HyperlipidemiaPhase 3ACTFAST SWISSNCT00136942
A Swiss Study With Atorvastatin in Hyperlipidemic Patients Measuring LDL-Cholesterol
A Phase 3 study testing Atorvastatin in people with Hyperlipidemia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 20 sites in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- Atorvastatin
- How many people
- 370 participants
- Where
- 20 sitesSwitzerland
- Study dates
- Apr 2005to not given
- Phase
- Phase 3
- 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
- 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.
Who cannot join
- Subjects receiving higher than "usual maintenance" doses of Lipid Lowering Therapy (LLT) at screening.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Switzerland20 sites
Pfizer Investigational Site
Basel, Canton of Basel-City
Pfizer Investigational Site
Binningen, Basel-Landschaft
Pfizer Investigational Site
Düdingen, Canton of Fribourg
Pfizer Investigational Site
Écublens, Canton of Vaud
Pfizer Investigational Site
Geneva, Canton of Geneva
Pfizer Investigational Site
Langenthal, Canton of Bern
Pfizer Investigational Site
Lausanne, Canton of Vaud
Pfizer Investigational Site
Liestal, Basel-Landschaft
Pfizer Investigational Site
Lugano, Canton Ticino
Pfizer Investigational Site
Malvaglia, Canton Ticino
Pfizer Investigational Site
Melide, Canton Ticino
Pfizer Investigational Site
Onex, Canton of Geneva
Pfizer Investigational Site
Pfaeffikon, Canton of Schwyz
Pfizer Investigational Site
Prilly, Canton of Vaud
Pfizer Investigational Site
Siebnen, Canton of Schwyz
Pfizer Investigational Site
Thun, Canton of Bern
Pfizer Investigational Site
Unterägeri, Canton of Zug
Pfizer Investigational Site
Vezia, Canton Ticino
Pfizer Investigational Site
Zug, Canton of Zug
Pfizer Investigational Site
Zurich, Canton of Zurich
About this study
Official title: 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.
- Conditions
- Hyperlipidemia
- Being tested
- Atorvastatin
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (1)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2005 (estimated)
- Study startApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 370 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
- NCT00136942
- Sponsor's protocol ID
- A2581089
- Acronym
- ACTFAST SWISS
- Status last verified
- Feb 2021
- First submitted
- 25 Aug 2005
- Last updated
- 18 Feb 2021
- Results posted
- No
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, 6-Week-Treatment, Open-Label Study Assessing The Percentage Of Hyperlipidemic Patients Achieving Low Density Lipoprotein Cholesterol Target With Atorvastatin
- ClinicalTrials.gov ID
- NCT00136942
- Acronym / sponsor ID
- ACTFAST SWISS / A2581089
- Conditions
- Hyperlipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 370 participants
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2005
- First posted
- 29 Aug 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 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Subjects receiving higher than "usual maintenance" doses of Lipid Lowering Therapy (LLT) at screening.
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 |
|---|---|---|
| Atorvastatin | Drug | – |
Primary outcome
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.
1 secondary outcome
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.
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.
- 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
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atorvastatin in people with Hyperlipidemia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 20 sites in Switzerland.
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 1 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 20 sites in Switzerland. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.