AnginaPhase 4DUAALNCT00159718
Double Blind Atorvastatin Amlodipine Study
A Phase 4 study testing amlodipine and atorvastatin in people with Angina, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 33 sites in 12 countries.
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… Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Angina
- What is being tested?
- amlodipine and atorvastatin
- How many people
- 360 participants
- Where
- 33 sitesin 12 countries
- Study dates
- Jul 2001to Jan 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
33 sites in 12 countries.
33 sites in 12 countries
Czechia5 sites
Pfizer Investigational Site
Ostrava-Kunčice
Pfizer Investigational Site
Pilsen
Pfizer Investigational Site
Prague
Pfizer Investigational Site
Příbram
Pfizer Investigational Site
Rokycany
Hungary5 sites
Pfizer Investigational Site
Balatonfüred
Pfizer Investigational Site
Berettyóújfalu
Pfizer Investigational Site
Budapest
Pfizer Investigational Site
Debrecen, Budapest
Pfizer Investigational Site
Zalaegerszeg
Poland4 sites
Pfizer Investigational Site
Bytom
Pfizer Investigational Site
Katowice
Pfizer Investigational Site
Poznan
Pfizer Investigational Site
Warsaw
Latvia3 sites
Pfizer Investigational Site
Daugavpils
Pfizer Investigational Site
Riga
Pfizer Investigational Site
Valmiera
Romania3 sites
Pfizer Investigational Site
Brasov, Jud. Brasov
Pfizer Investigational Site
Bucharest
Pfizer Investigational Site
Craiova
Turkey (Türkiye)3 sites
Pfizer Investigational Site
Bornova/izmir
Pfizer Investigational Site
Çapa, Istanbul
Pfizer Investigational Site
Samsun
Croatia2 sites
Pfizer Investigational Site
Rijeka
Pfizer Investigational Site
Zagreb
Estonia2 sites
Pfizer Investigational Site
Tallinn
Pfizer Investigational Site
Tartu
Norway2 sites
Pfizer Investigational Site
Baerum Postterminal
Pfizer Investigational Site
Oslo
South Africa2 sites
Pfizer Investigational Site
Observatory, CAPE
Pfizer Investigational Site
Parow, CAPE
Location not given1 site
Pfizer Investigational Site
About this study
Official title: 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.
- Conditions
- Angina
- Being tested
- amlodipine, atorvastatin
- Medical subject headings
- Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amlodipineDrug
atorvastatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (6)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJul 2001
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnginaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 360 participants
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00159718
- Sponsor's protocol ID
- A0531031
- Acronym
- DUAAL
- Status last verified
- Jan 2021
- First submitted
- 8 Sep 2005
- Last updated
- 28 Jan 2021
- Results posted
- No
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.
PubMed 20494902
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Atorvastatin Amlodipine Study (DUAAL) Effect Of Amlodipine, Atorvastatin And The Combination On Transient Myocardia Ischemia In Coronary Artery Disease.
- ClinicalTrials.gov ID
- NCT00159718
- Acronym / sponsor ID
- DUAAL / A0531031
- Conditions
- Angina
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2001
- Study completion
- Jan 2007
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| amlodipine | Drug | – |
| atorvastatin | Drug | – |
Primary outcome
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).
6 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Derived from this study: PubMed 20494902Deanfield 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.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
33 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing amlodipine and atorvastatin in people with Angina, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 33 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Czechia, Hungary, Poland, Latvia, Romania and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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).. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00159718, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021.