Double Blind Atorvastatin Amlodipine Study (DUAAL)
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|ClinicalTrials.gov Identifier: NCT00159718|
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : January 31, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Angina||Drug: amlodipine Drug: atorvastatin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||360 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Double Blind Atorvastatin Amlodipine Study (DUAAL) Effect Of Amlodipine, Atorvastatin And The Combination On Transient Myocardia Ischemia In Coronary Artery Disease.|
|Study Start Date :||July 2001|
|Study Completion Date :||January 2007|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00159718
Show 32 Study Locations
|Study Director:||Pfizer CT.gov Call Center||Pfizer|