Coronary ArteriosclerosisPhase 4CAPNCT00163202
Comparative Atorvastatin Pleiotropic Effects
A Phase 4 study testing Blood samples and Atorvastatin in people with Coronary Arteriosclerosis and Hypercholesterolemia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 74 sites in 7 countries.
Trial summary
The primary objective of the study is to evaluate the efficacy of atorvastatin 80 mg daily as compared to atorvastatin 10 mg daily in reducing C-reactive protein levels over a 26-week treatment period in subjects with documented coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Arteriosclerosis, Hypercholesterolemia
- What is being tested?
- Blood samples and Atorvastatin
- Type of treatment
- Surgery or procedure
- How many people
- 330 participants
- Where
- 74 sitesin 7 countries
- Study dates
- Jun 2002to Aug 2005
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects of age of majority to < 80 years
- Subjects with LDL-C > 0.5 g/L (1.29 mmol/L) and < 1.5 g/L (3.87 mmol/L), TG < 4.00 g/L (4.56 mmol/L) and hs-CRP >1.5 mg/L and < 15 mg/L
- Subjects with a documented coronary artery disease.
Who cannot join
- Female subjects of childbearing potential without contraception
- Subjects with secondary hyperlipidemia
- Diabetic subjects receiving insulin
- Subjects with a contra-indication to statin therapy.
Trial locations and contacts
74 sites in 7 countries.
74 sites in 7 countries
France36 sites
Pfizer Investigational Site
Besançon, 25030
Pfizer Investigational Site
Brest, 29609
Pfizer Investigational Site
Chambéry, 73000
Pfizer Investigational Site
Clamart, 92141
Pfizer Investigational Site
Clermont-Ferrand, Cedex, 63003
Pfizer Investigational Site
Clermont-Ferrand, 63003
Pfizer Investigational Site
Creil, 60100
Pfizer Investigational Site
Dijon, 21034
Pfizer Investigational Site
Évecquemont, 78740
Pfizer Investigational Site
Gap, 05000
Pfizer Investigational Site
Hénin-Beaumont, 62256
Pfizer Investigational Site
Langres, Cedex, 52206
Pfizer Investigational Site
Le Kremlin-Bicêtre, 94275
Pfizer Investigational Site
Lille, 59037
Pfizer Investigational Site
Marseille, 13385
Pfizer Investigational Site
Metz, 57038
Pfizer Investigational Site
Monaco, 98000
Pfizer Investigational Site
Montpellier, 34295
Pfizer Investigational Site
Mulhouse, 68070
Pfizer Investigational Site
Nancy, 54000
Pfizer Investigational Site
Nantes Saint Herblain, 44805
Pfizer Investigational Site
Paris, 75015
Pfizer Investigational Site
Paris, 75018
Pfizer Investigational Site
Paris, 75230
Pfizer Investigational Site
Paris, 75877
Pfizer Investigational Site
Paris, 75908
Pfizer Investigational Site
Pessac, 33064
Pfizer Investigational Site
Poissy, 78303
Pfizer Investigational Site
Pontoise, 95300
Pfizer Investigational Site
Roubaix, 59056
Pfizer Investigational Site
Saint-Michel, 16470
Pfizer Investigational Site
Thionville, 57100
Pfizer Investigational Site
Toulouse, 31403
Pfizer Investigational Site
Tourcoing, 59200
Pfizer Investigational Site
Vandœuvre-lès-Nancy, 54500
Pfizer Investigational Site
Vandœuvre-lès-Nancy, 54511
Canada19 sites
Pfizer Investigational Site
Calgary, Alberta, T2E 7C5
Pfizer Investigational Site
Chicoutimi, Quebec, G7H 5H6
Pfizer Investigational Site
Edmonton, Alberta, T6G 2S2
Pfizer Investigational Site
Halifax, Nova Scotia, B3H 2Y9
Pfizer Investigational Site
Laval, Quebec, H7V 2T8
Pfizer Investigational Site
London, Ontario, N6G 2V2
Pfizer Investigational Site
Montreal, Quebec, H1T 1C8
Pfizer Investigational Site
Montreal, Quebec, H1T 2M4
Pfizer Investigational Site
Montreal, Quebec, H2W 1R7
Pfizer Investigational Site
Montreal, Quebec, H4J 1C5
Pfizer Investigational Site
Oshawa, Ontario, L1J 2K1
Pfizer Investigational Site
Sarnia, Ontario, N7T 4X3
Pfizer Investigational Site
Saskatoon, Saskatchewan, S7N 0W8
Pfizer Investigational Site
Sherbrooke, Quebec, J1H 5N4
Pfizer Investigational Site
Ste-foy, Quebec, G1V 4G2
Pfizer Investigational Site
Toronto, Ontario, M5C 2T2
Pfizer Investigational Site
Vancouver, British Columbia, v6z 1y6
Pfizer Investigational Site
Weston, Ontario, M9N 1W4
Pfizer Investigational Site
Winnipeg, Manitoba, R3E 0Z3
Poland6 sites
Pfizer Investigational Site
Bełchatów, 97-400
Pfizer Investigational Site
Gdynia, 81-472
Pfizer Investigational Site
Rawa Mazowiecka, 96-200
Pfizer Investigational Site
Torun, 87-100
Pfizer Investigational Site
Wroclaw, 50-420
Pfizer Investigational Site
Zamość, 22-400
Czechia5 sites
Pfizer Investigational Site
Brno-Bohunice, 63900
Pfizer Investigational Site
Jindřichův Hradec, 377 38
Pfizer Investigational Site
Prague, 120 00
Pfizer Investigational Site
Prague, 128 08
Pfizer Investigational Site
Prague, 150 06
Romania3 sites
Pfizer Investigational Site
Bucharest, Sector 2, 70000
Pfizer Investigational Site
Bucharest, Sector 2, 7000
Pfizer Investigational Site
Bucharest, Sector 5, 76251
Russia3 sites
Pfizer Investigational Site
Moscow, 101953
Pfizer Investigational Site
Moscow, 121552
Pfizer Investigational Site
Volgograd, 400008
Slovakia2 sites
Pfizer Investigational Site
Bratislava, 81369
Pfizer Investigational Site
Bratislava, 83348
About this study
Official title: A Multicenter, Randomized Double-Blind Study Comparing The Pleiotropic Effects Of Atorvastatin 10 Mg And 80 Mg Over A 26-Week Period In Subjects With Coronary Atherosclerosis
The primary objective of the study is to evaluate the efficacy of atorvastatin 80 mg daily as compared to atorvastatin 10 mg daily in reducing C-reactive protein levels over a 26-week treatment period in subjects with documented coronary artery disease.
- Conditions
- Coronary Arteriosclerosis, Hypercholesterolemia
- Being tested
- Blood samples, Atorvastatin
- Medical subject headings
- Coronary Artery Disease, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesProcedure or surgery
AtorvastatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentages changes of the hs-CRP between baseline (means between week-2 to -1 and week 0 (V2) values) and week 26 (V5).
Secondary outcomes (1)
1/ the percentage change at visit 3 (5-week treatment), visit 4 (13-week-treatment) and visit 5 (26-week treatment) from baseline value in triglycerides, total cholesterol; HDL-cholesterol, LDL-cholesterol, apolipoprotein B 2/ the percentage change at
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study startJun 2002
- Study completionAug 2005
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 Coronary ArteriosclerosisStudies 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
- 330 participants
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MDS Pharma Services, Bio-Inova Life Sciences International
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00163202
- Sponsor's protocol ID
- A2581065
- Acronym
- CAP
- Status last verified
- Feb 2021
- First submitted
- 9 Sep 2005
- Last updated
- 18 Feb 2021
- Results posted
- No
Publications
Bonnet J, McPherson R, Tedgui A, Simoneau D, Nozza A, Martineau P, Davignon J; CAP Investigators. Comparative effects of 10-mg versus 80-mg Atorvastatin on high-sensitivity C-reactive protein in patients with stable coronary artery disease: results of the CAP (Comparative Atorvastatin Pleiotropic effects) study. Clin Ther. 2008 Dec;30(12):2298-313. doi: 10.1016/j.clinthera.2008.12.023.
PubMed 19167589
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Double-Blind Study Comparing The Pleiotropic Effects Of Atorvastatin 10 Mg And 80 Mg Over A 26-Week Period In Subjects With Coronary Atherosclerosis
- ClinicalTrials.gov ID
- NCT00163202
- Acronym / sponsor ID
- CAP / A2581065
- Conditions
- Coronary Arteriosclerosis, Hypercholesterolemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Collaborators
- MDS Pharma Services, Bio-Inova Life Sciences International
- Study start
- Jun 2002
- Study completion
- Aug 2005 (actual)
- First posted
- 13 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.
The primary objective of the study is to evaluate the efficacy of atorvastatin 80 mg daily as compared to atorvastatin 10 mg daily in reducing C-reactive protein levels over a 26-week treatment period in subjects with documented coronary artery disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female subjects of age of majority to < 80 years
- Subjects with LDL-C > 0.5 g/L (1.29 mmol/L) and < 1.5 g/L (3.87 mmol/L), TG < 4.00 g/L (4.56 mmol/L) and hs-CRP >1.5 mg/L and < 15 mg/L
- Subjects with a documented coronary artery disease.
Key exclusion criteria (4 listed)
- Female subjects of childbearing potential without contraception
- Subjects with secondary hyperlipidemia
- Diabetic subjects receiving insulin
- Subjects with a contra-indication to statin therapy.
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 |
|---|---|---|
| Blood samples | Procedure or surgery | – |
| Atorvastatin | Drug | – |
Primary outcome
Percentages changes of the hs-CRP between baseline (means between week-2 to -1 and week 0 (V2) values) and week 26 (V5).
1 secondary outcome
1/ the percentage change at visit 3 (5-week treatment), visit 4 (13-week-treatment) and visit 5 (26-week treatment) from baseline value in triglycerides, total cholesterol; HDL-cholesterol, LDL-cholesterol, apolipoprotein B 2/ the percentage change at
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 18 Feb 2021.
- Derived from this study: PubMed 19167589Bonnet J, McPherson R, Tedgui A, Simoneau D, Nozza A, Martineau P, Davignon J; CAP Investigators. Comparative effects of 10-mg versus 80-mg Atorvastatin on high-sensitivity C-reactive protein in patients with stable coronary artery disease: results of the CAP (Comparative Atorvastatin Pleiotropic effects) study. Clin Ther. 2008 Dec;30(12):2298-313. doi: 10.1016/j.clinthera.2008.12.023.
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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
74 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Blood samples and Atorvastatin in people with Coronary Arteriosclerosis and Hypercholesterolemia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 74 sites in 7 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 3 inclusion and 4 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 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 74 sites in France, Canada, Poland, Czechia, Romania and 2 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?
Percentages changes of the hs-CRP between baseline (means between week-2 to -1 and week 0 (V2) values) and week 26 (V5).. 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 NCT00163202, 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 18 Feb 2021.