AzTrials
AzTrials

Diabetes Mellitus Type 2Phase 3NCT01042769

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

A Phase 3 study testing Aleglitazar in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 810 sites in 27 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This double-blind, parallel, two-arm study will evaluate the potential to reduce cardiovascular risk, the tolerability and long-term safety profile of aleglitazar compared to placebo on top of standard care in patients with recent acute coronary syndrome (ACS) and type 2 diabetes mellitus. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus Type 2
What is being tested?
Aleglitazar
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
7,226 participants
Where
810 sitesin 27 countries
Study dates
Feb 2010to Nov 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

810 sites in 27 countries.

810 sites in 27 countries

United States221 sites
  • Study site

    Albany, New York, 12206-1098

  • Study site

    Albany, New York, 12211

  • Study site

    Albuquerque, New Mexico, 87102

  • Study site

    Albuquerque, New Mexico, 87131

  • Study site

    Alexandria, Louisiana, 71301

  • Study site

    Alpena, Michigan, 49707

  • Study site

    Amarillo, Texas, 79106

  • Study site

    Ames, Iowa, 50010

  • Study site

    Anaheim, California, 92801

  • Study site

    Ann Arbor, Michigan, 48106

  • Study site

    Annapolis, Maryland, 21401

  • Study site

    Atlanta, Georgia, 30312

  • Study site

    Austin, Texas, 78705

  • Study site

    Aventura, Florida, 33180

  • Study site

    Baltimore, Maryland, 21201

  • Study site

    Baltimore, Maryland, 21236

  • Study site

    Bangor, Maine, 04401

  • Study site

    Banning, California, 92220

  • Study site

    Bay City, Michigan, 48708

  • Study site

    Bellaire, Texas, 77401

  • Study site

    Beloit, Wisconsin, 53511

  • Study site

    Birmingham, Alabama, 35209

  • Study site

    Birmingham, Alabama, 35294

  • Study site

    Boston, Massachusetts, 02114

  • Study site

    Boston, Massachusetts, 02215

  • Study site

    Boynton Beach, Florida, 33472

  • Study site

    Bridgeport, Connecticut, 06606

  • Study site

    Bridgewater, New Jersey, 08807

  • Study site

    Brooklyn, New York, 11215

  • Study site

    Buffalo, New York, 14215

  • Study site

    Burlington, Wisconsin, 53105

  • Study site

    Canton, Ohio, 44708

  • Study site

    Carmichael, California, 95608

  • Study site

    Chambersburg, Pennsylvania, 17201

  • Study site

    Charlotte, North Carolina, 28204

  • Study site

    Chesterfield, Missouri, 63017

  • Study site

    Cincinnati, Ohio, 45219

  • Study site

    Cincinnati, Ohio, 45224

  • Study site

    Clearwater, Florida, 33756

  • Study site

    Cleveland, Ohio, 44106

  • Study site

    Colorado Springs, Colorado, 80909

  • Study site

    Columbia, Maryland, 21044

  • Study site

    Columbus, Ohio, 43201

  • Study site

    Columbus, Ohio, 43221

  • Study site

    Convington, Louisiana, 70433

  • Study site

    Coral Springs, Florida, 33065

  • Study site

    Council Bluffs, Iowa, 51501

  • Study site

    Dallas, Texas, 75216

  • Study site

    Dallas, Texas, 75230

  • Study site

    Dallas, Texas, 75231

  • Study site

    Dallas, Texas, 75390-9063

  • Study site

    Danville, Pennsylvania, 17822

  • Study site

    Danville, Virginia, 24541

  • Study site

    Davenport, Iowa, 52803

  • Study site

    Dayton, Ohio, 45428

  • Study site

    Decatur, Georgia, 30033

  • Study site

    Denver, Colorado, 80218

  • Study site

    Denver, Colorado, 80220

  • Study site

    Des Moines, Iowa, 50314

  • Study site

    Doral, Florida, 33166

  • Study site

    Durham, North Carolina, 27704

  • Study site

    Durham, North Carolina, 27710

  • Study site

    Edgewater, Florida, 32141

  • Study site

    Elizabeth, Florida, 07202

  • Study site

    Elizabethtown, Kentucky, 42701

  • Study site

    Elkhart, Indiana, 46514

  • Study site

    Fall River, Massachusetts, 02720

  • Study site

    Flint, Michigan, 48423

  • Study site

    Fort Lauderdale, Florida, 33316

  • Study site

    Freemont, Nebraska, 68025

  • Study site

    Fresno, California, 93720

  • Study site

    Fullerton, California, 92835

  • Study site

    Gainesville, Florida, 32608

  • Study site

    Glendale, California, 91204

  • Study site

    Grapevine, Texas, 76051

  • Study site

    Great Falls, Montana, 59405

  • Study site

    Green Bay, Wisconsin, 54301

  • Study site

    Greenville, North Carolina, 27834

  • Study site

    Greer, South Carolina, 29651

  • Study site

    Gurnee, Illinois, 60031

  • Study site

    Hammond, Louisiana, 70403

  • Study site

    Harrisburg, Pennsylvania, 17112

  • Study site

    Hartford, Connecticut, 06102

  • Study site

    Hawaiian Gardens, California, 90716

  • Study site

    Hialeah, Florida, 33010

  • Study site

    Hollywood, Florida, 33021

  • Study site

    Houma, Louisiana, 70360

  • Study site

    Houston, Texas, 77002

  • Study site

    Houston, Texas, 77024

  • Study site

    Houston, Texas, 77030

  • Study site

    Houston, Texas, 77075

  • Study site

    Houston, Texas, 77090

  • Study site

    Huntington, West Virginia, 25701

  • Study site

    Hyannis, Massachusetts, 02601

  • Study site

    Indianapolis, Indiana, 46260

  • Study site

    Inglewood, California, 90301

  • Study site

    Jackson, Mississippi, 39216

  • Study site

    Jacksonville Beach, Florida, 32250

  • Study site

    Johnson City, Tennessee, 37604

  • Study site

    Kalamazoo, Michigan, 49048

  • Study site

    Kerrville, Texas, 78028

  • Study site

    Kettering, Ohio, 45429

  • Study site

    Kingsport, Tennessee, 37660

  • Study site

    Kingwood, Texas, 77339

  • Study site

    La Crosse, Wisconsin, 54601-4795

  • Study site

    Lafayette, Indiana, 47905

  • Study site

    Lafayette, Louisiana, 70508

  • Study site

    Laguna Hills, California, 92653

  • Study site

    Lansing, Michigan, 48910

  • Study site

    Laplace, Louisiana, 70068

  • Study site

    Las Vegas, Nevada, 89102

  • Study site

    Layton, Utah, 84041

  • Study site

    Lexington, Tennessee, 38351

  • Study site

    Long Beach, California, 90822

  • Study site

    Los Angeles, California, 90033

  • Study site

    Lubbock, Texas, 79410

  • Study site

    Macon, Georgia, 31201

  • Study site

    Marion, Ohio, 43302

  • Study site

    Melbourne, Florida, 32901

  • Study site

    Mesa, Arizona, 85206

  • Study site

    Metarie, Louisiana, 70002

  • Study site

    Miami, Florida, 33136

  • Study site

    Miami, Florida, 33173

  • Study site

    Middleburg Heights, Ohio, 44130

  • Study site

    Milwaukee, Wisconsin, 53215

  • Study site

    Milwaukee, Wisconsin, 53295

  • Study site

    Mine Hill, New Jersey, 07803

  • Study site

    Minneapolis, Minnesota, 55407

  • Study site

    Minneapolis, Minnesota, 55415

  • Study site

    Minneapolis, Minnesota, 55417

  • Study site

    Miramar, Florida, 33025

  • Study site

    Mobile, Alabama, 36617

  • Study site

    Mobile, Alabama, 36693

  • Study site

    Murray, Utah, 84157

  • Study site

    Naples, Florida, 34102

  • Study site

    Nashville, Tennessee, 37203

  • Study site

    Natrona Heights, Pennsylvania, 15065

  • Study site

    New Orleans, Louisiana, 70112

  • Study site

    New Orleans, Louisiana, 70121

  • Study site

    New York, New York, 10021

  • Study site

    New York, New York, 10025

  • Study site

    New York, New York, 10029

  • Study site

    New York, New York, 10032

  • Study site

    Newark, New Jersey, 07103

  • Study site

    Northridge, California, 91325

  • Study site

    Ocala, Florida, 34471

  • Study site

    Odessa, Texas, 79761

  • Study site

    Oklahoma City, Oklahoma, 73103

  • Study site

    Omaha, Nebraska, 68114

  • Study site

    Omaha, Nebraska, 68131

  • Study site

    Opelousas, Louisiana, 70570

  • Study site

    Orange, California, 92868

  • Study site

    Orlando, Florida, 32806

  • Study site

    Owensboro, Kentucky, 42303

  • Study site

    Oxon Hill, Maryland, 20745

  • Study site

    Panama City, Florida, 32401

  • Study site

    Pawtucket, Rhode Island, 02860

  • Study site

    Petoskey, Michigan, 49770

  • Study site

    Philadelphia, Pennsylvania, 19106

  • Study site

    Philadelphia, Pennsylvania, 19107

  • Study site

    Philadelphia, Pennsylvania, 19140

  • Study site

    Phoenix, Arizona, 85023

  • Study site

    Phoenix, Arizona, 85029

  • Study site

    Picayune, Mississippi, 39466

  • Study site

    Plano, Texas, 75024

  • Study site

    Pomona, California, 91767

  • Study site

    Portland, Oregon, 97239

  • Study site

    Pottstown, Pennsylvania, 19464

  • Study site

    Providence, Rhode Island, 02903

  • Study site

    Providence, Rhode Island, 02906

  • Study site

    Redondo Beach, California, 90277

  • Study site

    Roanoke, Virginia, 24104

  • Study site

    Rochester, Minnesota, 55905

  • Study site

    Rocky Mount, North Carolina, 27804

  • Study site

    Royal Oak, Michigan, 48073

  • Study site

    Saginaw, Michigan, 48602

  • Study site

    Saginaw, Michigan, 48604

  • Study site

    Saint Cloud, Minnesota, 56362

  • Study site

    Saint Paul, Minnesota, 55102

  • Study site

    Salinas, California, 93901

  • Study site

    Salisbury, Maryland, 21801

  • Study site

    San Antonio, Texas, 78205

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Antonio, Texas, 78258

  • Study site

    San Diego, California, 92103

  • Study site

    San Francisco, California, 94115

  • Study site

    Santa Ana, California, 92704

  • Study site

    Sarasota, Florida, 34239

  • Study site

    Sarasota, Florida, 34292

  • Study site

    Seaford, Delaware, 19973

  • Study site

    Shreveport, Louisiana, 71101

  • Study site

    Shreveport, Louisiana, 71105

  • Study site

    Slidell, Louisiana, 70458

  • Study site

    Somerset, New Jersey, 08873

  • Study site

    Springfield, Ohio, 45505

  • Study site

    St. Petersburg, Florida, 33701

  • Study site

    St. Petersburg, Florida, 33709

  • Study site

    Stamford, Connecticut, 06905

  • Study site

    Suffern, New York, 10901

  • Study site

    Sylmar, California, 91342

  • Study site

    Syracuse, New York, 13210

  • Study site

    Tampa, Florida, 33613

  • Study site

    The Bronx, New York, 10469

  • Study site

    Thousand Oaks, California, 91360

  • Study site

    Toledo, Ohio, 43608

  • Study site

    Tomball, Texas, 77375

  • Study site

    Torrance, California, 90502

  • Study site

    Trinity, Florida, 34652

  • Study site

    Troy, New York, 12180

  • Study site

    Tucson, Arizona, 85712

  • Study site

    Tucson, Arizona, 85724-5078

  • Study site

    Tullahoma, Tennessee, 37388

  • Study site

    Tulsa, Oklahoma, 74104

  • Study site

    Upper Darby, Pennsylvania, 19082

  • Study site

    Ventura, California, 90265

  • Study site

    Vero Beach, Florida, 32960

  • Study site

    Victoria, Texas, 77901

  • Study site

    Washington, Missouri, 63090

  • Study site

    Winston-Salem, North Carolina, 27103

  • Study site

    Worcester, Massachusetts, 01604

  • Study site

    Zachary, Louisiana, 70791

Other trials in United States

Canada62 sites
  • Study site

    Bathurst, New Brunswick, E2A 1A9

  • Study site

    Brampton, Ontario, L6W2X7

  • Study site

    Brampton, Ontario, L6Z 4N5

  • Study site

    Bridgewater, Nova Scotia, B4V 3N2

  • Study site

    Burlington, Ontario, L7M 4Y1

  • Study site

    Burlington, Ontario, L7R4EZ

  • Study site

    Cambridge, Ontario, N1R 6V6

  • Study site

    Cambridge, Ontario, N1R 7R1

  • Study site

    Charlottetown, Prince Edward Island, C1A 8T5

  • Study site

    Chicoutimi, Quebec, G7H 5H6

  • Study site

    Chicoutimi, Quebec, G7H 7Y8

  • Study site

    Edmonton, Alberta, T5H 3V9

  • Study site

    Edmonton, Alberta, T6G1Z1

  • Study site

    Edmonton, Alberta, T6K 4C1

  • Study site

    Fort Eire, Ontario, L2A1Z3

  • Study site

    Gatineau, Quebec, J8Y 6S9

  • Study site

    Granby, Quebec, J2G 1T7

  • Study site

    Granby, Quebec, J2G 8Z9

  • Study site

    Greater Sudbury, Ontario, P3C 5K7

  • Study site

    Greater Sudbury, Ontario, P3E 3B8

  • Study site

    Greater Sudbury, Ontario, P3E 5J1

  • Study site

    Halifax, Nova Scotia, B3H 2Y9

  • Study site

    Hamilton, Ontario, L8L 2X2

  • Study site

    Kingston, Ontario, K7L 5G2

  • Study site

    Kitchener, Ontario, N2M 1B2

  • Study site

    Laval, Quebec, H7M 3L9

  • Study site

    Lévis, Quebec, G6V 4Z5

  • Study site

    London, Ontario, N6A 4L6

  • Study site

    London, Ontario, N6C 5J1

  • Study site

    Longueuil, Quebec, J4M 2X1

  • Study site

    Mississauga, Ontario, L4T2J2

  • Study site

    Mississauga, Ontario, L5B 2P7

  • Study site

    Moncton, New Brunswick, E1G 1A7

  • Study site

    Moncton, New Brunswick, E1L 2Z3

  • Study site

    Montreal, Quebec, H1T 1C8

  • Study site

    Montreal, Quebec, H2K 4L5

  • Study site

    Montreal, Quebec, H3G 1A4

  • Study site

    Montreal, Quebec, H4J 1C5

  • Study site

    New Westminster, British Columbia, V3L 3W4

  • Study site

    Newmarket, Ontario, L3Y 8C3

  • Study site

    Oshawa, Ontario, L1H 1B9

  • Study site

    Québec, Quebec, G1G 3Z4

  • Study site

    Québec, Quebec, G1N 4V3

  • Study site

    Red Deer, Alberta, T4N 6R2

  • Study site

    Saint John, New Brunswick, E2L 4L2

  • Study site

    Saint-Charles-Borromée, Quebec, J6E 6J2

  • Study site

    Saint-Jérôme, Quebec, J7Z 5T3

  • Study site

    Saint-Lambert, Quebec, J4P 2H4

  • Study site

    Saint-Laurent, Quebec, H4T 1Z9

  • Study site

    Saint-Léonard, Quebec, H1S 3A9

  • Study site

    Sherbrooke, Quebec, J1H 5N4

  • Study site

    Sherbrooke, Quebec, J1J 2E3

  • Study site

    Smiths Falls, Ontario, K7A 4W8

  • Study site

    St. John's, Newfoundland and Labrador, A1E2C2

  • Study site

    Ste. Foy, Quebec, G1V 4G5

  • Study site

    Surrey, British Columbia, V3V 1Z2

  • Study site

    Terrebonne, Quebec, J6V 2H2

  • Study site

    Thunder Bay, Ontario, P7B 6V4

  • Study site

    Toronto, Ontario, M5B 1W8

  • Study site

    Trois-Rivières, Quebec, G8Z 3R9

  • Study site

    Val DOr, Quebec, J9P 3Y1

  • Study site

    Vaudreuil-Dorion, Quebec, J7V 8P9

Other trials in Canada

Poland52 sites
  • Study site

    £ódx, 91-347

  • Study site

    Bêdzin, 42-500

  • Study site

    Bialystok, 15-276

  • Study site

    Bielsko-Biala, 43-316

  • Study site

    Bydgoszcz, 85-826

  • Study site

    Bydgoszcz, 85-863

  • Study site

    Bytom, 41-902

  • Study site

    Cracow, 30-092

  • Study site

    Gdansk, 80-126

  • Study site

    Gdansk, 80-952

  • Study site

    Gdynia, 81-402

  • Study site

    Gdynia, 81-423

  • Study site

    Gdynia, 81-472

  • Study site

    Gdynia, 81-519

  • Study site

    Gorlice, 38-300

  • Study site

    Grodzisk Mazowiecki, 05-754

  • Study site

    Katowice, 40-005

  • Study site

    Kędzierzyn-Koźle, 47-200

  • Study site

    Kielce, 25-315

  • Study site

    Krakow, 30-082

  • Study site

    Krakow, 31-202

  • Study site

    Krakow, 31-351

  • Study site

    Kutno, 99-300

  • Study site

    Libiąż, 32-590

  • Study site

    Lodz, 91-302

  • Study site

    Lodz, 91-490

  • Study site

    Lublin, 20-059

  • Study site

    Lublin, 20-834

  • Study site

    Nowa Sól, 67-100

  • Study site

    Nysa, 48-303

  • Study site

    Oława, 55-200

  • Study site

    Olesnica, Spalice, 56-400

  • Study site

    Olsztyn, 10-561

  • Study site

    Poznan, 61-848

  • Study site

    Puławy, 24-100

  • Study site

    Radom, 26-600

  • Study site

    Rzeszów, 35301

  • Study site

    Swidnica, 58-100

  • Study site

    Tarnów, 33-100

  • Study site

    Torun, 87-100

  • Study site

    Ustroń, 43-450

  • Study site

    Ustroñ, 43-450

  • Study site

    Warsaw, 02-097

  • Study site

    Warsaw, 02-637

  • Study site

    Warsaw, 03-242

  • Study site

    Warsaw, 03-599

  • Study site

    Warsaw, 04-141

  • Study site

    Wola, 43-225

  • Study site

    Wroclaw, 50-981

  • Study site

    Zamość, 22-400

  • Study site

    Żarów, 58-130

  • Study site

    Zgorzelec, 59-900

Other trials in Poland

China40 sites
  • Study site

    Baotou, 014040

  • Study site

    Beijing, 100020

  • Study site

    Beijing, 100029

  • Study site

    Beijing, 100038

  • Study site

    Beijing, 100050

  • Study site

    Beijing, 100088

  • Study site

    Beijing, 100101

  • Study site

    Beijing, 10029

  • Study site

    Beijing, 100730

  • Study site

    Beijing, 100853

  • Study site

    Beijng, 100700

  • Study site

    Changsha, 410007

  • Study site

    Changsha, 410011

  • Study site

    Changsha, 410013

  • Study site

    Chengdu, 610041

  • Study site

    Dalian, 116011

  • Study site

    Daqing, 163001

  • Study site

    Guangzhou, 510030

  • Study site

    Guangzhou, 510080

  • Study site

    Hangzhou, 310003

  • Study site

    Hangzhou, 310013

  • Study site

    Hangzhou, 310016

  • Study site

    Jinan, 250012

  • Study site

    Nanjing, 210009

  • Study site

    Nanning, 530021

  • Study site

    Qingdao, 266011

  • Study site

    Shanghai, 200001

  • Study site

    Shanghai, 200011

  • Study site

    Shanghai, 200030

  • Study site

    Shanghai, 200031

  • Study site

    Shanghai, 200040

  • Study site

    Shanghai, 200065

  • Study site

    Shanghai, 200072

  • Study site

    Shanghai, 200233

  • Study site

    Shenyang, 110004

  • Study site

    Shenyang, 110016

  • Study site

    Shijiazhuang, 050082

  • Study site

    Tianjin, 300014

  • Study site

    Wuhan, 430071

  • Study site

    Xi'an, 710061

Other trials in China

Germany40 sites
  • Study site

    Bad Krozingen, 79189

  • Study site

    Bad Nauheim, 61231

  • Study site

    Bad Oeynhausen, 32545

  • Study site

    Bad Rothenfelde, 49124

  • Study site

    Berlin, 12203

  • Study site

    Berlin, 12559

  • Study site

    Berlin, 13187

  • Study site

    Berlin, 13353

  • Study site

    Berlin, 14050

  • Study site

    Bernried, 82347

  • Study site

    Bochum, 44789

  • Study site

    Bonn, 53127

  • Study site

    Brandenburg, 14770

  • Study site

    Burg, 03096

  • Study site

    Cologne, 50923

  • Study site

    Dortmund, 44137

  • Study site

    Düsseldorf, 40225

  • Study site

    Essen, 45122

  • Study site

    Frankfurt, 65929

  • Study site

    Fulda, 36043

  • Study site

    Fürth, 90766

  • Study site

    Halle, 06120

  • Study site

    Hamburg, 20099

  • Study site

    Hanover, 30167

  • Study site

    Heidelberg, 69126

  • Study site

    Homburg/Saar, 66424

  • Study site

    Kiel, 24105

  • Study site

    Lahr, 77933

  • Study site

    Langen, 63225

  • Study site

    Mainz, 55131

  • Study site

    Mannheim, 68167

  • Study site

    Mönchengladbach, 41063

  • Study site

    München, 80336

  • Study site

    Münster, 48149

  • Study site

    Nienburg, 31582

  • Study site

    Pirna, 01796

  • Study site

    Regensburg, 93053

  • Study site

    Rotenburg (Wümme), 36199

  • Study site

    Rüdersdorf, 15562

  • Study site

    Wuppertal, 42117

Other trials in Germany

India40 sites
  • Study site

    Ahmedabad, 380005

  • Study site

    Ahmedabad, 380014

  • Study site

    Ahmedabad, 380015

  • Study site

    Ahmedabad, 380051

  • Study site

    Bangalore, 560038

  • Study site

    Bangalore, 560060

  • Study site

    Bangalore, 560099

  • Study site

    Banglore, 560034

  • Study site

    Belagavi, 590001

  • Study site

    Belagavi, 590010

  • Study site

    Chennai, 600100

  • Study site

    Gūrgaon, 122001

  • Study site

    Hyderabad, 500001

  • Study site

    Hyderabad, 500004

  • Study site

    Hyderabad, 500024

  • Study site

    Hyderabad, 500034

  • Study site

    Hyderabad, 500063

  • Study site

    Indore, 452001

  • Study site

    Jaipur, 302004

  • Study site

    Kochi, Kerala, 682304

  • Study site

    Kochi, 682041

  • Study site

    Kolkata, 700020

  • Study site

    Lucknow, 226014

  • Study site

    Madurai, 625107

  • Study site

    Mangalore, 575 002

  • Study site

    Mangalore, 575001

  • Study site

    Mangalore, 575002

  • Study site

    Mumbai, 400012

  • Study site

    Mumbai, 400051

  • Study site

    Mysore, 570004

  • Study site

    Nagpur, 440008

  • Study site

    Nagpur, 440010

  • Study site

    New Delhi, 110060

  • Study site

    Palakkad, 678013

  • Study site

    Pune, Maharashtra, 411011

  • Study site

    Pune, 411 001

  • Study site

    Pune, 411004

  • Study site

    Pune, 411030

  • Study site

    Secunderabad, 500003

  • Study site

    Trivandeum, 695011

Other trials in India

Brazil37 sites
  • Study site

    Belo Horizonte, Minas Gerais, 30110-068

  • Study site

    Belo Horizonte, Minas Gerais, 30150-221

  • Study site

    Belo Horizonte, Minas Gerais, 30150-240

  • Study site

    Brasília, Federal District, 71625-009

  • Study site

    Campina Grande do Sul, Paraná, 83430-000

  • Study site

    Campinas, São Paulo, 13024-011

  • Study site

    Campinas, São Paulo, 13060-803

  • Study site

    Campo Grande, Mato Grosso do Sul, 79070900

  • Study site

    Cariacica, Espírito Santo, 29151920

  • Study site

    Curitiba, Paraná, 80220-000

  • Study site

    Curitiba, Paraná, 80320-320

  • Study site

    Curitiba, Paraná, 80730-150

  • Study site

    Fortaleza, Ceará, 60115282

  • Study site

    Fortaleza, Ceará, 60430-370

  • Study site

    Fortaleza, Ceará, 60430970

  • Study site

    Fortaleza, Ceará, 60840285

  • Study site

    Goiânia, Goiás, 74823-470

  • Study site

    Natal, Rio Grande do Norte, 59020-100

  • Study site

    Passo Fundo, Rio Grande do Sul, 99010-080

  • Study site

    Porto Alegre, Rio Grande do Sul, 90020-090

  • Study site

    Porto Alegre, Rio Grande do Sul, 90035-003

  • Study site

    Porto Alegre, Rio Grande do Sul, 90035-170

  • Study site

    Porto Alegre, Rio Grande do Sul, 90110-270

  • Study site

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Study site

    Porto Alegre, Rio Grande do Sul, 90620-001

  • Study site

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Study site

    Recife, Pernambuco, 50100-060

  • Study site

    Rio de Janeiro, Rio de Janeiro, 22240-006

  • Study site

    Rio de Janeiro, Rio de Janeiro, 22271-100

  • Study site

    Salvador, Estado de Bahia, 40010020

  • Study site

    São José, Santa Catarina, 88103-460

  • Study site

    Sao Jose Do Rio Preto, Santa Catarina, 15015-210

  • Study site

    São José do Rio Preto, São Paulo, 15090-000

  • Study site

    São Paulo, São Paulo, 01244-030

  • Study site

    São Paulo, São Paulo, 05403-000

  • Study site

    São Paulo, São Paulo, 1506000

  • Study site

    Uberlândia, Minas Gerais, 38400-368

Other trials in Brazil

Mexico33 sites
  • Study site

    Acapulco, 39670

  • Study site

    Aguascalientes, 20127

  • Study site

    Aguascalientes, 20230

  • Study site

    Chihuahua City, 31000

  • Study site

    Chihuahua City, 31217

  • Study site

    Ciudad Juárez, 32420

  • Study site

    Cuernavaca, 62250

  • Study site

    Culiacán, 80020

  • Study site

    Durango, 34000

  • Study site

    Durango, 34080

  • Study site

    Guadalajara, 44210

  • Study site

    Guadalajara, 44600

  • Study site

    Guadalajara, 44650

  • Study site

    Mexico City, 10700

  • Study site

    Mexico City, 11650

  • Study site

    Mexico City, 14000

  • Study site

    Mexico City, 14050

  • Study site

    Mexico City, 14080

  • Study site

    Monterrey, 64060

  • Study site

    Monterrey, 64460

  • Study site

    Monterrey, 64640

  • Study site

    Monterrey, 64710

  • Study site

    Pachuca, 42000

  • Study site

    Puebla City, 72490

  • Study site

    Puerto Vallarta, 48328

  • Study site

    Querétaro, 76000

  • Study site

    San Luis Potosi S.l.p., 78240

  • Study site

    Tampico, 89000

  • Study site

    Tijuana, 22010

  • Study site

    Tlalnepantla, 54055

  • Study site

    Veracruz, 91700

  • Study site

    Xalapa, 91020

  • Study site

    Zapopan, 45200

Other trials in Mexico

Spain33 sites
  • Study site

    A Coruña, La Coruña, 15006

  • Study site

    Alcorcón, Madrid, 28922

  • Study site

    Alicante, Alicante, 03010

  • Study site

    Almería, Almeria, 04009

  • Study site

    Barcelona, Barcelona, 08003

  • Study site

    Barcelona, Barcelona, 08025

  • Study site

    Barcelona, Barcelona, 08035

  • Study site

    Bilbao, Vizcaya, 48013

  • Study site

    Ferrol, La Coruña, 15405

  • Study site

    Figueres, Girona, 17600

  • Study site

    Granollers, Barcelona, 08400

  • Study site

    Guadalajara, Guadalajara, 19002

  • Study site

    Jerez de la Frontera, Cadiz, 11402

  • Study site

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Study site

    Lugo, Lugo, 27004

  • Study site

    Madrid, Madrid, 28007

  • Study site

    Madrid, Madrid, 28040

  • Study site

    Madrid, Madrid, 28041

  • Study site

    Málaga, Malaga, 29010

  • Study site

    Murcia, Murcia, 30008

  • Study site

    Oviedo, Principality of Asturias, 33006

  • Study site

    Reus, Tarragona, 43201

  • Study site

    Sabadell, Barcelona, 08208

  • Study site

    Salamanca, Salamanca, 37007

  • Study site

    San Sebastián de los Reyes, Madrid, 28702

  • Study site

    Santiago de Compostela, La Coruña, 15706

  • Study site

    Seville, Sevilla, 41071

  • Study site

    Tarragona, Tarragona, 43007

  • Study site

    Terrassa, Barcelona, 08227

  • Study site

    Torrevieja, Alicante, 03186

  • Study site

    Valencia, Valencia, 46014

  • Study site

    Valencia, Valencia, 46017

  • Study site

    Vitoria-Gasteiz, Alava, 01009

Other trials in Spain

United Kingdom29 sites
  • Study site

    Abano Terme, 35031

  • Study site

    Antrim, BT41 2RL

  • Study site

    Ayr, KA6 6DX

  • Study site

    Basildon, SS16 5NL

  • Study site

    Bath, BA1 3NG

  • Study site

    Belfast, BT13 3BW

  • Study site

    Belfast, BT47 6SB

  • Study site

    Brighton, BN2 1ES

  • Study site

    Cambridge, CB2 0QQ

  • Study site

    Craigavon, BT63 5QQ

  • Study site

    Derby, DE22 3DT

  • Study site

    Glasgow, G11 6NK

  • Study site

    Harrow, HA1 3UJ

  • Study site

    Inverness, IV2 4RE

  • Study site

    Isle of Wight, 30 5TG.

  • Study site

    Isleworth, TW7 6AF

  • Study site

    Leeds

  • Study site

    London, E1 2AT

  • Study site

    Manchester, M13 9WL

  • Study site

    Middlesex, UB1 3HW

  • Study site

    Newcastle upon Tyne, NE7 7DN

  • Study site

    Northampton, NN1 5BD

  • Study site

    Paddington, W2 1LA

  • Study site

    Plymouth, PL6 8BX

  • Study site

    Poole, BH15 2JB

  • Study site

    Romford, RM7 0AG

  • Study site

    Stoker on Trent, ST4 6QG

  • Study site

    West Bromwich, B71 4HJ

  • Study site

    Wrexham, LL137TD

Other trials in United Kingdom

Argentina28 sites
  • Study site

    Buenos Aires, 1425DES

  • Study site

    Buenos Aires, 1428

  • Study site

    Buenos Aires, C1155ADP

  • Study site

    Buenos Aires, c1181ach

  • Study site

    Buenos Aires, C1425AGC

  • Study site

    Buenos Aires, C1426AGU

  • Study site

    Buenos Aires, C1437BZL

  • Study site

    Caba, C1119ACN

  • Study site

    Caba, C1405BCK

  • Study site

    Caba, C1428DCO

  • Study site

    Capital Federal, 1180

  • Study site

    Ciudad Autonoma Bs As, C1280AEB

  • Study site

    Córdoba, 5000

  • Study site

    Córdoba, 5009

  • Study site

    Córdoba, X5000EPU

  • Study site

    Coronel Suárez, B7540GDH

  • Study site

    Corrientes, W3400AMZ

  • Study site

    Haedo, B1706AJU

  • Study site

    Mendoza, 5500

  • Study site

    Morón, 1708

  • Study site

    Rosario, 2000

  • Study site

    Rosario, S2000DIF

  • Study site

    Rosario, S2002OUR

  • Study site

    Salta, 4400

  • Study site

    San Miguel de Tucumán, 4000

  • Study site

    Santa Fe, 3000

  • Study site

    Santiago del Estero, G4200AQK

  • Study site

    Zárate, 2800

Other trials in Argentina

South Korea27 sites
  • Study site

    Busan, 47392

  • Study site

    Busan, 49267

  • Study site

    Busan, 602-739

  • Study site

    Daegu, 41931

  • Study site

    Daegu, 705-717

  • Study site

    Daejeon, 35015

  • Study site

    Gwangju, 61469

  • Study site

    Gyeonggi-do, 10380

  • Study site

    Gyeonggi-do, 14647

  • Study site

    Gyeonggi-do, 431-070

  • Study site

    Gyeonggi-do, 443-380

  • Study site

    Incheon, 400-711

  • Study site

    Incheon, 405-760

  • Study site

    Jeollabuk-do, 561-712

  • Study site

    Kyonggi-do, 411-719

  • Study site

    Seoul, 03080

  • Study site

    Seoul, 06973

  • Study site

    Seoul, 130-702

  • Study site

    Seoul, 136-705

  • Study site

    Seoul, 140-743

  • Study site

    Seoul, 150-950

  • Study site

    Seoul, 152-703

  • Study site

    Seoul, 156-707

  • Study site

    Suwon, 442-723

  • Study site

    Uijongbu, 480-130

  • Study site

    Ulsan, 44033

  • Study site

    Wŏnju, 220-701

Other trials in South Korea

Australia22 sites
  • Study site

    Adelaide, South Australia, 5000

  • Study site

    Ballarat, Victoria, 3353

  • Study site

    Bankstown, New South Wales, 2200

  • Study site

    Concord, New South Wales, 2139

  • Study site

    Darlinghurst, New South Wales, 2010

  • Study site

    Douglas, Queensland, 4184

  • Study site

    Elizabeth Vale, South Australia, 5112

  • Study site

    Garran, Australian Capital Territory, 2605

  • Study site

    Geelong, Victoria, 3220

  • Study site

    Liverpool BC, New South Wales, 1871

  • Study site

    Milton, Queensland, 4064

  • Study site

    New Lambton, New South Wales, 2305

  • Study site

    Penrith, New South Wales, 2751

  • Study site

    Redcliffe, Queensland, 4020

  • Study site

    Richmond, Victoria, 3121

  • Study site

    Shepparton, Victoria, 3630

  • Study site

    Southport, Queensland, 4215

  • Study site

    St Leonards, New South Wales, 2065

  • Study site

    Sydney, New South Wales, 2217

  • Study site

    Wollongong, New South Wales, 2500

  • Study site

    Woodville, South Australia, 5011

  • Study site

    Woolloongabba, Queensland, 4102

Other trials in Australia

France17 sites
  • Study site

    Albi, 81000

  • Study site

    Besançon, 25000

  • Study site

    Bron, 69677

  • Study site

    Cambrai, 59407

  • Study site

    Créteil, 94010

  • Study site

    Dijon, 21079

  • Study site

    Lagny-sur-Marne, 77405

  • Study site

    Le Coudray, 28630

  • Study site

    Le Plessis-Robinson, 92350

  • Study site

    Marseille, 13285

  • Study site

    Montfermeil, 93370

  • Study site

    Montpellier, 34295

  • Study site

    Paris, 75651

  • Study site

    Paris, 75908

  • Study site

    Pessac, 3600

  • Study site

    Saint-Herblain, 44800

  • Study site

    Valenciennes, 59322

Other trials in France

Hungary17 sites
  • Study site

    Balatonfüred, 8230

  • Study site

    Budapest, 1032

  • Study site

    Budapest, 1085

  • Study site

    Budapest, 1088

  • Study site

    Budapest, 1096

  • Study site

    Budapest, 1097

  • Study site

    Budapest, 1115

  • Study site

    Debrecen, 4032

  • Study site

    Gyula, 5700

  • Study site

    Kaposvár, 7400

  • Study site

    Kecskemét, 6000

  • Study site

    Miskolc, 3526

  • Study site

    Pécs, 7643

  • Study site

    Székeshehérvár, 8000

  • Study site

    Szolnok, 5004

  • Study site

    Szombathely, 9700

  • Study site

    Zalaegerszeg, 8900

Other trials in Hungary

Italy16 sites
  • Study site

    Bentivoglio, Emilia-Romagna, 40010

  • Study site

    Bergamo, Lombardy, 24128

  • Study site

    Cittadella, Veneto, 35013

  • Study site

    Ferrara, Emilia-Romagna, 44100

  • Study site

    Legnano, Lombardy, 20025

  • Study site

    Mantua, Lombardy, 46100

  • Study site

    Milan, Lombardy, 20138

  • Study site

    Milan, Lombardy, 20162

  • Study site

    Naples, Campania, 80131

  • Study site

    Pavia, Lombardy, 27100

  • Study site

    Perugia, Umbria, 06100

  • Study site

    Pozzuoli, Campania, 80078

  • Study site

    Reggio Emilia, Emilia-Romagna, 42123

  • Study site

    Rome, Lazio, 00189

  • Study site

    Rovigo, Veneto, 45100

  • Study site

    Udine, Friuli Venezia Giulia, 33100

Other trials in Italy

Netherlands14 sites
  • Study site

    AC Amsterdam, 1091

  • Study site

    Amstelveen, 1186 AH

  • Study site

    Amsterdam, 1066 EC

  • Study site

    Amsterdam, 1105 AZ

  • Study site

    Hoorn, 1625 HV

  • Study site

    Leiden, 2333 ZA

  • Study site

    Maastricht, 6202 AZ

  • Study site

    Nieuwegein, 3435 CM

  • Study site

    Nijmegen, 6500 HB

  • Study site

    Purmerend, 1441 RN

  • Study site

    Tilburg, 5042 AD

  • Study site

    Weert, 6001 BE

  • Study site

    Zaandam, 1502 DV

  • Study site

    Zwolle, 8011 JW

Other trials in Netherlands

Thailand14 sites
  • Study site

    Amphur Mae-Rim, 50180

  • Study site

    Amphur Muang, 57000

  • Study site

    Amphur Muang, 65000

  • Study site

    Bangkok, 10300

  • Study site

    Bangkok, 10330

  • Study site

    Bangkok, 10400

  • Study site

    Bangkok, 10700

  • Study site

    Changwat Sara Buri, 18000

  • Study site

    Chiang Mai, 50200

  • Study site

    Chon Buri, 20000

  • Study site

    Khon Kaen, 40002

  • Study site

    Khonkaen, 40000

  • Study site

    Klong Luang, 12120

  • Study site

    Phitsanulok, 65000

Other trials in Thailand

Czechia13 sites
  • Study site

    Brno, 625 00

  • Study site

    Brno, CA-656 91

  • Study site

    Hradec Králové, 50005

  • Study site

    Jindřichův Hradec, 37701

  • Study site

    Kladno, 27259

  • Study site

    Olomouc, 77520

  • Study site

    Prague, 128 00

  • Study site

    Prague, 128 08

  • Study site

    Prague, 14021

  • Study site

    Tábor, 390 03

  • Study site

    Teplice, 41529

  • Study site

    Trutnov, 541 01

  • Study site

    Znojmo, 669 02

Other trials in Czechia

Sweden12 sites
  • Study site

    Danderyd Stockholm, SE-182 88

  • Study site

    Gothenburg, 413 45

  • Study site

    Halmstad, 301 85

  • Study site

    Kalmar, 391 85

  • Study site

    Karlstad, 65185

  • Study site

    Kristianstad, 29185

  • Study site

    Malmö, 20502

  • Study site

    Östersund, 83 183

  • Study site

    Skellefteå, 0910-77

  • Study site

    Skövde, 541 85

  • Study site

    Stockholm, 11883

  • Study site

    Stockholm, 17176

Other trials in Sweden

Romania11 sites
  • Study site

    Brasov, 500360

  • Study site

    Bucharest, 010628

  • Study site

    Bucharest, 020992

  • Study site

    Buzău, 120203

  • Study site

    Cluj-Napoca, 400006

  • Study site

    Craiova, 200147

  • Study site

    Galati, 800371

  • Study site

    Oradea, 410169

  • Study site

    Ploieşti, 100163

  • Study site

    Târgu Mureş, 540124

  • Study site

    Timișoara, 300310

Other trials in Romania

Malaysia8 sites
  • Study site

    George Town, 10990

  • Study site

    Kelantan, 16150

  • Study site

    Kota Bharu, 15586

  • Study site

    Kuala Lumpur, 50400

  • Study site

    Kuala Lumpur, 59100

  • Study site

    Kuantan, 25100

  • Study site

    Sarawak, Sarawak, 93586

  • Study site

    Serdang, 43000

Other trials in Malaysia

New Zealand7 sites
  • Study site

    Auckland

  • Study site

    Christchurch, 8140

  • Study site

    Hamiton, 3240

  • Study site

    Lower Hutt, 5040

  • Study site

    Nelson, 7001

  • Study site

    Palmerston North, 4410

  • Study site

    Tauranga, 3112

Other trials in New Zealand

Denmark6 sites
  • Study site

    Aalborg, 9000

  • Study site

    Copenhagen

  • Study site

    Fredericia, 7000

  • Study site

    Herning, 7400

  • Study site

    Odense, 5000 C

  • Study site

    Slagelse, 4200

Other trials in Denmark

Ireland6 sites
  • Study site

    Ballinasloe

  • Study site

    Dublin, 7

  • Study site

    Dublin, 8

  • Study site

    Dublin, 9

  • Study site

    Galway

  • Study site

    Tallaght Dublin, D24

Other trials in Ireland

Russia4 sites
  • Study site

    Moscow, 111539

  • Study site

    Saint Petersburg, 193312

  • Study site

    Saint Petersburg, 194291

  • Study site

    Saint Petersburg, 197341

Other trials in Russia

Grenada1 site
  • Study site

    Toulouse, 31059

About this study

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)

This double-blind, parallel, two-arm study will evaluate the potential to reduce cardiovascular risk, the tolerability and long-term safety profile of aleglitazar compared to placebo on top of standard care in patients with recent acute coronary syndrome (ACS) and type 2 diabetes mellitus. Patients will be randomized to 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 at least 2.5 years.

Being tested
Aleglitazar, Placebo
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AleglitazarDrug

    aleglitazar 150 micrograms po daily

  • PlaceboDrug

    placebo control po daily

Study groups in NCT01042769
Study groupRoleWhat they receive
AleglitazarExperimentalNot described
Receives: Drug: Aleglitazar
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effect on cardiovascular death, non-fatal myocardial infarction and non-fatal stroke

    Measured: Throughout study, approximately 4.5 years

Secondary outcomes (3)
  1. Effects on other cardiovascular endpoints

    Measured: Throughout study, approximately 4.5 years

  2. Glycemic control, lipoprotein profile, blood pressure, biomarkers of cardiovascular risk

    Measured: Throughout study, months 1, 3, 6, 9, 12 and then every 6 months thereafter

  3. Tolerability and long-term safety profile

    Measured: Throughout study, approximately 4.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2010 (estimated)
  2. Study startFeb 2010
  3. Primary completionNov 2013
  4. Study completionNov 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
7,226 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01042769
Sponsor's protocol ID
BC22140
Other IDs
2009-012269-71, 2009
Status last verified
Nov 2016
First submitted
5 Jan 2010
Last updated
2 Nov 2016
Results posted
No

Publications

  • Schrieks IC, Nozza A, Stahli BE, Buse JB, Henry RR, Malmberg K, Neal B, Nicholls SJ, Ryden L, Mellbin L, Svensson A, Wedel H, Weichert A, Lincoff AM, Tardif JC, Grobbee DE, Schwartz GG. Adiponectin, Free Fatty Acids, and Cardiovascular Outcomes in Patients With Type 2 Diabetes and Acute Coronary Syndrome. Diabetes Care. 2018 Aug;41(8):1792-1800. doi: 10.2337/dc18-0158. Epub 2018 Jun 14.

    PubMed 29903845
  • Lincoff AM, Tardif JC, Schwartz GG, Nicholls SJ, Ryden L, Neal B, Malmberg K, Wedel H, Buse JB, Henry RR, Weichert A, Cannata R, Svensson A, Volz D, Grobbee DE; AleCardio Investigators. Effect of aleglitazar on cardiovascular outcomes after acute coronary syndrome in patients with type 2 diabetes mellitus: the AleCardio randomized clinical trial. JAMA. 2014 Apr 16;311(15):1515-25. doi: 10.1001/jama.2014.3321.

    PubMed 24682069
  • Lincoff AM, Tardif JC, Neal B, Nicholls SJ, Ryden L, Schwartz GG, Malmberg K, Buse JB, Henry RR, Wedel H, Weichert A, Cannata R, Grobbee DE. Evaluation of the dual peroxisome proliferator-activated receptor alpha/gamma agonist aleglitazar to reduce cardiovascular events in patients with acute coronary syndrome and type 2 diabetes mellitus: rationale and design of the AleCardio trial. Am Heart J. 2013 Sep;166(3):429-34. doi: 10.1016/j.ahj.2013.05.013. Epub 2013 Jul 26.

    PubMed 24016490

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aleglitazar in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 810 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 810 sites in United States, Canada, Poland, China, Germany and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect on cardiovascular death, non-fatal myocardial infarction and non-fatal stroke (time frame: Throughout study, approximately 4.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01042769, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.

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