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Clinical Trial Details

Trial ID: L3659
Source ID: NCT00894868
Associated Drug: Vildagliptin
Title: Effect of Vildagliptin on Left Ventricular Function in Patients With Type 2 Diabetes and Congestive Heart Failure
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Congestive Heart Failure|Type II Diabetes Mellitus
Interventions: DRUG: vildagliptin|DRUG: placebo of vildagliptin
Outcome Measures: Primary: To evaluate the effect of vildagliptin on left ventricular function in patients with T2DM and CHF (NYHA class I-III) by showing that vildagliptin is at least not inferior to placebo with respect to change in left ventricular ejection fraction (LVEF)., 52 weeks | Secondary: To evaluate the overall safety of vildagliptin versus placebo in patients with T2DM and CHF (NYHA class I - III) over 52 weeks of treatment with special regard to signs and symptoms of heart failure., 52 weeks|To evaluate the efficacy of vildagliptin in patients with T2DM and CHF (NYHA class I-III) by assessing the HbA1c reduction with vildagliptin compared to placebo after 16 weeks of treatment., 52 weeks
Sponsor/Collaborators: Sponsor: Novartis Pharmaceuticals
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 798
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2009-05
Completion Date: 2012-08
Results First Posted:
Last Update Posted: 2020-12-17
Locations: Novartis Investigative Site, Benesov, Czech Republic, 25601, Czechia|Novartis Investigative Site, Havirov, Czech Republic, 736 01, Czechia|Novartis Investigative Site, Litomysl, Czech Republic, 570 14, Czechia|Novartis Investigative Site, Praha 4, Czech Republic, 140 00, Czechia|Novartis Investigative Site, Praha 2, CZE, 128 08, Czechia|Novartis Investigative Site, Broumov, 550 01, Czechia|Novartis Investigative Site, Pardubice, 53002, Czechia|Novartis Investigative Site, Copenhagen NV, DK-2400, Denmark|Novartis Investigative Site, Copenhagen S, DK-2300, Denmark|Novartis Investigative Site, Frederiksberg, DK-2000, Denmark|Novartis Investigative Site, Hellerup, DK-2900, Denmark|Novartis Investigative Site, Roskilde, DK-4000, Denmark|Novartis Investigative Site, Slagelse, DK-4200, Denmark|Novartis Investigative Site, Pärnu, 80018, Estonia|Novartis Investigative Site, Tallinn, 10138, Estonia|Novartis Investigative Site, Tallinn, 13415, Estonia|Novartis Investigative Site, Tartu, 50410, Estonia|Novartis Investigative Site, Alsdorf, 52477, Germany|Novartis Investigative Site, Bad Oeynhausen, 32545, Germany|Novartis Investigative Site, Dresden, 01307, Germany|Novartis Investigative Site, Fulda, 36037, Germany|Novartis Investigative Site, Kamp-Lintfort, 47475, Germany|Novartis Investigative Site, Saarlouis, 66740, Germany|Novartis Investigative Site, Senden, 48308, Germany|Novartis Investigative Site, Alexandroupolis, GR 68100, Greece|Novartis Investigative Site, Chios, 82100, Greece|Novartis Investigative Site, Thessaloniki, 57001, Greece|Novartis Investigative Site, Guatemala City, 01010, Guatemala|Novartis Investigative Site, Guatemala City, 01011, Guatemala|Novartis Investigative Site, Secunderabad, Andhra Pradesh, 500003, India|Novartis Investigative Site, Visakhapatnam, Andhra Pradesh, 530002, India|Novartis Investigative Site, Vishakhapatnam, Andhra Pradesh, 530002, India|Novartis Investigative Site, New Delhi, Delhi, 110070, India|Novartis Investigative Site, Ahmedabad, Gujarat, 380014, India|Novartis Investigative Site, Vadodara, Gujrat, 390015, India|Novartis Investigative Site, Bangalore, Karnataka, 560078, India|Novartis Investigative Site, Mangalore, Karnataka, 575002, India|Novartis Investigative Site, Trivandrum, Kerala, 695011, India|Novartis Investigative Site, Indore, Madhya Pradesh, 452010, India|Novartis Investigative Site, Nagpur, Maharashtra, 440012, India|Novartis Investigative Site, Ludhiana, Punjab, 141001, India|Novartis Investigative Site, Jaipur, Rajasthan, 302001, India|Novartis Investigative Site, Lucknow, Uttar Pradesh, 226003, India|Novartis Investigative Site, Bergamo, BG, 24128, Italy|Novartis Investigative Site, Firenze, FI, 50143, Italy|Novartis Investigative Site, Milano, MI, 20132, Italy|Novartis Investigative Site, Passirana Di Rho, MI, 20017, Italy|Novartis Investigative Site, Pavia, PV, 27100, Italy|Novartis Investigative Site, Mercato San Severino, SA, 84085, Italy|Novartis Investigative Site, Siena, SI, 53100, Italy|Novartis Investigative Site, Novara, 28100, Italy|Novartis Investigative Site, Daugavpils, LV-5401, Latvia|Novartis Investigative Site, Preili, LV-5301, Latvia|Novartis Investigative Site, Alytus, LT-62381, Lithuania|Novartis Investigative Site, Kaunas, 50009, Lithuania|Novartis Investigative Site, Vilnius, LT-05261, Lithuania|Novartis Investigative Site, Vilnius, LT-08661, Lithuania|Novartis Investigative Site, Gdansk, 80-847, Poland|Novartis Investigative Site, Klodzko, 57-300, Poland|Novartis Investigative Site, Warsawa, 04-761, Poland|Novartis Investigative Site, Wroclaw, 50-981, Poland|Novartis Investigative Site, Bucharest, District 2, 021382, Romania|Novartis Investigative Site, Craiova, Jud. Dolj, 200147, Romania|Novartis Investigative Site, Baia-Mare, Maramures, 430071, Romania|Novartis Investigative Site, Brasov, 500173, Romania|Novartis Investigative Site, Kaliningrad, 236016, Russian Federation|Novartis Investigative Site, Kazan, 420012, Russian Federation|Novartis Investigative Site, Krasnodar, 350072, Russian Federation|Novartis Investigative Site, Moscow, 113093, Russian Federation|Novartis Investigative Site, Moscow, 117997, Russian Federation|Novartis Investigative Site, Moscow, 119048, Russian Federation|Novartis Investigative Site, Moscow, 121552, Russian Federation|Novartis Investigative Site, Moscow, 127473, Russian Federation|Novartis Investigative Site, Moscow, 129110, Russian Federation|Novartis Investigative Site, N.Novgorod, 603126, Russian Federation|Novartis Investigative Site, Nizhny Novgorod, 603018, Russian Federation|Novartis Investigative Site, Penza, 440026, Russian Federation|Novartis Investigative Site, Petrozavodsk, 185019, Russian Federation|Novartis Investigative Site, Saint-Petersburg, 193312, Russian Federation|Novartis Investigative Site, Saint-Petersburg, 197341, Russian Federation|Novartis Investigative Site, Samara, 443067, Russian Federation|Novartis Investigative Site, Saratov, 410012, Russian Federation|Novartis Investigative Site, Saratov, 410031, Russian Federation|Novartis Investigative Site, St. Petersburg, 198013, Russian Federation|Novartis Investigative Site, St.- Petersburg, 199034, Russian Federation|Novartis Investigative Site, Singapore, 119074, Singapore|Novartis Investigative Site, Singapore, 168752, Singapore|Novartis Investigative Site, Dunajska Streda, Slovak Republic, 929 01, Slovakia|Novartis Investigative Site, Nitra, Slovak Republic, 949 01, Slovakia|Novartis Investigative Site, Banska Bystrica, 974 01, Slovakia|Novartis Investigative Site, Komarno, 945 01, Slovakia|Novartis Investigative Site, Kosice, 040 01, Slovakia|Novartis Investigative Site, Lucenec, 98439, Slovakia|Novartis Investigative Site, Modava Nad Bodvou, 045 01, Slovakia
URL: https://clinicaltrials.gov/show/NCT00894868

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D432 Vildagliptin small molecule DB04876 Details