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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT No 2004-02550-56 |
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The development program has been terminated
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This is a 24-week study to determine the lipid metabolic effects, safety, and tolerability of tesaglitazar compared with metformin and metformin in combination with fenofibrate in patients with type 2 diabetes and low high-density lipoprotein cholesterol (HDL-C). Improvement in dyslipidemia will be evaluated. The study comprises a 2-week enrollment period, 6-week run-in and a 24-week randomized, double blind, parallel group, multi-center, active controlled (metformin with or without fenofibrate) treatment period and a 3-week follow-up. From visit 2 (run-in), all patients will receive a standardized dose of statin (rosuvastatin)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tesaglitazar | Drug | |||
| Metformin | Drug | |||
| Fenofibrate | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The change in HDL-C from baseline to the end of the randomized treatment period. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the following variables from baseline to the end of the randomized treatment period: | ||
| Lipid and lipoprotein variables (triglycerides [TG], non-HDL-C, total cholesterol, low-density lipoprotein cholesterol [LDL-C], lipoprotein particle size and concentration, free fatty acid, apolipoprotein [Apo] AI, Apo B, Apo CIII) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca Galida Medical Science DIrector, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Fortaleza | Ceará | Brazil | |||
| Research Site |
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| Responder analyses for HDL-C, TG, and non-HDL-C according to pre-specified values |
| The proportion of patients reaching pre-specified target levels for HDL-C, TG, and non-HDL-C |
| Risk markers for cardiovascular disease (C-reactive protein, insulin, homeostasis model assessment, LDL-C/HDL-C ratio, very-low-density lipoprotein cholesterol/LDL-C ratio, Apo B/Apo AI ratio) |
| Central obesity (waist/hip ratio) |
| Pharmacokinetics of tesaglitazar |
| Safety and tolerability of tesaglitazar by assessment of adverse events, laboratory values, electrocardiogram, pulse, blood pressure, hypoglycemic events, body weight, cardiac evaluation, and physical examination |
| Goiânia |
| Goiás |
| Brazil |
| Research Site | Porto Alegre | Rio Grande do Sul | Brazil |
| Research Site | São Paulo | São Paulo | Brazil |
| Research Site | Curitiba | Brazil |
| Research Site | Calgary | Alberta | Canada |
| Research Site | Surrey | British Columbia | Canada |
| Research Site | Bay Roberts | Newfoundland and Labrador | Canada |
| Research Site | Mount Pearl | Newfoundland and Labrador | Canada |
| Research Site | St. John's | Newfoundland and Labrador | Canada |
| Research Site | Bolton | Ontario | Canada |
| Research Site | Brampton | Ontario | Canada |
| Research Site | Etobicoke | Ontario | Canada |
| Research Site | Hastings | Ontario | Canada |
| Research Site | Kingston | Ontario | Canada |
| Research Site | Kitchener | Ontario | Canada |
| Research Site | London | Ontario | Canada |
| Research Site | Mississauga | Ontario | Canada |
| Research Site | Napanee | Ontario | Canada |
| Research Site | Newboro | Ontario | Canada |
| Research Site | Ottawa | Ontario | Canada |
| Research Site | Montreal | Quebec | Canada |
| Research Site | Pointe-Claire | Quebec | Canada |
| Research Site | Sherbrooke | Quebec | Canada |
| Research Site | Helsinki | Finland |
| Research Site | Kuopio | Finland |
| Research Site | Lahti | Finland |
| Research Site | Mikkeli | Finland |
| Research Site | Oulu | Finland |
| Research Site | Porvoo | Finland |
| Research Site | Savonlinna | Finland |
| Research Site | Seinäjoki | Finland |
| Research Site | Suonenjoki | Finland |
| Research Site | Tampere | Finland |
| Research Site | Turku | Finland |
| Research Site | Vaasa | Finland |
| Research Site | Aix-en-Provence | France |
| Research Site | Ambriere LES Vallees | France |
| Research Site | Béziers | France |
| Research Site | Briey | France |
| Research Site | Broglie | France |
| Research Site | Château-Gontier | France |
| Research Site | Cremeaux | France |
| Research Site | Falaise | France |
| Research Site | Fontaine Saint Martin | France |
| Research Site | Freyming-Merlebach | France |
| Research Site | Gan | France |
| Research Site | Hyères | France |
| Research Site | Jarny | France |
| Research Site | Jort | France |
| Research Site | L'Aigle | France |
| Research Site | Lambersart | France |
| Research Site | Le Lavandou | France |
| Research Site | Lille | France |
| Research Site | Lomme | France |
| Research Site | Marange-Silvange | France |
| Research Site | Marignane | France |
| Research Site | Mars-la-Tour | France |
| Research Site | Martigues | France |
| Research Site | Mayenne | France |
| Research Site | Metz | France |
| Research Site | Mondelange | France |
| Research Site | Montbrison | France |
| Research Site | Montpellier | France |
| Research Site | Moûtiers | France |
| Research Site | Nantes | France |
| Research Site | Paris | France |
| Research Site | Poitiers | France |
| Research Site | Roanne | France |
| Research Site | Roquevaire | France |
| Research Site | Rugles | France |
| Research Site | Saint-Chamond | France |
| Research Site | Saint-Jean-de-Luz | France |
| Research Site | Tantonville | France |
| Research Site | Heidelberg | Baden-Wurttemberg | Germany |
| Research Site | Stuttgart | Baden-Wurttemberg | Germany |
| Research Site | München | Bavaria | Germany |
| Research Site | Frankfurt am Main | Hesse | Germany |
| Research Site | Hanover | Lower Saxony | Germany |
| Research Site | Düsseldorf | North Rhine-Westphalia | Germany |
| Research Site | Münster | North Rhine-Westphalia | Germany |
| Research Site | Dresden | Saxony | Germany |
| Research Site | Berlin | State of Berlin | Germany |
| Research Site | Aschaffenburg | Germany |
| Research Site | Beckum | Germany |
| Research Site | Berlin | Germany |
| Research Site | Dresden | Germany |
| Research Site | Düsseldorf | Germany |
| Research Site | Essen | Germany |
| Research Site | Gelnhausen | Germany |
| Research Site | Hanover | Germany |
| Research Site | Heidelberg | Germany |
| Research Site | Heilbronn | Germany |
| Research Site | Künzing | Germany |
| Research Site | Nuremberg | Germany |
| Research Site | Pirna | Germany |
| Research Site | Hong Kong | Hong Kong |
| Research Site | Shatin | Hong Kong |
| Research Site | Balatonfüred | Hungary |
| Research Site | Budapest | Hungary |
| Research Site | Gy¿r | Hungary |
| Research Site | Kaposvár | Hungary |
| Research Site | Kecskemét | Hungary |
| Research Site | Miskolc | Hungary |
| Research Site | Siófok | Hungary |
| Research Site | Székesfehérvár | Hungary |
| Research Site | Mumbai | Mashatra | India |
| Research Site | Bangalore | India |
| Research Site | Delhi | India |
| Research Site | India | India |
| Research Site | Jakarta | DKI Jakarta | Indonesia |
| Research Site | Malang | East Java | Indonesia |
| Research Site | George Town | Malaysia |
| Research Site | Kuala Lumpur | Malaysia |
| Research Site | Petaling Jaya | Malaysia |
| Research Site | Bergen | Norway |
| Research Site | Bodø | Norway |
| Research Site | Elverum | Norway |
| Research Site | Fredrikstad | Norway |
| Research Site | Hamar | Norway |
| Research Site | Oslo | Norway |
| Research Site | Paradis | Norway |
| Research Site | Trondheim | Norway |
| Research Site | Tvedestrand | Norway |
| Research Site | Cebu City | Philippines |
| Research Site | Makati City | Philippines |
| Research Site | Manila | Philippines |
| Research Site | Almada | Portugal |
| Research Site | Amadora | Portugal |
| Research Site | Caldas da Rainha | Portugal |
| Research Site | Elvas | Portugal |
| Research Site | Lisbon | Portugal |
| Research Site | Portalegre | Portugal |
| Research Site | Moscow | Russia |
| Research Site | Saint Petersburg | Russia |
| Research Site | Yaroslavl | Russia |
| Research Site | Singapore | Singapore |
| Research Site | Cape Town | South Africa |
| Research Site | Durban | South Africa |
| Research Site | Johannesburg | South Africa |
| Research Site | Pretoria | South Africa |
| Research Site | Bern | Switzerland |
| Research Site | Chur | Switzerland |
| Research Site | Ilanz | Switzerland |
| Research Site | Lausanne | Switzerland |
| Research Site | Monthey | Switzerland |
| Research Site | Sion | Switzerland |
| Research Site | Zurich | Switzerland |
| Research Site | Yongkang District | Tainan County | Taiwan |
| Research Site | Changhua | Taiwan |
| Research Site | Taichung | Taiwan |
| Research Site | Taipei | Taiwan |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C501413 | tesaglitazar |
| D008687 | Metformin |
| D011345 | Fenofibrate |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D001577 | Benzophenones |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D007659 | Ketones |
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