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

November 1, 2016 updated by: Hoffmann-La Roche

A PHASE 3B STUDY TO EVALUATE THE POTENTIAL OF ALEGLITAZAR TO REDUCE CARDIOVASCULAR RISK IN PATIENTS WITH STABLE CARDIOVASCULAR DISEASE AND GLUCOSE ABNORMALITIES

This randomized, double-blind, placebo-controlled, parallel group, multicenter study 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 matching placebo.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1999

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Caba, Argentina, C1119ACN
      • Caba, Argentina, C1428DCO
  • 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
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
    • South Australia
      • Adelaide, South Australia, Australia, 5000
      • Woodville, South Australia, Australia, 5011
    • Tasmania
      • Launceston, Tasmania, Australia, 7250
    • Victoria
      • Geelong, Victoria, Australia, 3220
      • Heidelberg, Victoria, Australia, 3081
      • Melbourne, Victoria, Australia, 3004
    • 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
      • Quebec, Canada, G3K 2P8
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 1E4
      • Surrey, British Columbia, Canada, V3V 1Z2
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3P4
    • New Brunswick
      • Bathurst, New Brunswick, Canada, E2A 4X7
    • 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
    • Prince Edward Island
      • Quebec, Prince Edward Island, Canada, G1V 4G2
    • 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 1C8
      • Montreal, Quebec, Canada, H3G 1A4
      • Montreal, Quebec, Canada, H1T 3Y7
      • 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
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 3H3
  • Chile
      • Las Condes, Chile, 7500710
      • Santiago, Chile, 7500710
      • Santiago, Chile, 7500010
      • Santiago, Chile, 7500347
      • Temuco, Chile, 4781156
      • Temuco, Chile, 4790869
      • Temuco, Chile, 4813299
  • 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, 625 00
      • Brno, Czech Republic, 601 77
      • 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, 150 06
      • Praha 5, Czech Republic, 158 00
      • 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-Charlottenburg, Germany, 14050
      • Bochum, Germany, 44787
      • Chemnitz, Germany, 09111
      • Damme, Germany, 49401
      • Dresden, Germany, 01067
      • Frankfurt, Germany, 65929
      • Frankfurt, Germany, 60596
      • Hannover, Germany, 30159
      • Homburg/Saar, 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, 1125
      • Budapest, Hungary, 1085
      • Budapest, Hungary, 1036
      • Budapest, Hungary, 1097
      • Budapest, Hungary, 1027
      • Budapest, Hungary, 1023
      • 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
    • Campania
      • Naples, Campania, Italy, 80122
      • Napoli, Campania, Italy, 80131
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40133
    • Lazio
      • Roma, Lazio, Italy, 00128
      • Rome, Lazio, Italy, 00185
    • Lombardia
      • Milano, Lombardia, Italy, 20132
      • Milano, Lombardia, Italy, 20138
      • Pavia, Lombardia, Italy, 27100
    • Marche
      • Pesaro, Marche, Italy, 61121
    • Sicilia
      • Catania, Sicilia, Italy, 95122
      • Palermo, Sicilia, Italy, 90127
    • Toscana
      • Massa, Toscana, Italy, 54100
  • Japan
      • Tochigi, Japan, 329-0498
  • Korea, Republic of
      • Busan, Korea, Republic of, 602-739
      • Busan, Korea, Republic of, 602-715
      • Daejeon, Korea, Republic of, 35015
      • Gwangju, Korea, Republic of, 61469
      • Gyeonggi-Do, Korea, Republic of, 431-070
      • Gyeonggi-do, Korea, Republic of, 443-380
      • Gyeonggi-do, Korea, Republic of, 10380
      • Gyeonggi-do, Korea, Republic of, 11765
      • Gyeonggi-do, Korea, Republic of, 410-773
      • Incheon, Korea, Republic of, 405-760
      • Seoul, Korea, Republic of, 137-701
      • Seoul, Korea, Republic of, 130-872
      • Seoul, Korea, Republic of, 156-707
      • Seoul, Korea, Republic of, 05030
      • Seoul, Korea, Republic of, 06273
      • Suwon-si,, Korea, Republic of, 442-723
      • Wonju, Korea, Republic of, 220-701
  • Latvia
      • Liepaja, Latvia, 3400
      • Riga, Latvia, LV-1002
      • Riga, Latvia, LV-1012
      • Riga, Latvia, LV-1024
      • Riga, Latvia, LV-1058
  • Lithuania
      • Kaunas, Lithuania, 48259
      • Kaunas, Lithuania, 50184
      • Kaunas, Lithuania, LT-47144
      • 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, 40-748
      • Katowice, Poland, 40-954
      • Krakow, Poland, 31-202
      • Krakow, Poland, 31-261
      • Krakow, Poland, 30-015
      • Krakow, Poland, 30-082
      • Lodz, Poland, 90-242
      • Lublin, Poland, 20-044
      • Lublin, Poland, 20-093
      • 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, 050098
      • Bucuresti, Romania, 020359
      • 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
      • Albacete, Spain, 02006
      • Almeria, Spain, 04009
      • Barcelona, Spain, 08036
      • Barcelona, Spain
      • Barcelona, Spain, 08003
      • 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
    • Alicante
      • San Juan de Alicante, Alicante, Spain, 3550
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spain, 08907
    • Islas Baleares
      • Palma de Mallorca, Islas Baleares, Spain, 07014
    • La Coruña
      • Santiago de Compostela, La Coruña, Spain, 15706
    • Lerida
      • Lleida, Lerida, Spain, 25198
    • Malaga
      • Málaga, Malaga, Spain, 29009
    • Sevilla
      • Seville, Sevilla, Spain, 41009
    • Valencia
      • Alzira, Valencia, Spain, 46600
  • Sweden
      • Malmö, Sweden, 205 02
      • Stockholm, Sweden, 171 76
      • Stockholm, Sweden, 111 35
      • Stockholm, Sweden, 113 61
  • 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, G20 0SP
      • Glasgow, United Kingdom, G12 8QQ
      • Inverness, United Kingdom, IV2 4AG
      • Liverpool, United Kingdom, L9 7AL
      • Liverpool, United Kingdom, L22 0LG
      • Manchester, United Kingdom, M15 6SX
      • Mortimer, United Kingdom, RG7 3SQ
      • Reading, United Kingdom, RG2 0TG
      • Soham, Ely, United Kingdom, CB7 5JD
  • United States
    • Alabama
      • Muscle Shoals, Alabama, United States, 35662
    • Arizona
      • Gilbert, Arizona, United States, 85295
      • Phoenix, Arizona, United States, 85018
      • Tucson, Arizona, United States, 85724
    • 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, 90036
      • Los Angeles, California, United States, 90017
      • Los Angeles, California, United States, 90057
      • 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
    • Colorado
      • Denver, Colorado, United States, 80209
    • Florida
      • Atlantis, Florida, United States, 33462
      • Bradenton, Florida, United States, 34208
      • Brooksville, Florida, United States, 34601
      • Clearwater, Florida, United States, 33756
      • Clearwater, Florida, United States, 33755
      • 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
    • Georgia
      • Augusta, Georgia, United States, 30909
      • Decatur, Georgia, United States, 30030
      • Dunwoody, Georgia, United States, 30338
    • Idaho
      • Eagle, Idaho, United States, 83616
      • Idaho Falls, Idaho, United States, 83404
    • Illinois
      • Melrose Park, Illinois, United States, 60160
    • Indiana
      • Brownsburg, Indiana, United States, 46112
      • Evansville, Indiana, United States, 47714
      • Valparaiso, Indiana, United States, 46383
    • Iowa
      • Council Bluffs, Iowa, United States, 51501
      • Iowa City, Iowa, United States, 52242
    • Kansas
      • Wichita, Kansas, United States, 67203
    • Kentucky
      • Lexington, Kentucky, United States, 40504
      • Louisville, Kentucky, United States, 40213
      • Owensboro, Kentucky, United States, 42303
    • Louisiana
      • Alexandria, Louisiana, United States, 71301
    • Maine
      • Bangor, Maine, United States, 04401
    • Maryland
      • Baltimore, Maryland, United States, 21215
      • Baltimore, Maryland, United States, 21201
      • Baltimore, Maryland, United States, 21209
      • Oxon Hill, Maryland, United States, 20745
    • Massachusetts
      • Haverhill, Massachusetts, United States, 01830
    • Michigan
      • Traverse City, Michigan, United States, 49684
    • Mississippi
      • Fall Rivers, Mississippi, United States, 02720
    • Missouri
      • Kansas City, Missouri, United States, 64111
    • Nebraska
      • Bellevue, Nebraska, United States, 68005
      • Fremont, Nebraska, United States, 68025
    • Nevada
      • Las Vegas, Nevada, United States, 89106
      • Las Vegas, Nevada, United States, 89121
      • Las Vegas, Nevada, United States, 89123
    • New Jersey
      • Elizabeth, New Jersey, United States, 07202
    • 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
    • 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
    • North Dakota
      • Fargo, North Dakota, United States, 58103
    • Ohio
      • Akron, Ohio, United States, 44313
      • Gallipolis, Ohio, United States, 45631
      • Kettering, Ohio, United States, 45429
      • Zanesville, Ohio, United States, 43701
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
      • Tulsa, Oklahoma, United States, 74104
    • Oregon
      • Portland, Oregon, United States, 97220
    • 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
    • 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
    • South Dakota
      • Dakota Dunes, South Dakota, United States, 57049
    • 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
    • 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, 77074
      • Houston, Texas, United States, 77036
      • 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, 78229
      • San Antonio, Texas, United States, 78224
      • Tyler, Texas, United States, 75701
    • Utah
      • Bountiful, Utah, United States, 84010
      • Draper, Utah, United States, 84020
      • Murray, Utah, United States, 84123
      • Salt Lake City, Utah, United States, 84124
    • Virginia
      • Burke, Virginia, United States, 22015
      • Manassas, Virginia, United States, 20110
      • Suffolk, Virginia, United States, 23435
    • Washington
      • Port Orchard, Washington, United States, 98366
      • Spokane, Washington, United States, 99207
    • Wisconsin
      • Madison, Wisconsin, United States, 53719

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

36 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
matching aleglitazar placebo tablet orally daily
Experimental: Aleglitazar
Drug: aleglitazar
150 mcg orally daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
5 years
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
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 25, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 29, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BC28027
  • 2012-000671-16 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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