Double Blind Atorvastatin Amlodipine Study

NCT00159718

Last updated date
Study Location
Pfizer Investigational Site
Rijeka, , , Croatia
Contact
1-800-718-1021

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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Angina
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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AnginaDouble Blind Atorvastatin Amlodipine Study NCT00159718
  1. Rijeka,
  2. Zagreb,
  3. Ostrava - Kuncice,
  4. Plzen,
  5. Praha,
  6. Pribram,
  7. Rokycany,
  8. Tallinn,
  9. Tartu,
  10. Debrecen, Budapest
  11. Balatonfured,
  12. Berettyoujfalu,
  13. Budapest,
  14. Zalaegerszeg,
  15. Daugavpils,
  16. Riga,
  17. Valmiera,
  18. Baerum Postterminal,
  19. Oslo,
  20. Bytom,
  21. Katowice,
  22. Poznan,
  23. Warszawa,
  24. Brasov, Jud. Brasov
  25. Bucharest,
  26. Craiova,
  27. Bratislava,
  28. Observatory, Cape
  29. Parow, Cape
  30. Capa, Istanbul
  31. Bornova/izmir,
  32. Samsun,
ALL GENDERS
21 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Double Blind Atorvastatin Amlodipine Study
Official Title  ICMJE Double Blind Atorvastatin Amlodipine Study (DUAAL) Effect Of Amlodipine, Atorvastatin And The Combination On Transient Myocardia Ischemia In Coronary Artery Disease.
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Angina
Intervention  ICMJE
  • Drug: amlodipine
  • Drug: atorvastatin
Study Arms  ICMJE Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 8, 2005)
360
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE January 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 21 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Croatia,   Czechia,   Estonia,   Hungary,   Latvia,   Norway,   Poland,   Romania,   Slovakia,   South Africa,   Turkey
Removed Location Countries Czech Republic,   Israel,   Italy
 
Administrative Information
NCT Number  ICMJE NCT00159718
Other Study ID Numbers  ICMJE A0531031
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP