Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints (Core and Extension Phases)
Launched by NOVARTIS PHARMACEUTICALS · Oct 25, 2007
Trial Information
Current as of May 02, 2025
Terminated
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- * 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.
- Exclusion Criteria:
- • 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
- • 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)
- EXCLUSION SPECIFIC TO THE SAFETY FOLLOW-UP PERIOD:
- • - Aliskiren or aliskiren containing fixed combination products must not be used
- • Other protocol-defined inclusion/exclusion criteria applied
About Novartis Pharmaceuticals
Novartis Pharmaceuticals is a global healthcare company dedicated to reimagining medicine to improve and extend people's lives. With a strong focus on innovation, Novartis engages in the research, development, and commercialization of a broad range of therapies across various therapeutic areas, including oncology, cardiology, dermatology, and neuroscience. The company is committed to advancing scientific knowledge and patient care through clinical trials that prioritize safety and efficacy. Novartis leverages cutting-edge technology and collaborative partnerships to address unmet medical needs and deliver transformative treatments that enhance patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Zwolle, , Netherlands
Boca Raton, Florida, United States
Hannover, , Germany
Bern, , Switzerland
Fullerton, California, United States
Hollywood, Florida, United States
West Palm Beach, Florida, United States
Louisville, Kentucky, United States
Metairie, Louisiana, United States
Amarillo, Texas, United States
Montreal, Quebec, Canada
Szeged, , Hungary
Delft, , Netherlands
Doetinchem, , Netherlands
Eindhoven, , Netherlands
Heerlen, , Netherlands
Nieuwegein, , Netherlands
Port Elizabeth, , South Africa
Madrid, , Spain
Ankara, , Turkey
Barcelona, , Spain
Leuven, , Belgium
Limoges Cedex, , France
Lyon, , France
Mainz, , Germany
Bergamo, Bg, Italy
Bologna, Bo, Italy
Genova, Ge, Italy
Monza, Mb, Italy
Pavia, Pv, Italy
Napoli, , Italy
Taegu, , Korea, Republic Of
Niaosong Township, , Taiwan
Atlanta, Georgia, United States
Charleston, South Carolina, United States
Houston, Texas, United States
Bruxelles, , Belgium
Porto Alegre, Rs, Brazil
Heidelberg, , Germany
Perugia, Pg, Italy
Pisa, Pi, Italy
Parma, Pr, Italy
Siena, Si, Italy
Sassari, Ss, Italy
Hospitalet De Llobregat, Barcelona, Spain
Zuerich, , Switzerland
Taichung, , Taiwan
Taipei, , Taiwan
Graz, , Austria
Edegem, , Belgium
Lausanne, , Switzerland
Bonheiden, , Belgium
Brugge, , Belgium
Gent, , Belgium
Liege, , Belgium
Turnhout, , Belgium
Hillerød, , Denmark
Roskilde, , Denmark
Chieti, Ch, Italy
Udine, Ud, Italy
Verona, Vr, Italy
Malaga, Andalucia, Spain
Sabadell, Barcelona, Spain
Ann Arbor, Michigan, United States
Albuquerque, New Mexico, United States
Salzburg, , Austria
Detroit, Michigan, United States
Seoul, Korea, Korea, Republic Of
Wuhan, Hubei, China
Montgomery, Alabama, United States
Honolulu, Hawaii, United States
Wien, , Austria
London, Ontario, Canada
Uppsala, , Sweden
St. Gallen, , Switzerland
Cardiff, , United Kingdom
Fayetteville, Arkansas, United States
Springfield, Missouri, United States
Tulsa, Oklahoma, United States
Austin, Texas, United States
San Antonio, Texas, United States
Charleroi, , Belgium
Greenfield Park, Quebec, Canada
Dalian, Liaoning, China
Groningen, , Netherlands
Porto, , Portugal
Singapore, , Singapore
Kaohsiung, , Taiwan
Bangkok, , Thailand
Chiang Mai, , Thailand
Mobile, Alabama, United States
Rotterdam, , Netherlands
Minneapolis, Minnesota, United States
Greenville, South Carolina, United States
Cali, , Colombia
Bennington, Vermont, United States
Topeka, Kansas, United States
Innsbruck, , Austria
Grenoble, , France
Torino, To, Italy
Bonn, , Germany
Cona, Fe, Italy
Oakland, California, United States
New Delhi, , India
Pretoria, , South Africa
Izmir, , Turkey
Torrance, California, United States
Peoria, Arizona, United States
Lansdale, Pennsylvania, United States
Firenze, Fi, Italy
Cape Town, , South Africa
Granada, Andalucia, Spain
Valencia, Comunidad Valenciana, Spain
Santiago De Compostela, Galicia, Spain
Caracas, Distrito Capital, Venezuela
Burlingame, California, United States
Livonia, Michigan, United States
Omaha, Nebraska, United States
Oklahoma City, Oklahoma, United States
Lancaster, Pennsylvania, United States
Warwick, Rhode Island, United States
Renton, Washington, United States
Genk, , Belgium
Hasselt, , Belgium
Kortrijk, , Belgium
Roeselare, , Belgium
Arnhem, , Netherlands
Besancon Cedex, , France
Hyderabad, , India
Ahmedabad, , India
Bangalore, , India
Mangalore, , India
Birmingham, Alabama, United States
Huntsville, Alabama, United States
Muscle Shoals, Alabama, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Huntington Beach, California, United States
Pasadena, California, United States
Riverside, California, United States
Spring Valley, California, United States
Walnut Creek, California, United States
Denver, Colorado, United States
Bridgeport, Connecticut, United States
Aventura, Florida, United States
Ft. Lauderdale, Florida, United States
Jacksonville, Florida, United States
Lauderdale Lakes, Florida, United States
Pensacola, Florida, United States
Plantation, Florida, United States
Augusta, Georgia, United States
Cumming, Georgia, United States
Champaign, Illinois, United States
Lake Zurich, Illinois, United States
Slidell, Louisiana, United States
Baltimore, Maryland, United States
Burlington, Massachusetts, United States
Haverhill, Massachusetts, United States
Jamaica Plain, Massachusetts, United States
Natick, Massachusetts, United States
North Dartmouth, Massachusetts, United States
Waltham, Massachusetts, United States
Worcester, Massachusetts, United States
Kalamazoo, Michigan, United States
St. Louis Park, Minnesota, United States
Belzoni, Mississippi, United States
Gulfport, Mississippi, United States
Jackson, Mississippi, United States
St. Louis, Missouri, United States
Fremont, Nebraska, United States
Dover, New Hampshire, United States
Princeton Junction, New Jersey, United States
Albany, New York, United States
Rochester, New York, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Lyndhurst, Ohio, United States
Norman, Oklahoma, United States
Allentown, Pennsylvania, United States
Melrose Park, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Wyomissing, Pennsylvania, United States
Aiken, South Carolina, United States
Columbia, South Carolina, United States
Orangeburg, South Carolina, United States
Collierville, Tennessee, United States
Dallas, Texas, United States
Irving, Texas, United States
Mcallen, Texas, United States
North Richland Hills, Texas, United States
Plano, Texas, United States
Temple, Texas, United States
Alexandria, Virginia, United States
Burke, Virginia, United States
Appleton, Wisconsin, United States
Caba, Buenos Aires, Argentina
Florida, Buenos Aires, Argentina
Lanus, Buenos Aires, Argentina
Ramos Mejia, Buenos Aires, Argentina
Zarate, Buenos Aires, Argentina
Rosario, Santa Fe, Argentina
Buenos Aires, , Argentina
Cordoba, , Argentina
Corrientes, , Argentina
Santa Fe, , Argentina
Bregenz, , Austria
Feldkirch, , Austria
Vienna, , Austria
Brussel, , Belgium
De Pinte, , Belgium
La Louvière, , Belgium
Ronse, , Belgium
Seraing, , Belgium
Sint Gillis Waas, , Belgium
Vilvoorde, , Belgium
Willebroek, , Belgium
Salvador, Ba, Brazil
Fortaleza, Ce, Brazil
Vitoria, Es, Brazil
Juiz De Fora, Mg, Brazil
Belem, Pa, Brazil
Rio De Janeiro, Rj, Brazil
Campinas, Sp, Brazil
Marilia, Sp, Brazil
Santos, Sp, Brazil
Sao Jose Do Rio Preto, Sp, Brazil
Sorocaba, Sp, Brazil
São Paulo, Sp, Brazil
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Winnipeg, Manitoba, Canada
Bay Roberts, Newfoundland And Labrador, Canada
St. John's, Newfoundland And Labrador, Canada
Brampton, Ontario, Canada
Burlington, Ontario, Canada
Cambridge, Ontario, Canada
Courtice, Ontario, Canada
Etobicoke, Ontario, Canada
North Bay, Ontario, Canada
Oakville, Ontario, Canada
Oshawa, Ontario, Canada
Ottawa, Ontario, Canada
Scarborough, Ontario, Canada
Thornhill, Ontario, Canada
Toronto, Ontario, Canada
Mirabel, Quebec, Canada
Pointe Claire, Quebec, Canada
Québec, Quebec, Canada
Sainte Foy, Quebec, Canada
Sherbrooke, Quebec, Canada
Ste Foy, Quebec, Canada
Trois Rivières, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Ouest Montreal, , Canada
Beijing, Beijing, China
Chongqing, Chongqing, China
Fuzhou, Fujian, China
Guangzhou, Guangdong, China
Shijiazhuang, Hebei, China
Harbin, Heilongjiang, China
Changsha City, Hunan, China
Changsha, Hunan, China
Nanjing, Jiangsu, China
Suzhou, Jiangsu, China
Shenyang, Liaoning, China
Qingdao, Shandong, China
Xi'an, Shanxi, China
Chengdu, Sichuan, China
Kunming, Yunnan, China
Hangzhou, Zhejiang, China
Shanghai, , China
Tianjin, , China
Bogotá, , Colombia
Florida Blanca, , Colombia
Medellín, , Colombia
Brno Bohunice, , Czech Republic
Brno, , Czech Republic
Ceske Budejovice, , Czech Republic
Ostrava, , Czech Republic
Pardubice, , Czech Republic
Pisek, , Czech Republic
Prague 2, , Czech Republic
Prague 4 Krc, , Czech Republic
Prague 5 Motol, , Czech Republic
Aalborg, , Denmark
Copenhagen Nv, , Denmark
Frederiksberg, , Denmark
Gentofte, , Denmark
Hvidovre, , Denmark
Slagelse, , Denmark
Svendborg, , Denmark
århus, , Denmark
Helsinki, , Finland
Hyvinkää, , Finland
Kajaani, , Finland
Kuopio, , Finland
Lohja, , Finland
Oulu, , Finland
Oys, , Finland
Pori, , Finland
Tammisaari, , Finland
Tampere, , Finland
Valkeakoski, , Finland
Bondy, , France
Corbeil Essonnes, , France
La Rochelle, , France
Lagny Sur Marne, , France
Lyon Cedex 03, , France
Paris Cedex 18, , France
Paris Cedex 4, , France
Poitiers Cedex, , France
Aschaffenburg, , Germany
Asslar, , Germany
Bad Oeynhausen, , Germany
Barsinghausen, , Germany
Bensheim, , Germany
Berlin, , Germany
Bottrop, , Germany
Bremen, , Germany
Bretten, , Germany
Cloppenburg, , Germany
Dippoldiswalde, , Germany
Dresden, , Germany
Duesseldorf, , Germany
Essen, , Germany
Fuldatal, , Germany
Göttingen, , Germany
Hagen, , Germany
Hamburg, , Germany
Heilbronn, , Germany
Ingelheim, , Germany
Jena, , Germany
Kassel, , Germany
Krefeld, , Germany
Magdeburg, , Germany
Messkirch, , Germany
Muehldorf Am Inn, , Germany
Neuwied, , Germany
Offenbach, , Germany
Rehburg Loccum, , Germany
Riesa, , Germany
Schauenburg Elgershausen, , Germany
Schwabenheim, , Germany
St. Ingbert Oberwuerzbach, , Germany
Ursensollen, , Germany
Wetter, , Germany
Wiehl, , Germany
Wiesbaden, , Germany
Wuerzburg, , Germany
Alexandroupolis, , Greece
Athens Gr, , Greece
Athens, , Greece
Ioannina, , Greece
Patras, , Greece
Piraeurs, , Greece
Thessaloniki, , Greece
Guatemala City, , Guatemala
Baja, , Hungary
Balatonfured, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Gyula, , Hungary
Kaposvar, , Hungary
Miskolc, , Hungary
Pecs, , Hungary
Zalaegerszeg, , Hungary
Banglaore, Karnataka, India
Kochi, Kerala, India
Mumbai, Maharashtra, India
Pune, Maharashtra, India
Chennai, Tamil Nadu, India
Vellore, Tamil Nadu, India
Kolkota, , India
L'aquila, Aq, Italy
Belluno, Bl, Italy
Campobasso, Cb, Italy
Caserta, Ce, Italy
Cuneo, Cn, Italy
Cosenza, Cs, Italy
Catanzaro, Cz, Italy
Foggia, Fg, Italy
Arenzano, Ge, Italy
Pozzilli, Is, Italy
Lecco, Lc, Italy
Milano, Mi, Italy
Passirana Di Rho, Mi, Italy
Palermo, Pa, Italy
Pordenone, Pn, Italy
Casorate Primo, Pv, Italy
Stradella, Pv, Italy
Ravenna, Ra, Italy
Roma, Rm, Italy
Cava De' Tirreni, Sa, Italy
Mercato San Severino, Sa, Italy
Salerno, Sa, Italy
Olbia, Ss, Italy
Vittorio Veneto, Tv, Italy
San Daniele Del Friuli, Ud, Italy
Venezia, Ve, Italy
Isernia, , Italy
Nagoya, Aichi, Japan
Asahi, Chiba, Japan
Kasuga, Fukuoka, Japan
Kitakyushu, Fukuoka, Japan
Koriyama City, Fukushima, Japan
Asahikawa, Hokkaido, Japan
Sapporo City, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Toride City, Ibaraki, Japan
Takamatsu, Kagawa, Japan
Aira City, Kagoshima, Japan
Isehara City, Kanagawa, Japan
Kawasaki, Kanagawa, Japan
Yatsushiro, Kumamoto, Japan
Kyoto City, Kyoto, Japan
Sendai City, Miyagi, Japan
Suwa, Nagano, Japan
Okayama City, Okayama, Japan
Takatsuki City, Osaka, Japan
Toyonaka, Osaka, Japan
Yao City, Osaka, Japan
Tokorozawa, Saitama, Japan
Ohtsu City, Shiga, Japan
Shimizu, Shizuoka, Japan
Bunkyo Ku, Tokyo, Japan
Chuo Ku, Tokyo, Japan
Takaoka, Toyama, Japan
Oita, , Japan
Okayama, , Japan
Ansan, Gyeonggi Do, Korea, Republic Of
Anyang, Gyeonggi Do, Korea, Republic Of
Bundang, Seongnam, Korea, Republic Of
Busan, , Korea, Republic Of
Daejeon, , Korea, Republic Of
Incheon, , Korea, Republic Of
Pusan, , Korea, Republic Of
Kaunas, , Lithuania
Klaipeda, , Lithuania
Vilnius, , Lithuania
Alkmaar, , Netherlands
Almelo, , Netherlands
Amersfoort, , Netherlands
Amsterdam, , Netherlands
Apeldoorn, , Netherlands
Breda, , Netherlands
Den Helder, , Netherlands
Deventer, , Netherlands
Dordrecht, , Netherlands
Goes, , Netherlands
Hoogeveen, , Netherlands
Hoogwoud, , Netherlands
Losser, , Netherlands
Meppel, , Netherlands
Oude Pekela, , Netherlands
Tiel, , Netherlands
Utrecht, , Netherlands
Venlo, , Netherlands
Woerden, , Netherlands
Zwijndrecht, , Netherlands
Bergen, , Norway
Fredrikstad, , Norway
Horten, , Norway
Hønefoss, , Norway
Oslo, , Norway
Skedsmokorset, , Norway
Skien, , Norway
Spikkestad, , Norway
Stavanger, , Norway
Svelvik, , Norway
Tromsø, , Norway
Trondheim, , Norway
Tønsberg, , Norway
Bellavista, Lima, Peru
Cercado De Lima, Lima, Peru
San Borja, Lima, Peru
San Isidro, Lima, Peru
San Martin De Porres, Lima, Peru
Santiago De Surco, Lima, Peru
Almada, , Portugal
Amadora, , Portugal
Coimbra, , Portugal
Linda A Velha, , Portugal
Lisboa, , Portugal
Matosinhos, , Portugal
Portimão, , Portugal
Santa Maria Da Feira, , Portugal
Santarém, , Portugal
Ponce, , Puerto Rico
Bratislava, Slovak Republic, Slovakia
Kosice, Slovak Republic, Slovakia
Zilina, Slovak Republic, Slovakia
Banksa Bystrica, , Slovakia
Lubochna, , Slovakia
Lucenec, , Slovakia
Martin, , Slovakia
Nitra, , Slovakia
Piestany, , Slovakia
Prievidza, , Slovakia
Trstena, , Slovakia
Somerset West, Western Cape, South Africa
Durban, , South Africa
Gauteng, , South Africa
Johannesburg, , South Africa
Cadiz, Andalucia, Spain
Jerez De La Frontera, Andalucia, Spain
Málaga, Andalucia, Spain
Puerto De Santa Maria, Andalucia, Spain
Sanlúcar De Barrameda, Andalucia, Spain
Sevilla, Andalucia, Spain
Oviedo, Asturias, Spain
Alcazar De San Juan, Castilla La Mancha, Spain
Aranda De Duero, Castilla Y Leon, Spain
Miranda De Ebro, Castilla Y Leon, Spain
Girona, Cataluña, Spain
La Pobla Llarga, Cataluña, Spain
Llança, Cataluña, Spain
Manresa, Cataluña, Spain
Mollet Del Vallés, Cataluña, Spain
Rubi, Cataluña, Spain
Santa Coloma De Gramanet, Cataluña, Spain
Tarrega, Cataluña, Spain
Vic, Cataluña, Spain
Alacuas, Comunidad Valenciana, Spain
Alicante, Comunidad Valenciana, Spain
Alzira, Comunidad Valenciana, Spain
Benidorm, Comunidad Valenciana, Spain
Puerto De Sagunto, Comunidad Valenciana, Spain
Quart De Poblet, Comunidad Valenciana, Spain
Xixona, Comunidad Valenciana, Spain
Mérida, Extremadura, Spain
Begonte, Galicia, Spain
Ferrol, Galicia, Spain
La Coruña, Galicia, Spain
Pontevedra, Galicia, Spain
Vigo, Galicia, Spain
Palma De Mallorca, Islas Baleares, Spain
Alcorcón, Madrid, Spain
Arganda Del Rey, Madrid, Spain
Civdad Real, Madrid, Spain
Murcia, Madrid, Spain
Plentzia, Pais Vasco, Spain
San Sebastian, Pais Vasco, Spain
Villabona, Pais Vasco, Spain
Zumarraga, Pais Vasco, Spain
Alfaro, Rioja, Spain
Logroño, Rioja, Spain
Hospitalet De Llbregat, , Spain
Göteborg, , Sweden
Helsingborg, , Sweden
Karlstad, , Sweden
Malmö, , Sweden
Rättvik, , Sweden
Stenstorp, , Sweden
Varberg, , Sweden
Estavayer Le Lac, Ch, Switzerland
Ascona, , Switzerland
Bolligen, , Switzerland
Bruderholz, , Switzerland
Fribourg, , Switzerland
La Chaux De Fonds, , Switzerland
Lugano, , Switzerland
Renens, , Switzerland
Schaffhausen, , Switzerland
Winterthur, , Switzerland
Yungkang, Tainan, Taiwan
Changhua, , Taiwan
Taichung County, , Taiwan
Altunizade, , Turkey
Gaziantep, , Turkey
Kocaeli, , Turkey
High Wycombe, Buckinghamshire, United Kingdom
Truro, Cornwall, United Kingdom
Paignton, Devon, United Kingdom
Cornwall, England, United Kingdom
Welwyn Garden City,, Hertfordshire, United Kingdom
Gravesend, Kent, United Kingdom
Glasgow, Scotland, United Kingdom
East Horsley, Surrey, United Kingdom
Crawley, West Sussex, United Kingdom
Bath, , United Kingdom
Irvine, , United Kingdom
Lancashire, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Merseyside, , United Kingdom
Rugby, , United Kingdom
Vale Of Glanmorgan, , United Kingdom
Wrexham, , United Kingdom
Puerto Ordaz, Estado Bolívar, Venezuela
Valencia, Estado Carabobo, Venezuela
Patients applied
Trial Officials
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
Novartis
Study Chair
Novartis
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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