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OpenTrials
Completed

NCT Number: NCT00159718

Double Blind Atorvastatin Amlodipine Study

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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Key information

Conditions

Angina Angina Pectoris Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Rijeka, Croatia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Amlodipine

Drug

atorvastatin

Drug

Primary outcomes

  1. 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

  1. Inflammatory markers will be assessed at baseline (week 2), week 6, week 18 and

  2. week 26. Inflammatory markers to be analyzed are the following: C-reactive

  3. protein, amyloid A and interleukin 6.

  4. From the exercise tolerance tests the time to onset of 1 mm ST depression, time to

  5. onset of angina and total exercise time will be assessed at baseline (week 2),

  6. week 18 and week 26.

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study title

Double Blind Atorvastatin Amlodipine Study (DUAAL) Effect Of Amlodipine, Atorvastatin And The Combination On Transient Myocardia Ischemia In Coronary Artery Disease.

Acronym: DUAAL

Important dates

Study start
2001
Study completion
2007
First posted
Sep 12, 2005
Registry last updated
Jan 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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