AzTrials
AzTrials

Type 2 Diabetes MellitusPhase 3ALTITUDENCT00549757

Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints (Core and Extension Phases)

A Phase 3 study testing Aliskiren in people with Type 2 Diabetes Mellitus and Cardiovascular Disease, run by Novartis Pharmaceuticals at 776 sites in 37 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The purpose of this study was to determine whether, in patients with type 2 diabetes and pre-existing disease of the heart and the circulatory system and/or the kidney, aliskiren at a target dose of 300 mg once daily (compared to placebo), on top of conventional treatment, reduces death and disease caused by the… Read more about this study

Who is it for?
Ages 35 years and older
What is being tested?
Aliskiren
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
8,606 participants
Where
776 sitesin 37 countries
Study dates
Oct 2007to Feb 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • Type 2 diabetes and at least one of the following:
  • Macroalbuminuria and an eGFR ≥30 mL/min/1.73 m2
  • Microalbuminuria and a reduced kidney function (eGFR eGFR ≥30 and <60 mL/min/1.73 m2)
  • A history of CV disease (previous MI, previous stroke, heart failure, coronary artery disease, history of percutaneous coronary intervention, angiography proven stenosis ≥50% in at least one coronary artery and a reduced kidney function (eGFR ≥30 and <60 mL/min/1.73 m2)
  • Concomitant treatment should follow national guidelines and must include either an Angiotensin-converting-enzyme-inhibitor (ACEi) or an Angiotensin-receptor-blocker (ARB) but not both.

Who cannot join

  • Type 1 diabetes mellitus
  • Cardiovascular event or procedure ≤ 3 months prior to Visit 1
  • Unstable serum creatinine
  • Hypertension: Mean sitting systolic blood pressure (msSBP) ≥ 135 and < 170 mmHg or Mean sitting diastolic blood pressure (msDBP) ≥ 85 and < 110 mmHg unless treated with at least 3 anti-hypertensive medications
  • Hypertension msSBP ≥ 170 or msDBP ≥ 110 mmHg
  • Baseline Serum Potassium > 5.0 mmol/L
Show all 12Show fewer
  • Patients who are treated with two renin-angiotensin-aldosterone-system-blockers
  • Patients with NYHA class III or IV heart failure
  • Known renal artery stenosis
  • Previous randomization into the AVOID trial (CSPP100C2201)
  • Aliskiren or aliskiren containing fixed combination products must not be used
  • Other protocol-defined inclusion/exclusion criteria applied

Trial locations and contacts

776 sites in 37 countries.

776 sites in 37 countries

United States118 sites

  • Novartis Investigative Site

    Aiken, South Carolina, 29801

  • Novartis Investigative Site

    Albany, New York, 12206

  • Novartis Investigative Site

    Albuquerque, New Mexico, 87106

  • Novartis Investigative Site

    Alexandria, Virginia, 22304-2315

  • Novartis Investigative Site

    Allentown, Pennsylvania, 18103

  • Novartis Investigative Site

    Amarillo, Texas, 79106

  • Novartis Investigative Site

    Ann Arbor, Michigan, 48109

  • Novartis Investigative Site

    Appleton, Wisconsin, 54911

  • Novartis Investigative Site

    Atlanta, Georgia, 30309

  • Novartis Investigative Site

    Augusta, Georgia, 30904

  • Novartis Investigative Site

    Augusta, Georgia, 30909

  • Novartis Investigative Site

    Austin, Texas, 78731

  • Novartis Investigative Site

    Aventura, Florida, 33180

  • Novartis Investigative Site

    Baltimore, Maryland, 21204

  • Novartis Investigative Site

    Belzoni, Mississippi, 39038

  • Novartis Investigative Site

    Bennington, Vermont, 05201

  • Novartis Investigative Site

    Birmingham, Alabama, 35209

  • Novartis Investigative Site

    Birmingham, Alabama, 35235

  • Novartis Investigative Site

    Boca Raton, Florida, 33433

  • Novartis Investigative Site

    Bridgeport, Connecticut, 06610

  • Novartis Investigative Site

    Burke, Virginia, 22015

  • Novartis Investigative Site

    Burlingame, California, 94010

  • Novartis Investigative Site

    Burlington, Massachusetts, 01803

  • Novartis Investigative Site

    Burlington, Vermont, 05401

  • Novartis Investigative Site

    Champaign, Illinois, 61820

  • Novartis Investigative Site

    Charleston, South Carolina, 29425

  • Novartis Investigative Site

    Charleston, West Virginia, 25301

  • Novartis Investigative Site

    Cincinnati, Ohio, 45236

  • Novartis Investigative Site

    Cleveland, Ohio, 44115

  • Novartis Investigative Site

    Collierville, Tennessee, 38017

  • Novartis Investigative Site

    Columbia, South Carolina, 29201

  • Novartis Investigative Site

    Cumming, Georgia, 30041

  • Novartis Investigative Site

    Dallas, Texas, 75226

  • Novartis Investigative Site

    Dallas, Texas, 75231

  • Novartis Investigative Site

    Dallas, Texas, 75235

  • Novartis Investigative Site

    Dallas, Texas, 75390

  • Novartis Investigative Site

    Denver, Colorado, 80209

  • Novartis Investigative Site

    Detroit, Michigan, 48202

  • Novartis Investigative Site

    Detroit, Michigan, 48236

  • Novartis Investigative Site

    Dover, New Hampshire, 03820-2403

  • Novartis Investigative Site

    Fayetteville, Arkansas, 72703

  • Novartis Investigative Site

    Fort Lauderdale, Florida, 33311

  • Novartis Investigative Site

    Fremont, Nebraska, 68025

  • Novartis Investigative Site

    Fullerton, California, 92835

  • Novartis Investigative Site

    Greenville, South Carolina, 29605

  • Novartis Investigative Site

    Gulfport, Mississippi, 39501

  • Novartis Investigative Site

    Haverhill, Massachusetts, 01830

  • Novartis Investigative Site

    Hollywood, Florida, 33021

  • Novartis Investigative Site

    Honolulu, Hawaii, 96813

  • Novartis Investigative Site

    Honolulu, Hawaii, 96814

  • Novartis Investigative Site

    Houston, Texas, 77030

  • Novartis Investigative Site

    Huntington Beach, California, 92648

  • Novartis Investigative Site

    Huntsville, Alabama, 35801

  • Novartis Investigative Site

    Irving, Texas, 75039

  • Novartis Investigative Site

    Jackson, Mississippi, 39209

  • Novartis Investigative Site

    Jacksonville, Florida, 32204

  • Novartis Investigative Site

    Jacksonville, Florida, 32205

  • Novartis Investigative Site

    Jacksonville, Florida, 32209

  • Novartis Investigative Site

    Jacksonville, Florida, 32216

  • Novartis Investigative Site

    Jamaica Plain, Massachusetts, 02130

  • Novartis Investigative Site

    Kalamazoo, Michigan, 49048

  • Novartis Investigative Site

    Lake Zurich, Illinois, 60047

  • Novartis Investigative Site

    Lancaster, Pennsylvania, 17604

  • Novartis Investigative Site

    Lansdale, Pennsylvania, 19446

  • Novartis Investigative Site

    Lauderdale Lakes, Florida, 33313

  • Novartis Investigative Site

    Livonia, Michigan, 48154

  • Novartis Investigative Site

    Louisville, Kentucky, 40202

  • Novartis Investigative Site

    Lyndhurst, Ohio, 44124

  • Novartis Investigative Site

    McAllen, Texas, 78501

  • Novartis Investigative Site

    Melrose Park, Pennsylvania, 19027

  • Novartis Investigative Site

    Metairie, Louisiana, 70006

  • Novartis Investigative Site

    Minneapolis, Minnesota, 55404

  • Novartis Investigative Site

    Minneapolis, Minnesota, 55455

  • Novartis Investigative Site

    Mobile, Alabama, 36608

  • Novartis Investigative Site

    Mobile, Alabama, 36617

  • Novartis Investigative Site

    Montgomery, Alabama, 36106

  • Novartis Investigative Site

    Muscle Shoals, Alabama, 35662

  • Novartis Investigative Site

    Natick, Massachusetts, 01760

  • Novartis Investigative Site

    Norman, Oklahoma, 73069

  • Novartis Investigative Site

    North Dartmouth, Massachusetts, 02747

  • Novartis Investigative Site

    North Richland Hills, Texas, 76180

  • Novartis Investigative Site

    Oakland, California, 94609

  • Novartis Investigative Site

    Oklahoma City, Oklahoma, 73112

  • Novartis Investigative Site

    Omaha, Nebraska, 68131

  • Novartis Investigative Site

    Orangeburg, South Carolina, 29115

  • Novartis Investigative Site

    Pasadena, California, 91101

  • Novartis Investigative Site

    Pensacola, Florida, 32504

  • Novartis Investigative Site

    Peoria, Arizona, 85381

  • Novartis Investigative Site

    Peoria, Illinois, 61615

  • Novartis Investigative Site

    Philadelphia, Pennsylvania, 19138

  • Novartis Investigative Site

    Phoenix, Arizona, 85032

  • Novartis Investigative Site

    Plano, Texas, 75024

  • Novartis Investigative Site

    Plantation, Florida, 33324

  • Novartis Investigative Site

    Princeton Junction, New Jersey, 08550

  • Novartis Investigative Site

    Renton, Washington, 98055

  • Novartis Investigative Site

    Riverside, California, 92501

  • Novartis Investigative Site

    Rochester, New York, 14607

  • Novartis Investigative Site

    Saint Louis Park, Minnesota, 55416

  • Novartis Investigative Site

    San Antonio, Texas, 78207

  • Novartis Investigative Site

    San Antonio, Texas, 78218

  • Novartis Investigative Site

    San Antonio, Texas, 78229-4801

  • Novartis Investigative Site

    Slidell, Louisiana, 70458

  • Novartis Investigative Site

    Spring Valley, California, 91978-1522

  • Novartis Investigative Site

    Springfield, Missouri, 65807

  • Novartis Investigative Site

    St Louis, Missouri, 63110-1093

  • Novartis Investigative Site

    St Louis, Missouri, 63141

  • Novartis Investigative Site

    Temple, Texas, 76508-0002

  • Novartis Investigative Site

    Topeka, Kansas, 66606

  • Novartis Investigative Site

    Torrance, California, 90502

  • Novartis Investigative Site

    Tucson, Arizona, 85712

  • Novartis Investigative Site

    Tucson, Arizona, 85741

  • Novartis Investigative Site

    Tulsa, Oklahoma, 74133

  • Novartis Investigative Site

    Walnut Creek, California, 94598

  • Novartis Investigative Site

    Waltham, Massachusetts, 02154

  • Novartis Investigative Site

    Warwick, Rhode Island, 02886

  • Novartis Investigative Site

    West Palm Beach, Florida, 33401

  • Novartis Investigative Site

    Worcester, Massachusetts, 01609

  • Novartis Investigative Site

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Spain65 sites

  • Novartis Investigative Site

    A Coruña, Galicia, 15010

  • Novartis Investigative Site

    Alaquàs, Valencia, 46970

  • Novartis Investigative Site

    Alcázar de San Juan, Castille-La Mancha, 13600

  • Novartis Investigative Site

    Alcorcón, Madrid, 28922

  • Novartis Investigative Site

    Alfaro, La Rioja, 26540

  • Novartis Investigative Site

    Alicante, Valencia, 03004

  • Novartis Investigative Site

    Alzira, Valencia, 46600

  • Novartis Investigative Site

    Aranda de Duero, Castille and León, 09400

  • Novartis Investigative Site

    Arganda, Madrid, 28500

  • Novartis Investigative Site

    Barcelona, Catalonia, 08025

  • Novartis Investigative Site

    Barcelona, Catalonia, 08905

  • Novartis Investigative Site

    Begonte, Galicia, 27373

  • Novartis Investigative Site

    Benidorm, Valencia, 03550

  • Novartis Investigative Site

    Cadiz, Andalusia, 11010

  • Novartis Investigative Site

    Civdad Real, Madrid, 13002

  • Novartis Investigative Site

    Donostia / San Sebastian, Basque Country, 20014

  • Novartis Investigative Site

    El Puerto de Santa María, Andalusia, 11500

  • Novartis Investigative Site

    Ferrol, Galicia, 15405

  • Novartis Investigative Site

    Girona, Catalonia, 17007

  • Novartis Investigative Site

    Granada, Andalusia, 18014

  • Novartis Investigative Site

    Hospitalet de Llbregat, 08902

  • Novartis Investigative Site

    Jerez de la Frontera, Andalusia, 11407

  • Novartis Investigative Site

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Novartis Investigative Site

    L'Hospitalet de Llobregat

  • Novartis Investigative Site

    La Pobla Llarga, Catalonia, 46670

  • Novartis Investigative Site

    Llança, Catalonia, 17490

  • Novartis Investigative Site

    Logroño, La Rioja, 26005

  • Novartis Investigative Site

    Madrid, Madrid, 28034

  • Novartis Investigative Site

    Madrid, Madrid, 28035

  • Novartis Investigative Site

    Madrid, Madrid, 28040

  • Novartis Investigative Site

    Madrid, Madrid, 28041

  • Novartis Investigative Site

    Madrid, Madrid, 28046

  • Novartis Investigative Site

    Madrid, Madrid, 28770

  • Novartis Investigative Site

    Málaga, Andalusia, 29010

  • Novartis Investigative Site

    Málaga, Andalusia, 29018

  • Novartis Investigative Site

    Manresa, Catalonia, 08240

  • Novartis Investigative Site

    Mérida, Extremadura, 06800

  • Novartis Investigative Site

    Miranda de Ebro, Castille and León, 09200

  • Novartis Investigative Site

    Mollet del Vallès, Catalonia, 08100

  • Novartis Investigative Site

    Murcia, Madrid, 30007

  • Novartis Investigative Site

    Oviedo, Principality of Asturias, 33006

  • Novartis Investigative Site

    Oviedo, Principality of Asturias, 33008

  • Novartis Investigative Site

    Oviedo, Principality of Asturias, 33010

  • Novartis Investigative Site

    Palma de Mallorca, Balearic Islands

  • Novartis Investigative Site

    Plentzia, Basque Country, 48620

  • Novartis Investigative Site

    Pontevedra, Galicia, 36071

  • Novartis Investigative Site

    Port de Sagunt, Valencia, 46520

  • Novartis Investigative Site

    Quart de Poblet, Valencia, 46930

  • Novartis Investigative Site

    Rubí, Catalonia, 08191

  • Novartis Investigative Site

    Sabadell, Barcelona, 08208

  • Novartis Investigative Site

    Sanlúcar de Barrameda, Andalusia, 11540

  • Novartis Investigative Site

    Santa Coloma de Gramanet, Catalonia, 08923

  • Novartis Investigative Site

    Santiago de Compostela, Galicia, 15706

  • Novartis Investigative Site

    Seville, Andalusia, 41009

  • Novartis Investigative Site

    Tàrrega, Catalonia, 25300

  • Novartis Investigative Site

    Valencia, Valencia, 46010

  • Novartis Investigative Site

    Valencia, Valencia, 46011

  • Novartis Investigative Site

    Valencia, Valencia, 46014

  • Novartis Investigative Site

    Valencia, Valencia, 46017

  • Novartis Investigative Site

    Valencia, Valencia, 46019

  • Novartis Investigative Site

    Vic, Catalonia, 08500

  • Novartis Investigative Site

    Vigo, Galicia, 36200

  • Novartis Investigative Site

    Villabona, Basque Country, 20150

  • Novartis Investigative Site

    Xixona, Valencia, 03100

  • Novartis Investigative Site

    Zumarraga, Basque Country, 20700

Other trials in Spain

Italy56 sites

  • Novartis Investigative Site

    Arenzano, GE, 16011

  • Novartis Investigative Site

    Belluno, BL, 32100

  • Novartis Investigative Site

    Bergamo, BG, 24128

  • Novartis Investigative Site

    Bologna, BO, 40138

  • Novartis Investigative Site

    Campobasso, CB, 86100

  • Novartis Investigative Site

    Caserta, CE, 81100

  • Novartis Investigative Site

    Casorate Primo, PV, 27022

  • Novartis Investigative Site

    Catanzaro, CZ, 88100

  • Novartis Investigative Site

    Cava de' Tirreni, SA, 84013

  • Novartis Investigative Site

    Chieti, CH, 66100

  • Novartis Investigative Site

    Cona, FE, 44100

  • Novartis Investigative Site

    Cosenza, CS, 87100

  • Novartis Investigative Site

    Cuneo, CN, 12100

  • Novartis Investigative Site

    Florence, FI, 50134

  • Novartis Investigative Site

    Foggia, FG, 71100

  • Novartis Investigative Site

    Genova, GE, 16132

  • Novartis Investigative Site

    Isernia, 86170

  • Novartis Investigative Site

    L’Aquila, AQ, 67100

  • Novartis Investigative Site

    Lecco, LC, 23900

  • Novartis Investigative Site

    Mercato San Severino, SA, 84085

  • Novartis Investigative Site

    Milan, MI, 20123

  • Novartis Investigative Site

    Milan, MI, 20132

  • Novartis Investigative Site

    Milan, MI, 20146

  • Novartis Investigative Site

    Milan, MI, 20157

  • Novartis Investigative Site

    Monza, MB, 20900

  • Novartis Investigative Site

    Naples, 80131

  • Novartis Investigative Site

    Olbia, SS, 07026

  • Novartis Investigative Site

    Palermo, PA, 90127

  • Novartis Investigative Site

    Parma, PR, 43100

  • Novartis Investigative Site

    Passirana Di Rho, MI, 20017

  • Novartis Investigative Site

    Pavia, PV, 27100

  • Novartis Investigative Site

    Perugia, PG, 06100

  • Novartis Investigative Site

    Pisa, PI, 56124

  • Novartis Investigative Site

    Pisa, PI, 56126

  • Novartis Investigative Site

    Pordenone, PN, 33170

  • Novartis Investigative Site

    Pozzilli, IS, 86077

  • Novartis Investigative Site

    Ravenna, RA, 48100

  • Novartis Investigative Site

    Roma, RM, 00122

  • Novartis Investigative Site

    Roma, RM, 00133

  • Novartis Investigative Site

    Roma, RM, 00157

  • Novartis Investigative Site

    Roma, RM, 00161

  • Novartis Investigative Site

    Roma, RM, 00163

  • Novartis Investigative Site

    Roma, RM, 00186

  • Novartis Investigative Site

    Roma, RM, 00189

  • Novartis Investigative Site

    Salerno, SA, 84125

  • Novartis Investigative Site

    San Daniele del Friuli, UD, 33038

  • Novartis Investigative Site

    Sassari, SS, 07100

  • Novartis Investigative Site

    Siena, SI, 53100

  • Novartis Investigative Site

    Stradella, PV, 27049

  • Novartis Investigative Site

    Torino, TO, 10126

  • Novartis Investigative Site

    Torino, TO, 10128

  • Novartis Investigative Site

    Torino, TO, 10154

  • Novartis Investigative Site

    Udine, UD, 33100

  • Novartis Investigative Site

    Venezia, VE, 30174

  • Novartis Investigative Site

    Verona, VR, 37126

  • Novartis Investigative Site

    Vittorio Veneto, TV, 31029

Other trials in Italy

Germany50 sites

  • Novartis Investigative Site

    Aschaffenburg, 63739

  • Novartis Investigative Site

    Aschaffenburg, 63741

  • Novartis Investigative Site

    Aßlar, 35614

  • Novartis Investigative Site

    Bad Oeynhausen, 32545

  • Novartis Investigative Site

    Barsinghausen, 30890

  • Novartis Investigative Site

    Bensheim, 64625

  • Novartis Investigative Site

    Berlin, 13055

  • Novartis Investigative Site

    Berlin, 13597

  • Novartis Investigative Site

    Berlin, 14193

  • Novartis Investigative Site

    Bonn, 53105

  • Novartis Investigative Site

    Bottrop, 46242

  • Novartis Investigative Site

    Bremen, 28277

  • Novartis Investigative Site

    Bretten, 75015

  • Novartis Investigative Site

    Cloppenburg, 49661

  • Novartis Investigative Site

    Dippoldiswalde, 01744

  • Novartis Investigative Site

    Dresden, 01127

  • Novartis Investigative Site

    Dresden, 01307

  • Novartis Investigative Site

    Düsseldorf, 40210

  • Novartis Investigative Site

    Essen, 45127

  • Novartis Investigative Site

    Essen, 45134

  • Novartis Investigative Site

    Essen, 45138

  • Novartis Investigative Site

    Fuldatal, 34233

  • Novartis Investigative Site

    Göttingen, 37075

  • Novartis Investigative Site

    Hagen, 58095

  • Novartis Investigative Site

    Hamburg, 22335

  • Novartis Investigative Site

    Hamburg, 22393

  • Novartis Investigative Site

    Hanover, 30625

  • Novartis Investigative Site

    Heidelberg, 69120

  • Novartis Investigative Site

    Heilbronn, 74072

  • Novartis Investigative Site

    Heilbronn, 74076

  • Novartis Investigative Site

    Ingelheim, 55218

  • Novartis Investigative Site

    Jena, 07743

  • Novartis Investigative Site

    Kassel, 34117

  • Novartis Investigative Site

    Krefeld, 47798

  • Novartis Investigative Site

    Magdeburg, 39120

  • Novartis Investigative Site

    Mainz, 55131

  • Novartis Investigative Site

    Messkirch, 88605

  • Novartis Investigative Site

    Muehldorf Am Inn, 84453

  • Novartis Investigative Site

    Neuwied, 56564

  • Novartis Investigative Site

    Offenbach, 63065

  • Novartis Investigative Site

    Rehburg-Loccum, 31547

  • Novartis Investigative Site

    Riesa, 01587

  • Novartis Investigative Site

    Saint Ingbert - Oberwuerzbach, 66386

  • Novartis Investigative Site

    Schauenburg-Elgershausen, 34270

  • Novartis Investigative Site

    Schwabenheim, 55270

  • Novartis Investigative Site

    Ursensollen, 92289

  • Novartis Investigative Site

    Wetter, 58300

  • Novartis Investigative Site

    Wiehl, 51674

  • Novartis Investigative Site

    Wiesbaden, 65183

  • Novartis Investigative Site

    Würzburg, 97072

Other trials in Germany

China45 sites

  • Novartis Investigative Site

    Beijing, Beijing Municipality, 100044

  • Novartis Investigative Site

    Beijing, Beijing Municipality, 100083

  • Novartis Investigative Site

    Beijing, Beijing Municipality, 100730

  • Novartis Investigative Site

    Beijing, 100028

  • Novartis Investigative Site

    Beijing, 100029

  • Novartis Investigative Site

    Beijing, 100034

  • Novartis Investigative Site

    Beijing, 100088

  • Novartis Investigative Site

    Beijing, 100176

  • Novartis Investigative Site

    Beijing

  • Novartis Investigative Site

    Changsha, Hunan, 410008

  • Novartis Investigative Site

    Changsha, Hunan, 410011

  • Novartis Investigative Site

    Chengdu, Sichuan, 610041

  • Novartis Investigative Site

    Chengdu, 610072

  • Novartis Investigative Site

    Chongqing, Chongqing Municipality, 400016

  • Novartis Investigative Site

    Chongqing, Chongqing Municipality

  • Novartis Investigative Site

    Chongqing, 400038

  • Novartis Investigative Site

    Dalian, Liaoning, 116011

  • Novartis Investigative Site

    Dalian

  • Novartis Investigative Site

    Fuzhou, Fujian, 350025

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510180

  • Novartis Investigative Site

    Guangzhou, 510000

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310003

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310009

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310013

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310016

  • Novartis Investigative Site

    Harbin, Heilongjiang, 150001

  • Novartis Investigative Site

    Harbin, Heilongjiang, 150086

  • Novartis Investigative Site

    Kunming, Yunnan, 650101

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210006

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210008

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210009

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210029

  • Novartis Investigative Site

    Qingdao, Shandong, 266011

  • Novartis Investigative Site

    Shanghai, 200003

  • Novartis Investigative Site

    Shanghai, 200025

  • Novartis Investigative Site

    Shanghai, 200031

  • Novartis Investigative Site

    Shanghai, 200233

  • Novartis Investigative Site

    Shenyang, Liaoning, 110003

  • Novartis Investigative Site

    Shijiazhuang, Hebei, 050051

  • Novartis Investigative Site

    Suzhou, Jiangsu, 215004

  • Novartis Investigative Site

    Tianjin, 300052

  • Novartis Investigative Site

    Tianjin, 300142

  • Novartis Investigative Site

    Wuhan, Hubei, 430030

  • Novartis Investigative Site

    Xi’an, Shanxi, 710032

  • Novartis Investigative Site

    Xi’an, Shanxi, 710061

Other trials in China

Japan36 sites

  • Novartis Investigative Site

    Aira, Kagoshima-ken, 899-5431

  • Novartis Investigative Site

    Asahi, Chiba, 289-2511

  • Novartis Investigative Site

    Asahikawa, Hokkaido, 078-8211

  • Novartis Investigative Site

    Bunkyo-ku, Tokyo, 113-8655

  • Novartis Investigative Site

    Chuo-ku, Tokyo, 103-0002

  • Novartis Investigative Site

    Isehara, Kanagawa, 259-1131

  • Novartis Investigative Site

    Kasuga, Fukuoka, 816-0864

  • Novartis Investigative Site

    Kawasaki, Kanagawa, 210-0852

  • Novartis Investigative Site

    Kitakyushu, Fukuoka, 800-0296

  • Novartis Investigative Site

    Kōriyama, Fukushima, 963-8851

  • Novartis Investigative Site

    Kyoto, Kyoto, 612-8555

  • Novartis Investigative Site

    Kyoto, Kyoto, 615-0035

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 451-8511

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 455-8530

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 460-0001

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 462-0802

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 462-0825

  • Novartis Investigative Site

    Ohtsu-city, Shiga, 520-2192

  • Novartis Investigative Site

    Ōita, Oita Prefecture, 870-0039

  • Novartis Investigative Site

    Ōita, Oita Prefecture, 870-0192

  • Novartis Investigative Site

    Okayama, Okayama-ken, 700-8558

  • Novartis Investigative Site

    Okayama, Okayama-ken, 701-1192

  • Novartis Investigative Site

    Sapporo, Hokkaido, 003-0023

  • Novartis Investigative Site

    Sapporo, Hokkaido, 060-0033

  • Novartis Investigative Site

    Sapporo, Hokkaido, 060-8648

  • Novartis Investigative Site

    Sendai, Miyagi, 980-8574

  • Novartis Investigative Site

    Shimizu, Shizuoka, 411-8611

  • Novartis Investigative Site

    Suwa, Nagano, 392-8510

  • Novartis Investigative Site

    Takamatsu, Kagawa-ken, 7600076

  • Novartis Investigative Site

    Takaoka, Toyama, 933-0955

  • Novartis Investigative Site

    Takatsuki, Osaka, 569-1096

  • Novartis Investigative Site

    Tokorozawa, Saitama, 351-1151

  • Novartis Investigative Site

    Toride, Ibaraki, 302-0022

  • Novartis Investigative Site

    Toyonaka, Osaka, 561-0871

  • Novartis Investigative Site

    Yao, Osaka, 581-0011

  • Novartis Investigative Site

    Yatsushiro, Kumamoto, 866-8660

Other trials in Japan

Canada35 sites

  • Novartis Investigative Site

    Bay Roberts, Newfoundland and Labrador, A0A 1G0

  • Novartis Investigative Site

    Brampton, Ontario, L6Z 4N5

  • Novartis Investigative Site

    Burlington, Ontario, L7M 4Y1

  • Novartis Investigative Site

    Cambridge, Ontario, N1R 6V6

  • Novartis Investigative Site

    Courtice, Ontario, L1E 3C3

  • Novartis Investigative Site

    Edmonton, Alberta, T5J 3N4

  • Novartis Investigative Site

    Edmonton, Alberta, T5N 3Y6

  • Novartis Investigative Site

    Etobicoke, Ontario, M9R 4E1

  • Novartis Investigative Site

    Greenfield Park, Quebec, J4V 2H1

  • Novartis Investigative Site

    London, Ontario, N6A 4G5

  • Novartis Investigative Site

    Mirabel, Quebec, J7J 2K8

  • Novartis Investigative Site

    Montreal, Quebec, H1T 2M4

  • Novartis Investigative Site

    North Bay, Ontario, P1B 2H3

  • Novartis Investigative Site

    Oakville, Ontario, L6H 3P1

  • Novartis Investigative Site

    Oshawa, Ontario, L1J 2K1

  • Novartis Investigative Site

    Ottawa, Ontario, K1H 7W9

  • Novartis Investigative Site

    Ouest-Montreal, H2W1R7

  • Novartis Investigative Site

    Pointe-Claire, Quebec, H9R 4S3

  • Novartis Investigative Site

    Québec, Quebec, G1G 3Y8

  • Novartis Investigative Site

    Sainte-Foy, Quebec, G1V 4G5

  • Novartis Investigative Site

    Sainte-Foy, Quebec, G1W 4R4

  • Novartis Investigative Site

    Saskatoon, Saskatchewan, S7H 5M3

  • Novartis Investigative Site

    Scarborough Village, Ontario, M1H 3G4

  • Novartis Investigative Site

    Sherbrooke, Quebec, J1G 5K2

  • Novartis Investigative Site

    St. John's, Newfoundland and Labrador, A1E 4J8

  • Novartis Investigative Site

    Ste-Foy, Quebec, G1V 4G2

  • Novartis Investigative Site

    Thornhill, Ontario, L4J 8L7

  • Novartis Investigative Site

    Toronto, Ontario, M4G 3E8

  • Novartis Investigative Site

    Toronto, Ontario, M4N 3M5

  • Novartis Investigative Site

    Toronto, Ontario, M5C 2T2

  • Novartis Investigative Site

    Toronto, Ontario, N6G 4X8

  • Novartis Investigative Site

    Trois-Rivières, Quebec, G8Z 3R9

  • Novartis Investigative Site

    Vancouver, British Columbia, V6E 1M7

  • Novartis Investigative Site

    Winnipeg, Manitoba, R2V 4W3

  • Novartis Investigative Site

    Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

Netherlands32 sites

  • Novartis Investigative Site

    Alkmaar, 1851 JD

  • Novartis Investigative Site

    Almelo, Netherlands, 7609 PP

  • Novartis Investigative Site

    Amersfoort, 3800 BM

  • Novartis Investigative Site

    Amsterdam, 1061 AE

  • Novartis Investigative Site

    Apeldoorn, 7334 DZ

  • Novartis Investigative Site

    Arnhem, 6815 AD

  • Novartis Investigative Site

    Breda, 4818 CK

  • Novartis Investigative Site

    Delft, 2625 AD

  • Novartis Investigative Site

    Den Helder, 1782 GZ

  • Novartis Investigative Site

    Deventer, 7416 SE

  • Novartis Investigative Site

    Doetinchem, 7009 BL

  • Novartis Investigative Site

    Dordrecht, 3318AT

  • Novartis Investigative Site

    Eindhoven, 5623 EJ

  • Novartis Investigative Site

    Eindhoven, 5631 BM

  • Novartis Investigative Site

    Goes, 4462 RA

  • Novartis Investigative Site

    Groningen, 9713 GZ

  • Novartis Investigative Site

    Heerlen, 6419 PC

  • Novartis Investigative Site

    Hoogeveen, 7909 AA

  • Novartis Investigative Site

    Hoogwoud, 1718 BG

  • Novartis Investigative Site

    Losser, 7581 BV

  • Novartis Investigative Site

    Meppel, 7943 KA

  • Novartis Investigative Site

    Nieuwegein, 3435 CM

  • Novartis Investigative Site

    Oude Pekela, 9665 AR

  • Novartis Investigative Site

    Rotterdam, 3015 CE

  • Novartis Investigative Site

    Rotterdam, 3045 PM

  • Novartis Investigative Site

    Rotterdam, 3083 AN

  • Novartis Investigative Site

    Tiel, 4002 WP

  • Novartis Investigative Site

    Utrecht, 3508 GA

  • Novartis Investigative Site

    Venlo, 5912 BL

  • Novartis Investigative Site

    Woerden, 3443 GG

  • Novartis Investigative Site

    Zwijndrecht, NL-3331 LZ

  • Novartis Investigative Site

    Zwolle, 8025 AB

Other trials in Netherlands

Argentina29 sites

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, C1120AAC

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, C1405BCH

  • Novartis Investigative Site

    Caba, Buenos Aires, 1428

  • Novartis Investigative Site

    Caba, Buenos Aires, C1181ACH

  • Novartis Investigative Site

    Caba, Buenos Aires, C1280AEB

  • Novartis Investigative Site

    Caba, Buenos Aires, C1408INH

  • Novartis Investigative Site

    Caba, Buenos Aires, C1416DRJ

  • Novartis Investigative Site

    Caba, Buenos Aires, C1425AST

  • Novartis Investigative Site

    Córdoba, Córdoba Province, 5000

  • Novartis Investigative Site

    Córdoba, Córdoba Province, X5000AAW

  • Novartis Investigative Site

    Córdoba, Córdoba Province, X5000EVQ

  • Novartis Investigative Site

    Córdoba, Córdoba Province, X5000FGG

  • Novartis Investigative Site

    Córdoba, Córdoba Province, X5000IUG

  • Novartis Investigative Site

    Córdoba, Córdoba Province, X5000JHQ

  • Novartis Investigative Site

    Córdoba, Córdoba Province, X5009BSN

  • Novartis Investigative Site

    Córdoba, Córdoba Province, X5016KEH

  • Novartis Investigative Site

    Corrientes, Corrientes Province, W3400

  • Novartis Investigative Site

    Florida, Buenos Aires, B1602BPD

  • Novartis Investigative Site

    Lanus, Buenos Aires, B8000XAV

  • Novartis Investigative Site

    Ramos Mejía, Buenos Aires, B1704ETD

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000AII

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000CXH

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000DFD

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2001ODA

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S200CVD

  • Novartis Investigative Site

    Santa Fe, Santa Fe Province, S3000FNF

  • Novartis Investigative Site

    Santa Fe, Santa Fe Province, S3000FSO

  • Novartis Investigative Site

    Santa Fe, Santa Fe Province, S3000FVA

  • Novartis Investigative Site

    Zárate, Buenos Aires, 2800

Other trials in Argentina

United Kingdom25 sites

  • Novartis Investigative Site

    Bath, BA2 3HT

  • Novartis Investigative Site

    Cardiff, CF14 4XN

  • Novartis Investigative Site

    Cardiff, CF5 4AD

  • Novartis Investigative Site

    Cornwall, England, PL23 1DT

  • Novartis Investigative Site

    Crawley, West Sussex, RH10 7DX

  • Novartis Investigative Site

    East Horsley, Surrey, KT24 6QT

  • Novartis Investigative Site

    Glasgow, Scotland, G12 8TA

  • Novartis Investigative Site

    Glasgow, G11 6NT

  • Novartis Investigative Site

    Glasgow, G21 3UW

  • Novartis Investigative Site

    Gravesend, Kent, DA1 24JW

  • Novartis Investigative Site

    High Wycombe, Buckinghamshire, HP11 2TT

  • Novartis Investigative Site

    Irvine, KA12 0AY

  • Novartis Investigative Site

    Lancashire, FY3 7EN

  • Novartis Investigative Site

    Lancashire, FY4 3AD

  • Novartis Investigative Site

    London, NW10 7NS

  • Novartis Investigative Site

    London, SE1 9RT

  • Novartis Investigative Site

    London, SW17 0QT

  • Novartis Investigative Site

    Manchester, M13 9NT

  • Novartis Investigative Site

    Merseyside, L7 8PX

  • Novartis Investigative Site

    Paignton, Devon, TQ4 5LA

  • Novartis Investigative Site

    Rugby, CV21 5 PX

  • Novartis Investigative Site

    Truro, Cornwall, TR1 3LJ

  • Novartis Investigative Site

    Vale of Glanmorgan, CF63 4AR

  • Novartis Investigative Site

    Welwyn Garden City, Hertfordshire, AL7 4HQ

  • Novartis Investigative Site

    Wrexham, LL13 7TD

Other trials in United Kingdom

Belgium22 sites

  • Novartis Investigative Site

    Bonheiden, 2820

  • Novartis Investigative Site

    Bruges, 8000

  • Novartis Investigative Site

    Brussels, 1070

  • Novartis Investigative Site

    Brussels, 1200

  • Novartis Investigative Site

    Brussels, 9100

  • Novartis Investigative Site

    Charleroi, 6000

  • Novartis Investigative Site

    De Pinte, 9840

  • Novartis Investigative Site

    Edegem, 2650

  • Novartis Investigative Site

    Genk, 3600

  • Novartis Investigative Site

    Ghent, 9000

  • Novartis Investigative Site

    Hasselt, 3500

  • Novartis Investigative Site

    Kortrijk, 8500

  • Novartis Investigative Site

    La Louvière, 7100

  • Novartis Investigative Site

    Leuven, 3000

  • Novartis Investigative Site

    Liège, 4000

  • Novartis Investigative Site

    Roeselare, 8800

  • Novartis Investigative Site

    Ronse, 9600

  • Novartis Investigative Site

    Seraing, 4100

  • Novartis Investigative Site

    Sint-Gillis-Waas, 9170

  • Novartis Investigative Site

    Turnhout, 2300

  • Novartis Investigative Site

    Vilvoorde, 1800

  • Novartis Investigative Site

    Willebroek, 2830

Other trials in Belgium

India20 sites

  • Novartis Investigative Site

    Ahmedabad, Gujarat, 380014

  • Novartis Investigative Site

    Bangalore, Karnataka, 560054

  • Novartis Investigative Site

    Bangalore, 560 034

  • Novartis Investigative Site

    Banglaore, Karnataka, 560038

  • Novartis Investigative Site

    Chennai, Tamil Nadu, 600013

  • Novartis Investigative Site

    Chennai, 600010

  • Novartis Investigative Site

    Chennai, 600086

  • Novartis Investigative Site

    Hyderabad, Andhra Pradesh, 500001

  • Novartis Investigative Site

    Hyderabad, Andhra Pradesh, 500012

  • Novartis Investigative Site

    Hyderabad, Andhra Pradesh, 500018

  • Novartis Investigative Site

    Hyderabad, Andhra Pradesh, India, 500034

  • Novartis Investigative Site

    Hyderabad, 500 063

  • Novartis Investigative Site

    Kochi, Kerala, 682 026

  • Novartis Investigative Site

    Kolkota, 700020

  • Novartis Investigative Site

    Mangalore, Karnataka, 575001

  • Novartis Investigative Site

    Mumbai, Maharashtra, 400008

  • Novartis Investigative Site

    New Delhi, 110 029

  • Novartis Investigative Site

    Pune, Maharashtra, 411011

  • Novartis Investigative Site

    Pune, Maharashtra, 411030

  • Novartis Investigative Site

    Vellore, Tamil Nadu, 632004

Other trials in India

Brazil17 sites

  • Novartis Investigative Site

    Belém, Pará, 66073-000

  • Novartis Investigative Site

    Campinas, São Paulo, 13060-904

  • Novartis Investigative Site

    Campinas, São Paulo, 13083-190

  • Novartis Investigative Site

    Fortaleza, Ceará, 60120-021

  • Novartis Investigative Site

    Fortaleza, Ceará, 60430-370

  • Novartis Investigative Site

    Juiz de Fora, Minas Gerais, 36036-110

  • Novartis Investigative Site

    Marília, São Paulo, 17519-030

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90020-090

  • Novartis Investigative Site

    Rio de Janeiro, Rio de Janeiro, 20020-020

  • Novartis Investigative Site

    Rio de Janeiro, Rio de Janeiro, 20551-030

  • Novartis Investigative Site

    Salvador, Estado de Bahia, 40050-410

  • Novartis Investigative Site

    Santos, São Paulo, 11045-904

  • Novartis Investigative Site

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

  • Novartis Investigative Site

    São Paulo, São Paulo, 04023-900

  • Novartis Investigative Site

    São Paulo, São Paulo, 05403-000

  • Novartis Investigative Site

    Sorocaba, São Paulo, 18030-210

  • Novartis Investigative Site

    Vitória, Espírito Santo, 29040-091

Other trials in Brazil

Slovakia17 sites

  • Novartis Investigative Site

    Banksa Bystrica, SK 97 517

  • Novartis Investigative Site

    Bratislava, Slovak Republic, 826 06

  • Novartis Investigative Site

    Bratislava, Slovakia, 811 08

  • Novartis Investigative Site

    Bratislava, 812 72

  • Novartis Investigative Site

    Bratislava, 81369

  • Novartis Investigative Site

    Bratislava, 833 48

  • Novartis Investigative Site

    Bratislava, 851 07

  • Novartis Investigative Site

    Košice, Slovak Republic, 040 22

  • Novartis Investigative Site

    Košice, 040 01

  • Novartis Investigative Site

    Ľubochňa, SK 03491

  • Novartis Investigative Site

    Lučenec, 98439

  • Novartis Investigative Site

    Martin, Slovakia, 03601

  • Novartis Investigative Site

    Nitra, Slovakia, 949 01

  • Novartis Investigative Site

    Piešťany, 921 01

  • Novartis Investigative Site

    Prievidza, 971 01

  • Novartis Investigative Site

    Trstená, 549 16

  • Novartis Investigative Site

    Žilina, Slovak Republic, 010 01

Other trials in Slovakia

Hungary16 sites

  • Novartis Investigative Site

    Baja, 6500

  • Novartis Investigative Site

    Balatonfüred, 8230

  • Novartis Investigative Site

    Budapest, 1062

  • Novartis Investigative Site

    Budapest, 1083

  • Novartis Investigative Site

    Budapest, 1085

  • Novartis Investigative Site

    Budapest, 1096

  • Novartis Investigative Site

    Budapest, 1115

  • Novartis Investigative Site

    Budapest, H-1032

  • Novartis Investigative Site

    Debrecen, 4004

  • Novartis Investigative Site

    Debrecen, 4032

  • Novartis Investigative Site

    Gyula, 5703

  • Novartis Investigative Site

    Kaposvár, 7400

  • Novartis Investigative Site

    Miskolc, 3526

  • Novartis Investigative Site

    Pécs, 7324

  • Novartis Investigative Site

    Szeged, 6720

  • Novartis Investigative Site

    Zalaegerszeg, 8900

Other trials in Hungary

South Korea16 sites

  • Novartis Investigative Site

    Ansan, Gyeonggi-do, 425-801

  • Novartis Investigative Site

    Anyang-si, Gyeonggi-do, 431-070

  • Novartis Investigative Site

    Bundang, Seongnam, 463-707

  • Novartis Investigative Site

    Busan, Busan, 602-739

  • Novartis Investigative Site

    Daejeon, 301-747

  • Novartis Investigative Site

    Incheon, 400-712

  • Novartis Investigative Site

    Pusan, 614-735

  • Novartis Investigative Site

    Seoul, Korea, 110 744

  • Novartis Investigative Site

    Seoul, Korea, 120-752

  • Novartis Investigative Site

    Seoul, Korea, 135-710

  • Novartis Investigative Site

    Seoul, 135-720

  • Novartis Investigative Site

    Seoul, 136 705

  • Novartis Investigative Site

    Seoul, 137-701

  • Novartis Investigative Site

    Seoul, 152-703

  • Novartis Investigative Site

    Seoul, 156-707

  • Novartis Investigative Site

    Taegu, 700 - 721

Other trials in South Korea

Switzerland15 sites

  • Novartis Investigative Site

    Ascona

  • Novartis Investigative Site

    Bern, 3010

  • Novartis Investigative Site

    Bolligen, Switzerland, 3065

  • Novartis Investigative Site

    Bruderholz, 4101

  • Novartis Investigative Site

    Estavayer-le-Lac, CH, 1470

  • Novartis Investigative Site

    Fribourg, 1700

  • Novartis Investigative Site

    La Chaux-de-Fonds, 2300

  • Novartis Investigative Site

    Lausanne, 1011

  • Novartis Investigative Site

    Lugano, 6900

  • Novartis Investigative Site

    Lugano, 6903

  • Novartis Investigative Site

    Renens, 1020

  • Novartis Investigative Site

    Sankt Gallen, 9007

  • Novartis Investigative Site

    Schaffhausen, 8200

  • Novartis Investigative Site

    Winterthur, Switzerland, 8400

  • Novartis Investigative Site

    Zurich, 8091

Other trials in Switzerland

Norway13 sites

  • Novartis Investigative Site

    Bergen, 5013

  • Novartis Investigative Site

    Fredrikstad, Norway, 1607

  • Novartis Investigative Site

    Hønefoss, 3515

  • Novartis Investigative Site

    Horten, Norway, 3191

  • Novartis Investigative Site

    Oslo, 0160

  • Novartis Investigative Site

    Skedsmokorset, 2020

  • Novartis Investigative Site

    Skien, Norway, 3722

  • Novartis Investigative Site

    Spikkestad, 3430

  • Novartis Investigative Site

    Stavanger, 4011

  • Novartis Investigative Site

    Svelvik, 3060

  • Novartis Investigative Site

    Tønsberg, 3103

  • Novartis Investigative Site

    Tromsø, NO-9038

  • Novartis Investigative Site

    Trondheim, NO-7011

Other trials in Norway

Portugal13 sites

  • Novartis Investigative Site

    Almada, 2801-951

  • Novartis Investigative Site

    Amadora, 2720-276

  • Novartis Investigative Site

    Coimbra, Portugal, 3000-075

  • Novartis Investigative Site

    Linda a Velha, 2799-523

  • Novartis Investigative Site

    Lisbon, Portugal, 1495-005

  • Novartis Investigative Site

    Lisbon, 1169-024

  • Novartis Investigative Site

    Lisbon, 1250-203

  • Novartis Investigative Site

    Lisbon, 1649-035

  • Novartis Investigative Site

    Matosinhos Municipality, 4454-509

  • Novartis Investigative Site

    Portimão, 8500-388

  • Novartis Investigative Site

    Porto, 4200-319

  • Novartis Investigative Site

    Santa Maria da Feira, 4520-211

  • Novartis Investigative Site

    Santarém, 2000-153

Other trials in Portugal

France12 sites

  • Novartis Investigative Site

    Besançon, 25030

  • Novartis Investigative Site

    Bondy, 93143

  • Novartis Investigative Site

    Corbeil-Essonnes, 91100

  • Novartis Investigative Site

    Grenoble, 38043

  • Novartis Investigative Site

    La Rochelle, 17019

  • Novartis Investigative Site

    Lagny-sur-Marne, 77405

  • Novartis Investigative Site

    Limoges, 87042

  • Novartis Investigative Site

    Lyon, 69394

  • Novartis Investigative Site

    Lyon, 69437

  • Novartis Investigative Site

    Paris, 75181

  • Novartis Investigative Site

    Paris, 75877

  • Novartis Investigative Site

    Poitiers, 86021

Other trials in France

Greece12 sites

  • Novartis Investigative Site

    Alexandroupoli, Greece, GR 68 100

  • Novartis Investigative Site

    Athens, Greece, GR 115 21

  • Novartis Investigative Site

    Athens, Greece, GR 115 27

  • Novartis Investigative Site

    Athens, Greece, GR 11527

  • Novartis Investigative Site

    Athens, GR 115 22

  • Novartis Investigative Site

    Athens

  • Novartis Investigative Site

    Athens - GR, 10676

  • Novartis Investigative Site

    Ioannina, GR 45500

  • Novartis Investigative Site

    Pátrai, 26500

  • Novartis Investigative Site

    Piraeurs, GR 184 54

  • Novartis Investigative Site

    Thessaloniki, Greece, 57001

  • Novartis Investigative Site

    Thessaloniki, Greece, GR 546 39

Other trials in Greece

Finland11 sites

  • Novartis Investigative Site

    Ekenäs, 10600

  • Novartis Investigative Site

    Helsinki, 00250

  • Novartis Investigative Site

    Hyvinkää, FIN-05850

  • Novartis Investigative Site

    Kajaani, FIN-87140

  • Novartis Investigative Site

    Kuopio, FIN-70211

  • Novartis Investigative Site

    Lohja, FIN-08200

  • Novartis Investigative Site

    Oulu, Finland, 90100

  • Novartis Investigative Site

    OYS, FIN-90029

  • Novartis Investigative Site

    Pori, Finland, 28120

  • Novartis Investigative Site

    Tampere, 33520

  • Novartis Investigative Site

    Valkeakoski, 37600

Other trials in Finland

Czechia10 sites

  • Novartis Investigative Site

    Brno, 61300

  • Novartis Investigative Site

    Brno-Bohunice, 639 01

  • Novartis Investigative Site

    České Budějovice, Czech Republic, 370 87

  • Novartis Investigative Site

    Ostrava, 702 00

  • Novartis Investigative Site

    Pardubice, 53002

  • Novartis Investigative Site

    Písek, 397 01

  • Novartis Investigative Site

    Prague, Czech Republic, 128 02

  • Novartis Investigative Site

    Prague, 128 08

  • Novartis Investigative Site

    Prague 4 - Krc, 14059

  • Novartis Investigative Site

    Prague 5 - Motol, 15112

Other trials in Czechia

Denmark10 sites

  • Novartis Investigative Site

    Aalborg, DK-9100

  • Novartis Investigative Site

    Aarhus, DK-8000

  • Novartis Investigative Site

    Copenhagen NV, Denmark, DK-2400

  • Novartis Investigative Site

    Frederiksberg, DK-2000

  • Novartis Investigative Site

    Gentofte Municipality, DK-2820

  • Novartis Investigative Site

    Hillerød, DK-3400

  • Novartis Investigative Site

    Hvidovre, 2650

  • Novartis Investigative Site

    Roskilde, Denmark, DK-4000

  • Novartis Investigative Site

    Slagelse, DK-4200

  • Novartis Investigative Site

    Svendborg, DK-5700

Other trials in Denmark

South Africa10 sites

  • Novartis Investigative Site

    Cape Town, 7925

  • Novartis Investigative Site

    Durban, 4001

  • Novartis Investigative Site

    Durban, 4030

  • Novartis Investigative Site

    Durban, 4052

  • Novartis Investigative Site

    Durban, 4110

  • Novartis Investigative Site

    Gauteng

  • Novartis Investigative Site

    Johannesburg, 2196

  • Novartis Investigative Site

    Port Elizabeth, 6001

  • Novartis Investigative Site

    Pretoria, 0002

  • Novartis Investigative Site

    Somerset West, Western Cape, 7130

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Taiwan10 sites

  • Novartis Investigative Site

    Changhua, 500

  • Novartis Investigative Site

    Kaohsiung City, 807

  • Novartis Investigative Site

    Niaosong Township, 83301

  • Novartis Investigative Site

    Taichung, Taiwan, 40705

  • Novartis Investigative Site

    Taichung

  • Novartis Investigative Site

    Taichung County

  • Novartis Investigative Site

    Taipei, Taiwan, 114

  • Novartis Investigative Site

    Taipei, Taiwan

  • Novartis Investigative Site

    Taipei, 10002

  • Novartis Investigative Site

    Yungkang, Tainan, 710

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Austria9 sites

  • Novartis Investigative Site

    Bregenz, A-6900

  • Novartis Investigative Site

    Feldkirch, 6807

  • Novartis Investigative Site

    Graz, 8036

  • Novartis Investigative Site

    Innsbruck, INNSBRUCK

  • Novartis Investigative Site

    Salzburg, A-5020

  • Novartis Investigative Site

    Vienna, Austria, A-1220

  • Novartis Investigative Site

    Vienna, 1030

  • Novartis Investigative Site

    Vienna, 1090

  • Novartis Investigative Site

    Vienna, A-1130

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Sweden8 sites

  • Novartis Investigative Site

    Gothenburg, SE-412 55

  • Novartis Investigative Site

    Helsingborg, 251 87

  • Novartis Investigative Site

    Karlstad, 651 85

  • Novartis Investigative Site

    Malmö, 21152

  • Novartis Investigative Site

    Rättvik, 79530

  • Novartis Investigative Site

    Stenstorp, SE-521 60

  • Novartis Investigative Site

    Uppsala, 751 85

  • Novartis Investigative Site

    Varberg, s-432 81

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Venezuela8 sites

  • Novartis Investigative Site

    Caracas, Distrito Federal, 1010

  • Novartis Investigative Site

    Caracas, Distrito Federal, 1020

  • Novartis Investigative Site

    Caracas, Distrito Federal, 1040

  • Novartis Investigative Site

    Caracas, Distrito Federal, 1080-A

  • Novartis Investigative Site

    Caracas, Distrito Federal, 1100

  • Novartis Investigative Site

    Caracas, Miranda, 1060

  • Novartis Investigative Site

    Puerto Ordaz and San Felix, Bolívar, 8050

  • Novartis Investigative Site

    Valencia, Carabobo, 2001

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Turkey (Türkiye)7 sites

  • Novartis Investigative Site

    Altunizade, 34662

  • Novartis Investigative Site

    Ankara, Turkey, 06590

  • Novartis Investigative Site

    Ankara, 06100

  • Novartis Investigative Site

    Gaziantep, 27070

  • Novartis Investigative Site

    Izmir, 35040

  • Novartis Investigative Site

    Izmir, 35340

  • Novartis Investigative Site

    Kocaeli, 41380

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Peru6 sites

  • Novartis Investigative Site

    Bellavista, Lima region, Callao 02

  • Novartis Investigative Site

    Lima Cercado, Lima region, 01

  • Novartis Investigative Site

    San Borja, Lima region, 41

  • Novartis Investigative Site

    San Isidro, Lima region, 27

  • Novartis Investigative Site

    San Martín de Porres, Lima region, 31

  • Novartis Investigative Site

    Santiago de Surco, Lima region, 33

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Singapore5 sites

  • Novartis Investigative Site

    Singapore, Singapore, 168752

  • Novartis Investigative Site

    Singapore, Singapore, 169608

  • Novartis Investigative Site

    Singapore, Singapore, 308433

  • Novartis Investigative Site

    Singapore, 119074

  • Novartis Investigative Site

    Singapore, 159964

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Colombia4 sites

  • Novartis Investigative Site

    Bogotá

  • Novartis Investigative Site

    Cali

  • Novartis Investigative Site

    Florida Blanca

  • Novartis Investigative Site

    Medellín

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Guatemala4 sites

  • Novartis Investigative Site

    Guatemala City, Departamento de Guatemala, 01001

  • Novartis Investigative Site

    Guatemala City, Departamento de Guatemala, 01010

  • Novartis Investigative Site

    Guatemala City, Departamento de Guatemala, 01011

  • Novartis Investigative Site

    Guatemala City, Departamento de Guatemala, 01015

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Lithuania4 sites

  • Novartis Investigative Site

    Kaunas, 50009

  • Novartis Investigative Site

    Klaipėda, 92304

  • Novartis Investigative Site

    Vilnius, LT-08661

  • Novartis Investigative Site

    Vilnius

Other trials in Lithuania

Thailand4 sites

  • Novartis Investigative Site

    Bangkok, 10330

  • Novartis Investigative Site

    Bangkok, 10400

  • Novartis Investigative Site

    Bangkok, 10700

  • Novartis Investigative Site

    Chiang Mai, 50200

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Puerto Rico2 sites

  • Novartis Investigative Site

    Ponce, 00716

  • Novartis Investigative Site

    Ponce, 00733-1471

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About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Determine Whether, in Patients With Type 2 Diabetes at High Risk for Cardiovascular and Renal Events, Aliskiren, on Top of Conventional Treatment, Reduces Cardiovascular and Renal Morbidity and Mortality

The purpose of this study was to determine whether, in patients with type 2 diabetes and pre-existing disease of the heart and the circulatory system and/or the kidney, aliskiren at a target dose of 300 mg once daily (compared to placebo), on top of conventional treatment, reduces death and disease caused by the heart, the circulatory system and the kidney.

AMENDMENT 4 RATIONALE (MARCH 2012) :

Protocol amendment 4 served to address the data monitoring committee recommendation dated 14 Dec 2011 to discontinue study treatment in all participating patients. It also addressed the subsequent Health Authorities request to implement a 12 month safety follow-up period (actual duration was 9 months in average) post study drug discontinuation.

Being tested
Aliskiren, Placebo
Keywords
Type 2 diabetes mellitus, renal morbidity and mortality, cardiovascular disease, micro-albuminuria, macro-albuminuria, RAAS, renin inhibitor, Reduced estimated glomerular filtration rate
Medical subject headings
Diabetes Mellitus, Type 2, Cardiovascular Diseases

What participants receive

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

  • AliskirenDrug

    Aliskiren 150 mg film-coated tablets

  • PlaceboDrug

    Placebo to match aliskiren 150 mg film-coated tablets

Study groups in NCT00549757
Study groupRoleWhat they receive
AliskirenExperimentalIn Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase. With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment
Receives: Drug: Aliskiren
PlaceboPlacebo comparatorIn Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase. With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
Receives: Drug: Placebo

What is being measured

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

  1. Percentage of Participants With Occurrence of Primary Composite Endpoint (Core : Active Treatment Phase)

    Occurrence was defined as the first event of the following composite primary endpoint:

    • Cardiovascular (CV) death
    • Resuscitated sudden death
    • Non-fatal myocardial infarction (MI)
    • Non-fatal stroke
    • Unplanned hospitalization for heart failure (HF)
    • Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month.
    • Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.

    Measured: Time from randomization to the first event (Maximum 50 months)

  2. Percentage of Participants With Cardiovascular (CV) Death (Core: Active Treatment Phase)

    Measured: Time from randomization to the first event (Maximum 50 months)

  3. Percentage of Participants With Resuscitated Sudden Death (Core: Active Treatment Phase)

    Resuscitated sudden death was adjudicated when a subject experiences sudden death or cardiac arrest and is successfully resuscitated by cardioversion, defibrillation or cardiopulmonary resuscitation with a meaningful recovery of consciousness. This definition excludes known transient losses of consciousness such as seizure or vasovagal episodes that do not reflect significant cardiac dysfunction.

    Measured: Time from randomization to the first event (Maximum 50 Months)

  4. Percentage of Participants With Fatal/Non-fatal Myocardial Infarction (MI) (Core: Active Treatment Phase)

    Measured: Time from randomization to the first event (Maximum 50 Months)

  5. Percentage of Participants With Fatal/Non-fatal Stroke (Core: Active Treatment Phase)

    Measured: Time from randomization to the first event (Maximum 50 Months)

  6. Percentage of Participants With Onset of End-stage Renal Disease (ESRD) (Core: Active Treatment Phase)

    ESRD is defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 µmol per liter) or renal death

    Measured: Time from randomization to the first event (Maximum 50 Months)

  7. Percentage of Participants With Doubling of Baseline Serum Creatinine Concentration, Sustained for at Least One Month (Core: Active Treatment Phase)

    To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.

    Measured: Time from randomization to the first event (Maximum 50 Months)

  8. Percentage of Participants With Unplanned Hospitalization for Heart Failure (Core: Active Treatment Phase)

    Measured: Time from randomization to the first event (Maximum 50 Months)

  9. Percentage of Participants With All Cause Mortality (Core: Active Treatment Phase)

    Measured: Time from randomization to the first event (Maximum 50 months)

  10. Percentage of Participants With Occurrence of Primary Composite Endpoint (Extension Phase)

    Occurrence was defined as the first event of the following composite primary endpoint:

    • Cardiovascular (CV) death
    • Resuscitated sudden death
    • Non-fatal myocardial infarction (MI)
    • Non-fatal stroke
    • Unplanned hospitalization for heart failure (HF)
    • Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month.
    • Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.

    Measured: From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)

  11. Percentage of Participants With Cardiovascular (CV) Death (Extension Phase)

    Measured: from cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)

  12. Percentage of Participants With Resuscitated Sudden Death (Extension Phase)

    Measured: From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)

  13. Percentage of Participants Fatal/Non-fatal Myocardial Infarction (MI) (Extension Phase)

    Measured: From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 month in average)

  14. Percentage of Participants With Fatal/Non-fatal Stroke (Extension Phase)

    Measured: From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)

  15. Percentage of Participants With Onset of End-stage Renal Disease (ESRD) (Extension Phase)

    ESRD is defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 µmol per liter) or renal death

    Measured: From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)

  16. Percentage of Participants Doubling of Baseline Serum Creatinine Concentration, Sustained for at Least One Month (Extension Phase)

    To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.

    Measured: From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)

  17. Percentage of Participants With Unplanned Hospitalization for Heart Failure (Extension Phase)

    Measured: From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)

  18. Percentage of Participants With All Cause Mortality (Extension Phase)

    Measured: from cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)

Secondary outcomes (4)

  1. Percentage of Participants With Occurrence of Secondary Cardiovascular Composite Endpoint (Core: Active Treatment Phase)

    Occurrence was defined as the first event of the following secondary cardiovascular composite endpoint:

    • Cardiovascular (CV) death
    • Resuscitated sudden death
    • Non-fatal myocardial infarction (MI)
    • Non-fatal stroke
    • Unplanned hospitalization for heart failure (HF)

    Measured: Time from randomization to the first event (Maximum 50 months)

  2. Percentage of Participants With Occurrence of Secondary Renal Composite Endpoint (Core: Active Treatment Phase)

    Occurrence was defined as the first event of the following secondary renal composite endpoint:

    • Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month.
    • Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory.The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.

    Measured: Time from randomization to the first event (Maximum 50 months)

  3. Percentage of Participants With Occurrence of Secondary Cardiovascular Composite Endpoint (Extension Phase)

    Occurrence was defined as the first event of the following secondary cardiovascular composite endpoint:

    • Cardiovascular (CV) death
    • Resuscitated sudden death
    • Non-fatal myocardial infarction (MI)
    • Non-fatal stroke
    • Unplanned hospitalization for heart failure (HF)

    Measured: From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)

  4. Percentage of Participants With Occurrence of Secondary Renal Composite Endpoint (Extension Phase)

    Occurrence was defined as the first event of the following secondary renal composite endpoint:

    • Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month.
    • Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.

    Measured: From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)

Timeline

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

  1. First posted26 Oct 2007 (estimated)
  2. Study startOct 2007
  3. Primary completionFeb 2013
  4. Study completionFeb 2013

Why it stopped: Lack of benefit and safety concern

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
8,606 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00549757
Sponsor's protocol ID
CSPP100E2337
Other IDs
2007-000860-25
Acronym
ALTITUDE
Status last verified
Apr 2014
First submitted
24 Oct 2007
Last updated
21 Apr 2014

Publications

  • Jongs N, Gasparyan SB, Frison L, Schloemer P, Brinker M, Little DJ, Heerspink HJL. Use of eGFR Slope Thresholds as End Point Components in a Kidney Disease Progression Hierarchical Composite End Point. J Am Soc Nephrol. 2025 Dec 1;36(12):2421-2430. doi: 10.1681/ASN.0000000766. Epub 2025 Jun 17.

    PubMed 40526444

  • Heerspink HJL, Jongs N, Schloemer P, Little DJ, Brinker M, Tasto C, Karpefors M, Wheeler DC, Bakris G, Perkovic V, Nkulikiyinka R, Rossert J, Gasparyan SB. Development and Validation of a New Hierarchical Composite End Point for Clinical Trials of Kidney Disease Progression. J Am Soc Nephrol. 2023 Dec 1;34(12):2025-2038. doi: 10.1681/ASN.0000000000000243. Epub 2023 Oct 24.

    PubMed 37872654

  • Malachias MVB, Jhund PS, Claggett BL, Wijkman MO, Bentley-Lewis R, Chaturvedi N, Desai AS, Haffner SM, Parving HH, Prescott MF, Solomon SD, De Zeeuw D, McMurray JJV, Pfeffer MA. NT-proBNP by Itself Predicts Death and Cardiovascular Events in High-Risk Patients With Type 2 Diabetes Mellitus. J Am Heart Assoc. 2020 Oct 20;9(19):e017462. doi: 10.1161/JAHA.120.017462. Epub 2020 Sep 23.

    PubMed 32964800

  • Heerspink HJ, Persson F, Brenner BM, Chaturvedi N, Brunel P, McMurray JJ, Desai AS, Solomon SD, Pfeffer MA, Parving HH, de Zeeuw D. Renal outcomes with aliskiren in patients with type 2 diabetes: a prespecified secondary analysis of the ALTITUDE randomised controlled trial. Lancet Diabetes Endocrinol. 2016 Apr;4(4):309-17. doi: 10.1016/S2213-8587(15)00469-6. Epub 2016 Jan 14.

    PubMed 26774608

  • Parving HH, Brenner BM, McMurray JJ, de Zeeuw D, Haffner SM, Solomon SD, Chaturvedi N, Persson F, Desai AS, Nicolaides M, Richard A, Xiang Z, Brunel P, Pfeffer MA; ALTITUDE Investigators. Cardiorenal end points in a trial of aliskiren for type 2 diabetes. N Engl J Med. 2012 Dec 6;367(23):2204-13. doi: 10.1056/NEJMoa1208799. Epub 2012 Nov 3.

    PubMed 23121378

  • Lambers Heerspink HJ, Perkovic V, de Zeeuw D. Renal and cardio-protective effects of direct renin inhibition: a systematic literature review. J Hypertens. 2009 Dec;27(12):2321-31. doi: 10.1097/HJH.0b013e3283310f92.

    PubMed 19727007

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aliskiren in people with Type 2 Diabetes Mellitus and Cardiovascular Disease, run by Novartis Pharmaceuticals at 776 sites in 37 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 5 inclusion and 12 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: stopped early, as of the sponsor's last update on 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 776 sites in United States, Spain, Italy, Germany, China and 32 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?

Yes. Results are posted in the registry (first posted 18 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With Occurrence of Primary Composite Endpoint (Core : Active Treatment Phase) (time frame: Time from randomization to the first event (Maximum 50 months)). The study lists 18 primary outcomes in all. 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 NCT00549757, which also lists 6 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 21 Apr 2014.

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