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To evaluate and compare the safety and efficacy of amlodipine, atorvastatin and the combination in patients with symptomatic myocardial ischemia.
Amlodipine's use in angina has been well documented in clinical trials such as the Circadian Anti-Ischemia Program in Europe (CAPE), but the impact on vascular inflammation in clinical practice has not been tested. Furthermore, the potentially synergistic benefit of atorvastatin and amlodipine on inflammation ischemic activity has not been studied.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| amlodipine | Drug | |||
| atorvastatin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| From the 48 hour holter monitoring the number of ischemic episodes will be assessed at baseline (week 1), week 18 and at the final visit (week 26). |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory markers will be assessed at baseline (week 2), week 6, week 18 and | ||
| week 26. Inflammatory markers to be analyzed are the following: C-reactive | ||
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Rijeka | Croatia | ||||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20494902 | Derived | Deanfield JE, Sellier P, Thaulow E, Bultas J, Yunis C, Shi H, Buch J, Beckerman B. Potent anti-ischaemic effects of statins in chronic stable angina: incremental benefit beyond lipid lowering? Eur Heart J. 2010 Nov;31(21):2650-9. doi: 10.1093/eurheartj/ehq133. Epub 2010 May 21. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| protein, amyloid A and interleukin 6. |
| From the exercise tolerance tests the time to onset of 1 mm ST depression, time to |
| onset of angina and total exercise time will be assessed at baseline (week 2), |
| week 18 and week 26. |
| Zagreb |
| Croatia |
| Pfizer Investigational Site | Ostrava-Kunčice | Czechia |
| Pfizer Investigational Site | Pilsen | Czechia |
| Pfizer Investigational Site | Prague | Czechia |
| Pfizer Investigational Site | Příbram | Czechia |
| Pfizer Investigational Site | Rokycany | Czechia |
| Pfizer Investigational Site | Tallinn | Estonia |
| Pfizer Investigational Site | Tartu | Estonia |
| Pfizer Investigational Site | Debrecen | Budapest | Hungary |
| Pfizer Investigational Site | Balatonfüred | Hungary |
| Pfizer Investigational Site | Berettyóújfalu | Hungary |
| Pfizer Investigational Site | Budapest | Hungary |
| Pfizer Investigational Site | Zalaegerszeg | Hungary |
| Pfizer Investigational Site | Daugavpils | Latvia |
| Pfizer Investigational Site | Riga | Latvia |
| Pfizer Investigational Site | Valmiera | Latvia |
| Pfizer Investigational Site | Baerum Postterminal | Norway |
| Pfizer Investigational Site | Oslo | Norway |
| Pfizer Investigational Site | Bytom | Poland |
| Pfizer Investigational Site | Katowice | Poland |
| Pfizer Investigational Site | Poznan | Poland |
| Pfizer Investigational Site | Warsaw | Poland |
| Pfizer Investigational Site | Brasov | Jud. Brasov | Romania |
| Pfizer Investigational Site | Bucharest | Romania |
| Pfizer Investigational Site | Craiova | Romania |
| Pfizer Investigational Site | Bratislava | Slovakia |
| Pfizer Investigational Site | Observatory | CAPE | South Africa |
| Pfizer Investigational Site | Parow | CAPE | South Africa |
| Pfizer Investigational Site | Çapa | Istanbul | Turkey (Türkiye) |
| Pfizer Investigational Site | Bornova/izmir | Turkey (Türkiye) |
| Pfizer Investigational Site | Samsun | Turkey (Türkiye) |
| Pfizer Investigational Site |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017311 | Amlodipine |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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