Double Blind Atorvastatin Amlodipine Study (DUAAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00159718
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : January 31, 2008
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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.

Condition or disease Intervention/treatment Phase
Angina Drug: amlodipine Drug: atorvastatin Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Double Blind Atorvastatin Amlodipine Study (DUAAL) Effect Of Amlodipine, Atorvastatin And The Combination On Transient Myocardia Ischemia In Coronary Artery Disease.
Study Start Date : July 2001
Study Completion Date : January 2007

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00159718

  Show 32 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00159718     History of Changes
Other Study ID Numbers: A0531031
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: January 31, 2008
Last Verified: January 2008

Additional relevant MeSH terms:
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Vasodilator Agents