Double Blind Atorvastatin Amlodipine Study

Angina Clinical Trial

— DUAAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00159718
• Other study ID #: A0531031
• Status: Completed
• Phase: Phase 4
• Start date: July 2001
• Est. completion date: January 2007

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Angina

Intervention

Drug:
• amlodipine

• atorvastatin

Locations

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

Sponsors (1)

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

Countries where clinical trial is conducted

Croatia,  Czechia,  Estonia,  Hungary,  Latvia,  Norway,  Poland,  Romania,  Slovakia,  South Africa,  Turkey, 

Outcome

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

External Links

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