We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Double Blind Atorvastatin Amlodipine Study (DUAAL)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00159718
First Posted: September 12, 2005
Last Update Posted: January 31, 2008
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.
Information provided by:
Pfizer
  Purpose

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 Intervention Phase
Angina Drug: amlodipine Drug: atorvastatin Phase 4

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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:
  • Inflammatory markers will be assessed at baseline (week 2), week 6, week 18 and
  • week 26. Inflammatory markers to be analyzed are the following: C-reactive
  • protein, amyloid A and interleukin 6.
  • From the exercise tolerance tests the time to onset of 1 mm ST depression, time to
  • onset of angina and total exercise time will be assessed at baseline (week 2),
  • week 18 and week 26.

Estimated Enrollment: 360
Study Start Date: July 2001
Estimated Study Completion Date: January 2007
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00159718


  Show 32 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00159718     History of Changes
Other Study ID Numbers: A0531031
First Submitted: September 8, 2005
First Posted: September 12, 2005
Last Update Posted: January 31, 2008
Last Verified: January 2008

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