- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00136942
A Swiss Study With Atorvastatin in Hyperlipidemic Patients Measuring LDL-Cholesterol (ACTFAST SWISS)
February 17, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
A Multicenter, 6-Week-Treatment, Open-Label Study Assessing The Percentage Of Hyperlipidemic Patients Achieving Low Density Lipoprotein Cholesterol Target With Atorvastatin
The proportion of patients achieving LDL-C target as defined by Swiss cholesterol recommendations (AGLA-recommendations) across starting doses of 10 mg, 20 mg, 40 mg, and 80 mg of atorvastatin.
Study Overview
Study Type
Interventional
Enrollment
370
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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BE
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Langenthal, BE, Switzerland
- Pfizer Investigational Site
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Thun, BE, Switzerland
- Pfizer Investigational Site
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BL
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Binningen, BL, Switzerland
- Pfizer Investigational Site
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Liestal, BL, Switzerland
- Pfizer Investigational Site
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BS
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Basel, BS, Switzerland
- Pfizer Investigational Site
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FR
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Duedingen, FR, Switzerland
- Pfizer Investigational Site
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GE
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Geneve, GE, Switzerland
- Pfizer Investigational Site
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Onex, GE, Switzerland
- Pfizer Investigational Site
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SZ
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Pfaeffikon, SZ, Switzerland
- Pfizer Investigational Site
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Siebnen, SZ, Switzerland
- Pfizer Investigational Site
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TI
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Lugano, TI, Switzerland
- Pfizer Investigational Site
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Malvaglia, TI, Switzerland
- Pfizer Investigational Site
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Melide, TI, Switzerland
- Pfizer Investigational Site
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Vezia, TI, Switzerland
- Pfizer Investigational Site
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VD
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Ecublens, VD, Switzerland
- Pfizer Investigational Site
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Lausanne, VD, Switzerland
- Pfizer Investigational Site
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Prilly, VD, Switzerland
- Pfizer Investigational Site
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ZG
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Unteraegeri, ZG, Switzerland
- Pfizer Investigational Site
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Zug, ZG, Switzerland
- Pfizer Investigational Site
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ZH
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Zuerich, ZH, Switzerland
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Risk factors and diagnosis of dyslipidemia according to the AGLA-recommendations (see appendix B) at screening
- LDL-C < 6.0 mmol/l
- Triglyceride level < 5.0 mmol/l.
Exclusion Criteria:
- Subjects receiving higher than "usual maintenance" doses of Lipid Lowering Therapy (LLT) at screening.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The proportion of patients achieving LDL-C target as defined by local swiss AGLArecommendations across starting doses of 10 mg, 20 mg, 40 mg, and 80 mg of atorvastatin.
|
Secondary Outcome Measures
Outcome Measure |
---|
The proportion of patients across different AGLA-categories (primary and secondary prevention) achieving LDL-C target as defined by AGLA-recommendations across starting doses of 10 mg, 20 mg, 40 mg, and 80 mg of atorvastatin.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2005
Study Registration Dates
First Submitted
August 25, 2005
First Submitted That Met QC Criteria
August 25, 2005
First Posted (Estimate)
August 29, 2005
Study Record Updates
Last Update Posted (Actual)
February 18, 2021
Last Update Submitted That Met QC Criteria
February 17, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A2581089
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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