Clinical trial NCT00159718: Double Blind Atorvastatin Amlodipine Study
Official title: Double Blind Atorvastatin Amlodipine Study (DUAAL) Effect Of Amlodipine, Atorvastatin And The Combination On Transient Myocardia Ischemia In Coronary Artery Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Angina
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 360
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: 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 outcomes:
measure: Inflammatory markers will be assessed at baseline (week 2), week 6, week 18 and
measure: week 26. Inflammatory markers to be analyzed are the following: C-reactive
measure: protein, amyloid A and interleukin 6.
measure: From the exercise tolerance tests the time to onset of 1 mm ST depression, time to
measure: onset of angina and total exercise time will be assessed at baseline (week 2),
measure: week 18 and week 26.
Other outcomes:
Locations:
city: Rijeka
country: Croatia
facility: Pfizer Investigational Site
city: Zagreb
country: Croatia
facility: Pfizer Investigational Site
city: Ostrava - Kuncice
country: Czechia
facility: Pfizer Investigational Site
city: Plzen
country: Czechia
facility: Pfizer Investigational Site
city: Praha
country: Czechia
facility: Pfizer Investigational Site
city: Pribram
country: Czechia
facility: Pfizer Investigational Site
city: Rokycany
country: Czechia
facility: Pfizer Investigational Site
city: Tallinn
country: Estonia
facility: Pfizer Investigational Site
city: Tartu
country: Estonia
facility: Pfizer Investigational Site
city: Debrecen
country: Hungary
facility: Pfizer Investigational Site
state: Budapest
city: Balatonfured
country: Hungary
facility: Pfizer Investigational Site
city: Berettyoujfalu
country: Hungary
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Zalaegerszeg
country: Hungary
facility: Pfizer Investigational Site
city: Daugavpils
country: Latvia
facility: Pfizer Investigational Site
city: Riga
country: Latvia
facility: Pfizer Investigational Site
city: Valmiera
country: Latvia
facility: Pfizer Investigational Site
city: Baerum Postterminal
country: Norway
facility: Pfizer Investigational Site
city: Oslo
country: Norway
facility: Pfizer Investigational Site
city: Bytom
country: Poland
facility: Pfizer Investigational Site
city: Katowice
country: Poland
facility: Pfizer Investigational Site
city: Poznan
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Brasov
country: Romania
facility: Pfizer Investigational Site
state: Jud. Brasov
city: Bucharest
country: Romania
facility: Pfizer Investigational Site
city: Craiova
country: Romania
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Observatory
country: South Africa
facility: Pfizer Investigational Site
state: Cape
city: Parow
country: South Africa
facility: Pfizer Investigational Site
state: Cape
city: Capa
country: Turkey
facility: Pfizer Investigational Site
state: Istanbul
city: Bornova/izmir
country: Turkey
facility: Pfizer Investigational Site
city: Samsun
country: Turkey
facility: Pfizer Investigational Site
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.