Double Blind Atorvastatin Amlodipine Study (DUAAL)

Viatris

Status and phase

Completed

Phase 4

Conditions

Angina

Treatments

Drug: amlodipine

Drug: atorvastatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00159718

A0531031

Details and patient eligibility

About

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.

Sex

All

Ages

21 to 80 years old

Volunteers

No Healthy Volunteers

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.