Double Blind Atorvastatin Amlodipine Study

Condition(s) targeted: Angina

Intervention: amlodipine (Drug); atorvastatin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

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

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

Primary outcome: 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 outcome:

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.

Minimum age: 21 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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.

Pfizer Investigational Site, Zagreb, Croatia

Pfizer Investigational Site, Rijeka, Croatia

Pfizer Investigational Site, Zagreb, Croatia

Pfizer Investigational Site, Ostrava - Kuncice, Czech Republic

Pfizer Investigational Site, Plzen, Czech Republic

Pfizer Investigational Site, Pribram, Czech Republic

Pfizer Investigational Site, 100 34 Praha 10, Czech Republic

Pfizer Investigational Site, Rokycany, Czech Republic

Pfizer Investigational Site, Tallinn, Estonia

Pfizer Investigational Site, Tartu, Estonia

Pfizer Investigational Site, BUDAPEST, Hungary

Pfizer Investigational Site, ZALAEGERSZEG, Hungary

Pfizer Investigational Site, BALATONFURED, Hungary

Pfizer Investigational Site, BERETTYOUJFALU, Hungary

Pfizer Investigational Site, Riga, Latvia

Pfizer Investigational Site, Valmiera, Latvia

Pfizer Investigational Site, Daugavpils, Latvia

Pfizer Investigational Site, BAERUM POSTTERMINAL, Norway

Pfizer Investigational Site, Unknown, Norway

Pfizer Investigational Site, OSLO, Norway

Pfizer Investigational Site, BYTOM, Poland

Pfizer Investigational Site, Poznan, Poland

Pfizer Investigational Site, Warszawa, Poland

Pfizer Investigational Site, Katowice, Poland

Pfizer Investigational Site, Bucharest, Romania

Pfizer Investigational Site, Craiova, Romania

Pfizer Investigational Site, BRATISLAVA, Slovakia

Pfizer Investigational Site, SAMSUN, Turkey

Pfizer Investigational Site, BORNOVA/IZMIR, Turkey

Pfizer Investigational Site, DEBRECEN, BUDAPEST, Hungary

Pfizer Investigational Site, OBSERVATORY, CAPE, South Africa

Pfizer Investigational Site, PAROW, CAPE, South Africa

Pfizer Investigational Site, CAPA, ISTANBUL, Turkey

Pfizer Investigational Site, Brasov, Jud. Brasov, Romania

To obtain contact information for a study center near you, click here.

Link to ClinicalStudyResults.org posting:

Starting date: July 2001
Ending date: January 2007
Last updated: January 29, 2008