Official Title: “Double Blind Atorvastatin Amlodipine Study (DUAAL) Effect Of Amlodipine, Atorvastatin And The Combination On Transient Myocardia Ischemia In Coronary Artery Disease.”

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 Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: amlodipine
• Drug: atorvastatin

Primary Measures

• 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).

Secondary Measures

• 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.

Inclusion Criteria:

• Holter monitoring at baseline which demonstrates a total of 15 minutes of ischemia and/or 3 ischemic events per 48 hours.
• Total cholesterol > 5.2 mmol/L (200 mg/dL) on diet alone.

Exclusion Criteria:

• Myocardial infarction within 2 months prior to the study.
• Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00159718

Study ID Number: A0531031

ClinicalTrials.gov Identifier: NCT00159718

Health Authority: Poland: Ministry of Health

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Link to ClinicalStudyResults.org posting: