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Double Blind Atorvastatin Amlodipine Study (DUAAL)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00159718
First received: September 8, 2005
Last updated: January 29, 2008
Last verified: January 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00159718

  Show 33 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00159718     History of Changes
Other Study ID Numbers: A0531031
Study First Received: September 8, 2005
Last Updated: January 29, 2008
Health Authority: Poland: Ministry of Health

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

ClinicalTrials.gov processed this record on November 25, 2014