DyslipidemiasPhase 4NCT00644670
A Study Of The Efficacy Of Atorvastatin For Lowering Cholesterol In High-Risk Patients With High Cholesterol
A Phase 4 study testing Atorvastatin in people with Dyslipidemias, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 17 sites in Belgium.
Trial summary
The purpose of the study is to evaluate the effectiveness of atorvastatin in lowering cholesterol and getting these high risk patients to their goals of LDL <115 mg/dl across starting doses of 10 mg, 20 mg, or 40 mg with one step titration. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Dyslipidemias
- What is being tested?
- Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 17 sitesBelgium
- Study dates
- Jun 2003to Mar 2004
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dyslipidemia
- At a high risk for coronary heart disease
Who cannot join
- Use of higher than usual maintenance doses of statin drugs at screening
- Uncontrolled diabetes or high blood pressure
- Impaired liver function
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Belgium17 sites
Pfizer Investigational Site
Antwerp, 2018
Pfizer Investigational Site
Brasschaat, 2930
Pfizer Investigational Site
Brussels, 1180
Pfizer Investigational Site
Edegem, 2650
Pfizer Investigational Site
Genk, B-3600
Pfizer Investigational Site
Ghent, 9000
Pfizer Investigational Site
Gilly (charleroi), 6060
Pfizer Investigational Site
La Louvière, 7100
Pfizer Investigational Site
Liège, 4000
Pfizer Investigational Site
Mechelen, 2800
Pfizer Investigational Site
Menen, 8930
Pfizer Investigational Site
Merksem, 2170
Pfizer Investigational Site
Mortsel, 2640
Pfizer Investigational Site
Roeselare, 8800
Pfizer Investigational Site
Seraing, 4100
Pfizer Investigational Site
Wilrijk, 2610
Pfizer Investigational Site
Wingene, 8750
About this study
Official title: A Multicenter, Twelve-Week Treatment, Single-Step Titration, Open-Label Study Assessing The Percentage Of Dyslipidemic High-Risk Patients Achieving LDL Cholesterol Targets With Atorvastatin Starting Doses Of 10 Mg, 20 Mg And 40 Mg.
The purpose of the study is to evaluate the effectiveness of atorvastatin in lowering cholesterol and getting these high risk patients to their goals of LDL <115 mg/dl across starting doses of 10 mg, 20 mg, or 40 mg with one step titration.
- Conditions
- Dyslipidemias
- Being tested
- Atorvastatin
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
In previously treated patients, starting atorvastatin doses (oral tablets given once daily) of 20 mg (in patients with LDL-C levels between 115 and 164 mg/dL at baseline) or 40 mg (in patients with LDL-C levels between 165 and 235 mg/dL at baseline) were given for 6 weeks. If LDL-C target was achieved at Week 6, doses remained the same. If LDL-C target was not achieved at Week 6, doses were doubled.
AtorvastatinDrug
In statin-naive patients, starting atorvastatin doses (oral tablets given once daily) of 10 mg (in patients with LDL-C levels between 115 and 164 mg/dL at baseline), 20 mg (in patients with LDL-C levels between 165 and 174 mg/dL at baseline), or 40 mg (in patients with LDL-C levels between 175 and 235 mg/dL at baseline) were given for 6 weeks. If LDL-C target was achieved at Week 6, doses remained the same. If LDL-C target was not achieved at Week 6, doses were doubled.
| Study group | Role | What they receive |
|---|---|---|
| Previous Treatment with a Usual Maintenance Dose of a Statin | Experimental | Not described Receives: Drug: Atorvastatin |
| Statin-Naive | Experimental | Not described Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects in entire group who achieved low-density lipoprotein cholesterol (LDL-C) target of <115 mg/dL
Measured: Week 12
Secondary outcomes (7)
Mean percent change from baseline in LDL-C, high-density lipoprotein cholesterol (HDL-C), non-HDL-C (triglycerides of >200 mg/dL), total cholesterol, triglycerides, and apolipoprotein B for statin-naive patients
Measured: Weeks 6 and 12
Proportion of subjects across different LDL-C strata who achieved LDL-C target
Measured: Week 6
Proportion of diabetic subjects in entire group who achieved LDL-C target
Measured: Week 12
Proportion of subject on statin therapy at baseline who achieved LDL-C target and total cholesterol target (<190 mg/dL)
Measured: Week 12
Change from baseline in hemoglobin A1c levels
Measured: Week 12
Adverse events and laboratory test changes
Measured: Weeks 6 and 12
Proportion of subjects in entire group who achieved LDL-C target
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2008 (estimated)
- Study startJun 2003
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiasStudies 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
- None (open label)
- Enrolment
- 232 participants (actual)
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
- NCT00644670
- Sponsor's protocol ID
- A2581099
- Status last verified
- Feb 2021
- First submitted
- 24 Mar 2008
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- 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, Twelve-Week Treatment, Single-Step Titration, Open-Label Study Assessing The Percentage Of Dyslipidemic High-Risk Patients Achieving LDL Cholesterol Targets With Atorvastatin Starting Doses Of 10 Mg, 20 Mg And 40 Mg.
- ClinicalTrials.gov ID
- NCT00644670
- Acronym / sponsor ID
- A2581099
- Conditions
- Dyslipidemias
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2003
- Study completion
- Mar 2004 (actual)
- First posted
- 27 Mar 2008 (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 purpose of the study is to evaluate the effectiveness of atorvastatin in lowering cholesterol and getting these high risk patients to their goals of LDL <115 mg/dl across starting doses of 10 mg, 20 mg, or 40 mg with one step titration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Previous Treatment with a Usual Maintenance Dose of a Statin | Experimental | Drug: Atorvastatin |
| Statin-Naive | Experimental | Drug: Atorvastatin |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Dyslipidemia
- At a high risk for coronary heart disease
Key exclusion criteria (3 listed)
- Use of higher than usual maintenance doses of statin drugs at screening
- Uncontrolled diabetes or high blood pressure
- Impaired liver function
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 |
|---|---|---|
| AtorvastatinIn previously treated patients, starting atorvastatin doses (oral tablets given once daily) of 20 mg (in patients with LDL-C levels between 115 and 164 mg/dL at baseline) or 40 mg (in patients with LDL-C levels between 165 and 235 mg/dL at baseline) were given for 6 weeks. If LDL-C target was achieved at Week 6, doses remained the same. If LDL-C target was not achieved at Week 6, doses were doubled. | Drug | Previous Treatment with a Usual Maintenance Dose of a Statin |
| AtorvastatinIn statin-naive patients, starting atorvastatin doses (oral tablets given once daily) of 10 mg (in patients with LDL-C levels between 115 and 164 mg/dL at baseline), 20 mg (in patients with LDL-C levels between 165 and 174 mg/dL at baseline), or 40 mg (in patients with LDL-C levels between 175 and 235 mg/dL at baseline) were given for 6 weeks. If LDL-C target was achieved at Week 6, doses remained the same. If LDL-C target was not achieved at Week 6, doses were doubled. | Drug | Statin-Naive |
Primary outcome
Percentage of subjects in entire group who achieved low-density lipoprotein cholesterol (LDL-C) target of <115 mg/dL
Time frame: Week 12
7 secondary outcomes
Mean percent change from baseline in LDL-C, high-density lipoprotein cholesterol (HDL-C), non-HDL-C (triglycerides of >200 mg/dL), total cholesterol, triglycerides, and apolipoprotein B for statin-naive patients
Time frame: Weeks 6 and 12
Proportion of subjects across different LDL-C strata who achieved LDL-C target
Time frame: Week 6
Proportion of diabetic subjects in entire group who achieved LDL-C target
Time frame: Week 12
Proportion of subject on statin therapy at baseline who achieved LDL-C target and total cholesterol target (<190 mg/dL)
Time frame: Week 12
Change from baseline in hemoglobin A1c levels
Time frame: Week 12
Adverse events and laboratory test changes
Time frame: Weeks 6 and 12
Proportion of subjects in entire group who achieved LDL-C target
Time frame: Week 6
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
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atorvastatin in people with Dyslipidemias, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 17 sites in Belgium.
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 2 inclusion and 3 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 17 sites in Belgium. 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?
Percentage of subjects in entire group who achieved low-density lipoprotein cholesterol (LDL-C) target of <115 mg/dL (time frame: Week 12). 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.