Double Blind Atorvastatin Amlodipine Study - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00159718

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Angina

Drug Information available for: Amlodipine Amlodipine besylate Atorvastatin Atorvastatin calcium

U.S. FDA Resources

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

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

Show 34 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org posting: This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	A0531031
Study First Received:	September 8, 2005
Last Updated:	January 29, 2008
ClinicalTrials.gov Identifier:	NCT00159718 History of Changes
Health Authority:	Poland: Ministry of Health

Additional relevant MeSH terms:

Antimetabolites
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Calcium Channel Blockers
Enzyme Inhibitors
Cardiovascular Agents
Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Antihypertensive Agents
Pharmacologic Actions
Amlodipine
Membrane Transport Modulators
Therapeutic Uses
Atorvastatin

ClinicalTrials.gov processed this record on February 08, 2010