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	Intervention	Phase
Angina	Drug: amlodipine  Drug: atorvastatin	Phase IV

Further Study Details: 

Primary Outcomes: 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: 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
Expected Total Enrollment:  360

Ages Eligible for Study:  21 Years   -   80 Years,  Genders Eligible for Study:  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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00159718

Pfizer CT.gov Call Center      1-800-718-1021 

Croatia
      Pfizer Investigational Site, Zagreb,  10 000,  Croatia; Recruiting
      Pfizer Investigational Site, Zagreb,  10 000,  Croatia; Recruiting
      Pfizer Investigational Site, Rijeka,  51 000,  Croatia; Recruiting
      Pfizer Investigational Site, Zagreb,  10 000,  Croatia; Recruiting
Czech Republic
      Pfizer Investigational Site, OSTRAVA - KUN ICE,  719 00,  Czech Republic; Recruiting
      Pfizer Investigational Site, Plzen,  323 33,  Czech Republic; Recruiting
      Pfizer Investigational Site, Pribram,  26101,  Czech Republic; Recruiting
      Pfizer Investigational Site, 100 34 Praha 10,  Czech Republic; Recruiting
Estonia
      Pfizer Investigational Site, Tallinn,  13419,  Estonia; Recruiting
      Pfizer Investigational Site, Tartu,  51014,  Estonia; Recruiting
      Pfizer Investigational Site, Tallinn,  10138,  Estonia; Recruiting
      Pfizer Investigational Site, Tallinn,  10138,  Estonia; Recruiting
Hungary
      Pfizer Investigational Site, Zalaegerszeg,  8900,  Hungary; Recruiting
      Pfizer Investigational Site, Balatonfured,  8230,  Hungary; Recruiting
      Pfizer Investigational Site, BERETTYOUJFALU,  H-4100,  Hungary; No longer recruiting
Hungary, BUDAPEST
      Pfizer Investigational Site, Debrecen,  BUDAPEST,  4012,  Hungary; Completed
Latvia
      Pfizer Investigational Site, Riga,  LV - 1002,  Latvia; No longer recruiting
      Pfizer Investigational Site, Valmiera,  LV - 4201,  Latvia; Recruiting
      Pfizer Investigational Site, Daugavpils,  LV - 5417,  Latvia; Recruiting
Norway
      Pfizer Investigational Site, Baerum Postterminal,  1355,  Norway; No longer recruiting
Poland
      Pfizer Investigational Site, Bytom,  41-900,  Poland; Recruiting
      Pfizer Investigational Site, Poznan,  61-848,  Poland; No longer recruiting
      Pfizer Investigational Site, Warszawa,  02-097,  Poland; No longer recruiting
      Pfizer Investigational Site, Katowice,  40-635,  Poland; Recruiting
Romania
      Pfizer Investigational Site, Bucharest,  022328,  Romania; No longer recruiting
      Pfizer Investigational Site, Craiova,  200322,  Romania; No longer recruiting
Romania, Jud. Brasov
      Pfizer Investigational Site, Brasov,  Jud. Brasov,  500157,  Romania; No longer recruiting
Slovakia
      Pfizer Investigational Site, BRATISLAVA,  81369,  Slovakia; Recruiting
      Pfizer Investigational Site, BRATISLAVA,  83305,  Slovakia; Recruiting
      Pfizer Investigational Site, BRATISLAVA,  83348,  Slovakia; Recruiting
South Africa, CAPE
      Pfizer Investigational Site, Observatory,  CAPE,  7925,  South Africa; No longer recruiting
      Pfizer Investigational Site, PAROW,  CAPE,  7500,  South Africa; No longer recruiting
Turkey
      Pfizer Investigational Site, SAMSUN,  55139,  Turkey; No longer recruiting
      Pfizer Investigational Site, BORNOVA/IZMIR,  Turkey; No longer recruiting
Turkey, ISTANBUL
      Pfizer Investigational Site, CAPA,  ISTANBUL,  34390,  Turkey; No longer recruiting

Study chairs or principal investigators

Pfizer CT.gov Call Center,  Study Director,  Pfizer   

Study ID Numbers:  A0531031
Last Updated:  September 11, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00159718
Health Authority: Poland: Ministry of Health
ClinicalTrials.gov processed this record on 2005-09-13