Double Blind Atorvastatin Amlodipine Study

NCT00159718 | Completed Phase 4

• 1 other identifier: A0531031
• Study Type: interventional
• Target: 360
• Locations: 11 countries
• Sites: 32

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.

Conditions

Angina

Outcome Measures

Primary Outcomes (1)

• 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),

Interventions

amlodipine DRUG

atorvastatin DRUG

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (33)

Pfizer Investigational Site

Rijeka, Croatia

Location

Pfizer Investigational Site

Zagreb, Croatia

Location

Pfizer Investigational Site

Ostrava-Kunčice, Czechia

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Pfizer Investigational Site

Pilsen, Czechia

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Pfizer Investigational Site

Prague, Czechia

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Pfizer Investigational Site

Příbram, Czechia

Location

Pfizer Investigational Site

Rokycany, Czechia

Location

Pfizer Investigational Site

Tallinn, Estonia

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Pfizer Investigational Site

Tartu, Estonia

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Pfizer Investigational Site

Debrecen, Budapest, Hungary

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Pfizer Investigational Site

Balatonfüred, Hungary

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Pfizer Investigational Site

Berettyóújfalu, Hungary

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Pfizer Investigational Site

Budapest, Hungary

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Pfizer Investigational Site

Zalaegerszeg, Hungary

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Pfizer Investigational Site

Daugavpils, Latvia

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Pfizer Investigational Site

Riga, Latvia

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Pfizer Investigational Site

Valmiera, Latvia

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Pfizer Investigational Site

Baerum Postterminal, Norway

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Pfizer Investigational Site

Oslo, Norway

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Pfizer Investigational Site

Bytom, Poland

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Pfizer Investigational Site

Katowice, Poland

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Pfizer Investigational Site

Poznan, Poland

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Pfizer Investigational Site

Warsaw, Poland

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Pfizer Investigational Site

Brasov, Jud. Brasov, Romania

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Pfizer Investigational Site

Bucharest, Romania

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Pfizer Investigational Site

Craiova, Romania

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Pfizer Investigational Site

Bratislava, Slovakia

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Pfizer Investigational Site

Observatory, CAPE, South Africa

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Pfizer Investigational Site

Parow, CAPE, South Africa

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Pfizer Investigational Site

Çapa, Istanbul, Turkey (Türkiye)

Location

Pfizer Investigational Site

Bornova/izmir, Turkey (Türkiye)

Location

Pfizer Investigational Site

Samsun, Turkey (Türkiye)

Location

Pfizer Investigational Site

Location

Related Publications (1)

• 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.

  PMID: 20494902 DERIVED

Related Links

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

MeSH Terms

Conditions

Angina Pectoris

Interventions

Amlodipine; Atorvastatin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: July 1, 2001
• Study Completion: January 1, 2007
• Last Updated: January 28, 2021

Record last verified: 2021-01

Locations

CZ (5); HU (5); LA (3); RO (3); TU (3); CR (2); PL (4); SL (1); NO (2); ES (2); ZA (2)