Double Blind Atorvastatin Amlodipine Study (DUAAL)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Double Blind Atorvastatin Amlodipine Study (DUAAL) Effect Of Amlodipine, Atorvastatin And The Combination On Transient Myocardia Ischemia In Coronary Artery Disease.|
- 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).
- 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
- 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.
|Study Start Date:||July 2001|
|Estimated Study Completion Date:||January 2007|
Show 33 Study Locations
|Study Director:||Pfizer CT.gov Call Center||Pfizer|