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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-005012-41 | EudraCT Number |
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This study will assess the effect of vildagliptin on left ventricular function in patients with type 2 diabetes and congestive heart failure (NYHA Class I-III). Effect on HbA1c and overall safety and tolerability will also be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vildagliptin | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vildagliptin | Drug |
| ||
| placebo of vildagliptin |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Benešov | Czech Republic | 25601 | Czechia | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29032139 | Derived | McMurray JJV, Ponikowski P, Bolli GB, Lukashevich V, Kozlovski P, Kothny W, Lewsey JD, Krum H; VIVIDD Trial Committees and Investigators. Effects of Vildagliptin on Ventricular Function in Patients With Type 2 Diabetes Mellitus and Heart Failure: A Randomized Placebo-Controlled Trial. JACC Heart Fail. 2018 Jan;6(1):8-17. doi: 10.1016/j.jchf.2017.08.004. Epub 2017 Oct 11. |
| Label | URL |
|---|---|
| Results for CLAF237A23118 from the Novartis Clinical Trials website | View source |
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|
| 52 weeks |
| Havířov |
| Czech Republic |
| 736 01 |
| Czechia |
| Novartis Investigative Site | Litomyšl | Czech Republic | 570 14 | Czechia |
| Novartis Investigative Site | Prague | Czech Republic | 140 00 | Czechia |
| Novartis Investigative Site | Prague | 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 | Alexandroupoli | 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 | Ahmedabad | Gujarat | 380014 | India |
| Novartis Investigative Site | Vadodara | Gujarat | 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 | New Delhi | National Capital Territory of Delhi | 110070 | 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 | Florence | FI | 50143 | Italy |
| Novartis Investigative Site | Milan | 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 | Preiļi | 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 | Kłodzko | 57-300 | Poland |
| Novartis Investigative Site | Warsaw | 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 | Maramureş | 430071 | Romania |
| Novartis Investigative Site | Brasov | 500173 | Romania |
| Novartis Investigative Site | Kaliningrad | 236016 | Russia |
| Novartis Investigative Site | Kazan' | 420012 | Russia |
| Novartis Investigative Site | Krasnodar | 350072 | Russia |
| Novartis Investigative Site | Moscow | 113093 | Russia |
| Novartis Investigative Site | Moscow | 117997 | Russia |
| Novartis Investigative Site | Moscow | 119048 | Russia |
| Novartis Investigative Site | Moscow | 121552 | Russia |
| Novartis Investigative Site | Moscow | 127473 | Russia |
| Novartis Investigative Site | Moscow | 129110 | Russia |
| Novartis Investigative Site | N.Novgorod | 603126 | Russia |
| Novartis Investigative Site | Nizhny Novgorod | 603018 | Russia |
| Novartis Investigative Site | Penza | 440026 | Russia |
| Novartis Investigative Site | Petrozavodsk | 185019 | Russia |
| Novartis Investigative Site | Saint Petersburg | 193312 | Russia |
| Novartis Investigative Site | Saint Petersburg | 197341 | Russia |
| Novartis Investigative Site | Saint Petersburg | 198013 | Russia |
| Novartis Investigative Site | Saint Petersburg | 199034 | Russia |
| Novartis Investigative Site | Samara | 443067 | Russia |
| Novartis Investigative Site | Saratov | 410012 | Russia |
| Novartis Investigative Site | Saratov | 410031 | Russia |
| Novartis Investigative Site | Singapore | 119074 | Singapore |
| Novartis Investigative Site | Singapore | 168752 | Singapore |
| Novartis Investigative Site | Dunajská Streda | Slovak Republic | 929 01 | Slovakia |
| Novartis Investigative Site | Nitra | Slovak Republic | 949 01 | Slovakia |
| Novartis Investigative Site | Banská Bystrica | 974 01 | Slovakia |
| Novartis Investigative Site | Komárno | 945 01 | Slovakia |
| Novartis Investigative Site | Košice | 040 01 | Slovakia |
| Novartis Investigative Site | Lučenec | 98439 | Slovakia |
| Novartis Investigative Site | Modava Nad Bodvou | 045 01 | Slovakia |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D003924 | Diabetes Mellitus, Type 2 |
| D008659 | Metabolic Diseases |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077597 | Vildagliptin |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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