Double Blind Atorvastatin Amlodipine Study (DUAAL)

January 26, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

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.

Study Overview

Status

Completed

Conditions

Angina

Intervention / Treatment

Study Type

Interventional

Enrollment

360

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

- - - Pfizer Investigational Site
Croatia
- - Rijeka, Croatia
    - Pfizer Investigational Site
  - Zagreb, Croatia
    - Pfizer Investigational Site
Czechia
- - Ostrava - Kuncice, Czechia
    - Pfizer Investigational Site
  - Plzen, Czechia
    - Pfizer Investigational Site
  - Praha, Czechia
    - Pfizer Investigational Site
  - Pribram, Czechia
    - Pfizer Investigational Site
  - Rokycany, Czechia
    - Pfizer Investigational Site
Estonia
- - Tallinn, Estonia
    - Pfizer Investigational Site
  - Tartu, Estonia
    - Pfizer Investigational Site
Hungary
- - Balatonfured, Hungary
    - Pfizer Investigational Site
  - Berettyoujfalu, Hungary
    - Pfizer Investigational Site
  - Budapest, Hungary
    - Pfizer Investigational Site
  - Zalaegerszeg, Hungary
    - Pfizer Investigational Site
- Budapest
  - Debrecen, Budapest, Hungary
    - Pfizer Investigational Site
Latvia
- - Daugavpils, Latvia
    - Pfizer Investigational Site
  - Riga, Latvia
    - Pfizer Investigational Site
  - Valmiera, Latvia
    - Pfizer Investigational Site
Norway
- - Baerum Postterminal, Norway
    - Pfizer Investigational Site
  - Oslo, Norway
    - Pfizer Investigational Site
Poland
- - Bytom, Poland
    - Pfizer Investigational Site
  - Katowice, Poland
    - Pfizer Investigational Site
  - Poznan, Poland
    - Pfizer Investigational Site
  - Warszawa, Poland
    - Pfizer Investigational Site
Romania
- - Bucharest, Romania
    - Pfizer Investigational Site
  - Craiova, Romania
    - Pfizer Investigational Site
- Jud. Brasov
  - Brasov, Jud. Brasov, Romania
    - Pfizer Investigational Site
Slovakia
- - Bratislava, Slovakia
    - Pfizer Investigational Site
South Africa
- Cape
  - Observatory, Cape, South Africa
    - Pfizer Investigational Site
  - Parow, Cape, South Africa
    - Pfizer Investigational Site
Turkey
- - Bornova/izmir, Turkey
    - Pfizer Investigational Site
  - Samsun, Turkey
    - Pfizer Investigational Site
- Istanbul
  - Capa, Istanbul, Turkey
    - Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Deanfield JE, Sellier P, Thaulow E, Bultas J, Yunis C, Shi H, Buch J, Beckerman B. Potent anti-ischaemic effects of statins in chronic stable angina: incremental benefit beyond lipid lowering? Eur Heart J. 2010 Nov;31(21):2650-9. doi: 10.1093/eurheartj/ehq133. Epub 2010 May 21.

Helpful Links

To obtain contact information for a study center near you, click here.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2001

Study Completion

January 1, 2007

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Actual)

January 28, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

A0531031

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.