Double Blind Atorvastatin Amlodipine Study
Phase 4
Completed
- Conditions
- Angina
- Registration Number
- NCT00159718
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 360
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method onset of angina and total exercise time will be assessed at baseline (week 2), week 18 and week 26. week 26. Inflammatory markers to be analyzed are the following: C-reactive protein, amyloid A and interleukin 6. Inflammatory markers will be assessed at baseline (week 2), week 6, week 18 and From the exercise tolerance tests the time to onset of 1 mm ST depression, time to
Trial Locations
- Locations (1)
Pfizer Investigational Site