Double Blind Atorvastatin Amlodipine Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-07-31

Study Completion Date

2007-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Angina

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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amlodipine

Intervention Type DRUG

atorvastatin

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No