton, Alberta, Canada, T6L5X8
Red Deer, Alberta, Canada, T4N 6R2
Canada, British Columbia
New Westminster, British Columbia, Canada, V3L 3W4
Surrey, British Columbia, Canada, V3V 1Z2
Canada, New Brunswick
Bathurst, New Brunswick, Canada, E2A 1A9
Moncton, New Brunswick, Canada, E1L 2Z3
Moncton, New Brunswick, Canada, E1G 1A7
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Newfoundland and Labrador
St Johns, Newfoundland and Labrador, Canada, A1E2C2
Canada, Nova Scotia
Bridgewater, Nova Scotia, Canada, B4V 3N2
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Brampton, Ontario, Canada, L6Z 4N5
Brampton, Ontario, Canada, L6W2X7
Burlington, Ontario, Canada, L7R4EZ
Burlington, Ontario, Canada, L7M 4Y1
Cambridge, Ontario, Canada, N1R 6V6
Cambridge, Ontario, Canada, N1R 7R1
Fort Eire, Ontario, Canada, L2A1Z3
Hamilton, Ontario, Canada, L8L 2X2
Kingston, Ontario, Canada, K7L 5G2
Kitchener, Ontario, Canada, N2M 1B2
London, Ontario, Canada, N6C 5J1
MIssissauga, Ontario, Canada, L5B 2P7
Mississauga, Ontario, Canada, L4T2J2
NewMarket, Ontario, Canada, L3Y 8C3
Oshawa, Ontario, Canada, L1H 1B9
Smiths Falls, Ontario, Canada, K7A 4W8
Sudbury, Ontario, Canada, P3E 5J1
Sudbury, Ontario, Canada, P3E 3B8
Sudbury, Ontario, Canada, P3C 5K7
Thunder Bay, Ontario, Canada, P7B 6V4
Toronto, Ontario, Canada, M5B 1W8
Canada, Prince Edward Island
Charlottetown, Prince Edward Island, Canada, C1A 8T5
Canada, Quebec
Chicoutimi, Quebec, Canada, G7H 5H6
Chicoutimi, Quebec, Canada, G7H 7Y8
Gatineau, Quebec, Canada, J8Y 6S9
Granby, Quebec, Canada, J2G 8Z9
Granby, Quebec, Canada, J2G 1T7
Laval, Quebec, Canada, H7M 3L9
Longueuil, Quebec, Canada, J4M 2X1
Lévis, Quebec, Canada, G6V 4Z5
Montreal, Quebec, Canada, H3G 1A4
Montreal, Quebec, Canada, H4J 1C5
Montreal, Quebec, Canada, H1T 1C8
Montréal, Quebec, Canada, H2K 4L5
Quebec city, Quebec, Canada, G1G 3Z4
Quebec city, Quebec, Canada, G1N 4V3
Saint-Laurent, Quebec, Canada, H4T 1Z9
Sherbrooke, Quebec, Canada, J1J 2E3
Sherbrooke, Quebec, Canada, J1H 5N4
St-Charles-Borromée, Quebec, Canada, J6E 6J2
St-jerome, Quebec, Canada, J7Z 5T3
St-Lambert, Quebec, Canada, J4P 2H4
St-Léonard, Quebec, Canada, H1S 3A9
Ste. Foy, Quebec, Canada, G1V 4G5
Terrebonne, Quebec, Canada, J6V 2H2
Trois-Rivieres, Quebec, Canada, G8Z 3R9
Val DOr, Quebec, Canada, J9P 3Y1
Vaudreuil-Dorion, Quebec, Canada, J7V 8P9
China
Baotou, China, 014040
Beijing, China, 100020
Beijing, China, 100853
Beijing, China, 100029
Beijing, China, 100730
Beijing, China, 100050
Beijing, China, 100101
Beijing, China, 100088
Beijing, China, 100038
Beijng, China, 100700
Changsha, China, 410007
Changsha, China, 410013
Changsha, China, 410011
Chengdu, China, 610041
Dalian, China, 116011
Daqing City, China, 163001
Guangzhou, China, 510030
Guangzhou, China, 510080
Hangzhou, China, 310003
Hangzhou, China, 310013
Hangzhou, China, 310016
Jinan, China, 250012
Jingan District, China, 200040
Nanjing, China, 210009
Nanning, China, 530021
Qingdao, China, 266011
Shanghai, China, 200233
Shanghai, China, 200031
Shanghai, China, 200030
Shanghai, China, 200011
Shanghai, China, 200072
Shanghai, China, 200127
Shanghai, China, 200065
Shen Yang, China, 110004
Shenyang, China, 110016
Shenyang, China, 110015
Shijiazhuang, China, 050082
Tianjin, China, 300014
Wuhan, China, 430071
Xi'an, China, 710061
Czech Republic
Brno, Czech Republic, CA-656 91
Brno, Czech Republic, 625 00
Hradec Kralove, Czech Republic, 50005
Jindrichuv Hradec, Czech Republic, 37701
Kladno, Czech Republic, 27259
Olomouc, Czech Republic, 77520
Prague, Czech Republic, 14021
Prague 2, Czech Republic, 128 08
Prague 2, Czech Republic, 128 00
Tabor, Czech Republic, 390 03
Teplice, Czech Republic, 41529
Trutnov, Czech Republic, 541 01
Znojmo, Czech Republic, 669 02
Denmark
Aalborg, Denmark, 9000
Copenhagen, Denmark
Fredericia, Denmark, 7000
Herning, Denmark, 7400
Odense, Denmark, 5000 C
Slagelse, Denmark, 4200
France
Albi, France, 81000
Besancon, France, 25000
Bron, France, 69677
Cambrai, France, 59407
Creteil, France, 94010
Dijon, France, 21079
Lagny-sur-marne, France, 77405
Le Coudray, France, 28630
Le Plessis Robinson, France, 92350
Marseille, France, 13285
Montfermeil, France, 93370
Montpellier, France, 34295
Paris, France, 75651
Paris, France, 75908
Pessac, France, 3600
St Herblain, France, 44800
Valenciennes, France, 59322
Germany
Bad Krozingen, Germany, 79189
Bad Nauheim, Germany, 61231
Bad Oeynhausen, Germany, 32545
Bad Rothenfelde, Germany, 49124
Berlin, Germany, 12559
Berlin, Germany, 12203
Berlin, Germany, 13187
Berlin, Germany, 14050
Berlin, Germany, 13353
Bernried, Germany, 82347
Bochum, Germany, 44789
Bonn, Germany, 53127
Brandenburg, Germany, 14770
Burg, Germany, 03096
Cologne, Germany, 50923
Dortmund, Germany, 44137
Düsseldorf, Germany, 40225
Essen, Germany, 45122
Frankfurt, Germany, 65929
Fulda, Germany, 36043
Fürth, Germany, 90766
Halle, Germany, 06120
Hamburg, Germany, 20099
Hannover, Germany, 30167
Heidelberg, Germany, 69126
Homburg/Saar, Germany, 66424
Kiel, Germany, 24105
Lahr, Germany, 77933
Langen, Germany, 63225
Mainz, Germany, 55131
Mannheim, Germany, 68167
Muenchen, Germany, 80336
Münchengladbach, Germany, 41063
Münster, Germany, 48149
Nienburg, Germany, 31582
Pirna, Germany, 01796
Regensburg, Germany, 93053
Rotenburg, Germany, 36199
Ruedersdorf, Germany, 15562
Wuppertal, Germany, 42117
Grenada
Toulouse, Grenada, 31059
Hungary
Balatonfuered, Hungary, 8230
Budapest, Hungary, 1085
Budapest, Hungary, 1032
Budapest, Hungary, 1115
Budapest, Hungary, 1088
Budapest, Hungary, 1096
Budapest, Hungary, 1196
Debrecen, Hungary, 4032
Gyula, Hungary, 5700
Kaposvár, Hungary, 7400
Kecskemet, Hungary, 6000
Miskolc, Hungary, 3526
Pécs, Hungary, 7643
Szolnok, Hungary, 5004
Szombathely, Hungary, 9700
Székeshehérvár, Hungary, 8000
Zalaegerszeg, Hungary, 8900
India
Ahmedabad, India, 380015
Ahmedabad, India, 380014
Ahmedabad, India, 380051
Ahmedabad, India, 380005
Bangalore, India, 560060
Bangalore, India, 560099
Bangalore, India, 560038
Banglore, India, 560034
Belgaum, India, 590001
Belgaum, India, 590010
Chennai, India, 600100
Cochin, India, 682041
Gurgaon, India, 122001
Hyderabad, India, 500001
Hyderabad, India, 500024
Hyderabad, India, 500063
Hyderabad, India, 500034
Hyderabad, India, 500004
Indore, India, 452001
Jaipur, India, 302004
Kochi, India, 682304
Kolkata, India, 700020
Lucknow, India, 226014
Madhurai, India, 625107
Mangalore, India, 575001
Mangalore, India, 575 002
Mangalore, India, 575002
Mumbai, India, 400012
Mumbai, India, 400051
Mysore, India, 570004
Nagpur, India, 440008
Nagpur, India, 440010
New Delhi, India, 110060
Palakkad, India, 678013
Pune, India, 411030
Pune, India, 411011
Pune, India, 411004
Pune, India, 411 001
Secunderabad, India, 500003
Trivandeum, India, 695011
Ireland
Ballinasloe, Ireland
Dublin, Ireland, 9
Dublin, Ireland, 7
Dublin, Ireland, 8
Galway, Ireland
Tallaght Dublin, Ireland, D24
Italy
Napoli, Campania, Italy, 80131
Pozzuoli, Campania, Italy, 80078
Bentivoglio, Emilia-Romagna, Italy, 40010
Ferrara, Emilia-Romagna, Italy, 44100
Reggio Emilia, Emilia-Romagna, Italy, 42123
Udine, Friuli-Venezia Giulia, Italy, 33100
Rome, Lazio, Italy, 00189
Bergamo, Lombardia, Italy, 24128
Legnano, Lombardia, Italy, 20025
Mantova, Lombardia, Italy, 46100
Milano, Lombardia, Italy, 20162
Milano, Lombardia, Italy, 20138
Pavia, Lombardia, Italy, 27100
Perugia, Umbria, Italy, 06100
Cittadella, Veneto, Italy, 35013
Rovigo, Veneto, Italy, 45100
Korea, Republic of
Busan, Korea, Republic of, 602-702
Busan, Korea, Republic of, 614-735
Busan, Korea, Republic of, 602-739
Daegu, Korea, Republic of, 700-712
Daegu, Korea, Republic of, 705-717
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, 420-818
Gyeonggi-do, Korea, Republic of, 443-380
Incheon, Korea, Republic of, 405-760
Incheon, Korea, Republic of, 400-711
Jeollabuk-do, Korea, Republic of, 561-712
Kyonggi-do, Korea, Republic of, 411-719
Seoul, Korea, Republic of, 152-703
Seoul, Korea, Republic of, 136-705
Seoul, Korea, Republic of, 130-702
Seoul, Korea, Republic of, 110744
Seoul, Korea, Republic of, 140-743
Seoul, Korea, Republic of, 156-755
Seoul, Korea, Republic of, 156-707
Seoul, Korea, Republic of, 150-950
Suwon, Korea, Republic of, 442-723
Uijongbu, Korea, Republic of, 480-130
Ulsan, Korea, Republic of, 682-714
Wonju, Korea, Republic of, 220-701
Malaysia
Kelantan, Malaysia, 16150
Kota Bharu, Malaysia, 15586
Kuala Lumpur, Malaysia, 59100
Kuala Lumpur, Malaysia, 50400
Kuantan, Malaysia, 25100
Penang, Malaysia, 10990
Sarawak, Malaysia, 93586
Serdang, Malaysia, 43000
Mexico
Acapulco, Mexico, 39670
Aguascalientes, Mexico, 20127
Aguascalientes, Mexico, 20230
Chihuahua, Mexico, 31000
Chihuahua, Mexico, 31217
Ciudad Juárez, Mexico, 32420
Cuernavaca, Mexico, 62250
Culiacan, Mexico, 80020
Durango, Mexico, 34000
Durango, Mexico, 34080
Guadalajara, Mexico, 44650
Guadalajara, Mexico, 44600
Guadalajara, Mexico, 44210
Mexico City, Mexico, 14080
Mexico City, Mexico, 11650
Mexico City, Mexico, 10700
Mexico City, Mexico, 14000
Mexico City, Mexico, 14050
Monterrey, Mexico, 64060
Monterrey, Mexico, 64640
Monterrey, Mexico, 64710
Monterrey, Mexico, 64460
Pachuca, Mexico, 42000
Puebla, Mexico, 72490
Puerto Vallarta, Mexico, 48328
Queretaro, Mexico, 76000
San Luis Potosi S.L.P., Mexico, 78240
Tampico, Mexico, 89000
Tijuana, Mexico, 22010
Tlalnepantla, Mexico, 54055
Veracruz, Mexico, 91700
Xalapa, Mexico, 91020
Zapopan, Mexico, 45200
Netherlands
AC Amsterdam, Netherlands, 1091
Amstelveen, Netherlands, 1186 AH
Amsterdam, Netherlands, 1066 EC
Amsterdam, Netherlands, 1105 AZ
Hoorn, Netherlands, 1625 HV
Leiden, Netherlands, 2333 ZA
Maastricht, Netherlands, 6202 AZ
Nieuwegein, Netherlands, 3435 CM
Nijmegen, Netherlands, 6500 HB
Purmerend, Netherlands, 1441 RN
Tilburg, Netherlands, 5042 AD
Weert, Netherlands, 6001 BE
Zaandam, Netherlands, 1502 DV
Zwolle, Netherlands, 8011 JW
New Zealand
Auckland, New Zealand
Christchurch, New Zealand, 8140
Hamiton, New Zealand, 3240
Lower Hutt, New Zealand, 5040
Nelson, New Zealand, 7001
Palmerston North, New Zealand, 4410
Tauranga, New Zealand, 3112
Poland
Bialystok, Poland, 15-276
Bielsko-Biala, Poland, 43-316
Bydgoszcz, Poland, 85-863
Bydgoszcz, Poland, 85-826
Bytom, Poland, 41-902
Bêdzin, Poland, 42-500
Cracow, Poland, 30-092
Gdansk, Poland, 80-952
Gdansk, Poland, 80-126
Gdynia, Poland, 81-423
Gdynia, Poland, 81-472
Gdynia, Poland, 81-519
Gdynia, Poland, 81-402
Gorlice, Poland, 38-300
Grodzisk Mazowiecki, Poland, 05-754
Katowice, Poland, 40-005
Kedzierzyn-Kozle, Poland, 47-200
Kielce, Poland, 25-315
Krakow, Poland, 30-082
Krakow, Poland, 31-351
Krakow, Poland, 31-202
Kutno, Poland, 99-300
Libiaz, Poland, 32-590
Lodz, Poland, 91-490
Lodz, Poland, 91-302
Lublin, Poland, 20-834
Lublin, Poland, 20-059
Nowa Sol, Poland, 67-100
Nysa, Poland, 48-303
Olawa, Poland, 55-200
Olesnica, Spalice, Poland, 56-400
Olsztyn, Poland, 10-561
Poznan, Poland, 61-848
Pulawy, Poland, 24-100
Radom, Poland, 26-600
Rzeszow, Poland, 35301
Swidnica, Poland, 58-100
Tarnow, Poland, 33-100
Tarnów, Poland, 33-100
Torun, Poland, 87-100
Ustron, Poland, 43-450
Ustroñ, Poland, 43-450
Warsaw, Poland, 02-637
Warsaw, Poland, 02-097
Warszawa, Poland, 04-141
Warszawa, Poland, 02-097
Warszawa, Poland, 03-242
Warszawa, Poland, 03-599
Wola, Poland, 43-225
Wroclaw, Poland, 50-981
Zamosc, Poland, 22-400
Zarow, Poland, 58-130
Zgorzelec, Poland, 59-900
£ódx, Poland, 91-347
Romania
Brasov, Romania, 500360
Bucharest, Romania, 010628
Bucharest, Romania, 020992
Buzau, Romania, 120203
Cluj-Napoca, Romania, 400006
Craiova, Romania, 200147
Galati, Romania, 800371
Oradea, Romania, 410169
Ploiesti, Romania, 100163
Targu-Mures, Romania, 540124
Timisoara, Romania, 300310
Russian Federation
Moscow, Russian Federation, 111539
Saint-Petersburg, Russian Federation, 194291
Saint-Petersburg, Russian Federation, 197341
Saint-Petersburg, Russian Federation, 193312
Spain
Vitoria, Alava, Spain, 01009
Torrevieja, Alicante, Spain, 03186
Oviedo, Asturias, Spain, 33006
Granollers, Barcelona, Spain, 08400
Hospitalet de Llobregat, Barcelona, Spain, 08907
Sabadell, Barcelona, Spain, 08208
Terrassa, Barcelona, Spain, 08227
Jerez de La Frontera, Cadiz, Spain, 11402
Figueres, Girona, Spain, 17600
Coruna, La Coruña, Spain, 15006
Ferrol, La Coruña, Spain, 15405
Santiago de Compostela, La Coruña, Spain, 15706
Alcorcon, Madrid, Spain, 28922
San Sebastian de los Reyes, Madrid, Spain, 28702
Seville, Sevilla, Spain, 41071
Reus, Tarragona, Spain, 43201
Bilbao, Vizcaya, Spain, 48013
Alicante, Spain, 03010
Almeria, Spain, 04009
Barcelona, Spain, 08025
Barcelona, Spain, 08035
Barcelona, Spain, 08003
Guadalajara, Spain, 19002
Lugo, Spain, 27004
Madrid, Spain, 28041
Madrid, Spain, 28007
Madrid, Spain, 28040
Malaga, Spain, 29010
Murcia, Spain, 30008
Salamanca, Spain, 37007
Tarragona, Spain, 43007
Valencia, Spain, 46017
Valencia, Spain, 46014
Sweden
Danderyd Stockholm, Sweden, SE-182 88
Goteborg, Sweden, 413 45
Halmstad, Sweden, 301 85
Kalmar, Sweden, 391 85
Karlstad, Sweden, 65185
Kristianstad, Sweden, 29185
Malmö, Sweden, 20502
Ostersund, Sweden, 83 183
Skellefteå, Sweden, 0910-77
Skovde, Sweden, 541 85
Stockholm, Sweden, 17176
Stockholm, Sweden, 11883
Thailand
Amphur Mae-Rim, Thailand, 50180
Amphur Muang, Thailand, 65000
Amphur Muang, Thailand, 57000
Bangkok, Thailand, 10700
Bangkok, Thailand, 10330
Bangkok, Thailand, 10400
Bangkok, Thailand, 10300
ChiangMai, Thailand, 50200
Chonburi, Thailand, 20000
Khon Kaen, Thailand, 40002
Khonkaen, Thailand, 40000
Klong Luang, Thailand, 12120
Phitsanulok, Thailand, 65000
Saraburi, Thailand, 18000
United Kingdom
Abano Terme, United Kingdom, 35031
Antrim, United Kingdom, BT41 2RL
AYR, United Kingdom, KA6 6DX
Basildon, United Kingdom, SS16 5NL
Bath, United Kingdom, BA1 3NG
Belfast, United Kingdom, BT13 3BW
Belfast, United Kingdom, BT47 6SB
Brighton, United Kingdom, BN2 1ES
Cambridge, United Kingdom, CB2 0QQ
Craigavon, United Kingdom, BT63 5QQ
Derby, United Kingdom, DE22 3DT
Glasgow, United Kingdom, G11 6NK
Harrow, United Kingdom, HA1 3UJ
Inverness, United Kingdom, IV2 4RE
Isle of Wight, United Kingdom, 30 5TG.
Isleworth, United Kingdom, TW7 6AF
Leeds, United Kingdom
London, United Kingdom, N6A 4L6
London, United Kingdom, E1 2AT
Manchester, United Kingdom, M13 9WL
Middlesex, United Kingdom, UB1 3HW
Newcastle upon Tyne, United Kingdom, NE7 7DN
Northampton, United Kingdom, NN1 5BD
Paddington, United Kingdom, W2 1LA
Plymouth, United Kingdom, PL6 8BX
Poole, United Kingdom, BH15 2JB
Romford, United Kingdom, RM7 0AG
Stoker on Trent, United Kingdom, ST4 6QG
West Bromwich, United Kingdom, B71 4HJ
Wrexham, United Kingdom, LL137TD
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01042769     History of Changes
Other Study ID Numbers: BC22140, 2009-012269-71
Study First Received: January 5, 2010
Last Updated: September 22, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Acute Coronary Syndrome
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 01, 2014