DyslipidemiasPhase 4NCT00644709
A Study Of Atorvastatin For The Treatment Of High Cholesterol In Patients At High Risk Of Coronary Heart Disease (CHD)
A Phase 4 study testing Atorvastatin in people with Dyslipidemias, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 15 sites in Belgium.
Trial summary
A study of the long-term (1 year) effectiveness of atorvastatin to keep patients of high cardiovascular risk at the LDL cholesterol goal of <115 mg/dL 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
- 196 participants
- Where
- 15 sitesBelgium
- Study dates
- Sep 2003to Mar 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completion of base study
- Dyslipidemia and at high risk of CHD
Who cannot join
- Impaired liver function
- Gastrointestinal disease that could limit drug absorption
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Belgium15 sites
Pfizer Investigational Site
Antwerp, 2018
Pfizer Investigational Site
Brasschaat, 2930
Pfizer Investigational Site
Brussels, 1180
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
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, Open-Label Extension Study Of High-Risk Hyperlipidemic Patients Treated With An Atorvastatin Starting Dose Adapted To Their Baseline LDL-C Level
A study of the long-term (1 year) effectiveness of atorvastatin to keep patients of high cardiovascular risk at the LDL cholesterol goal of <115 mg/dL
- 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
Atorvastatin tablets at starting doses of 10, 20, 40, or 80 mg once daily. Three dose adjustments were allowed at baseline, Week 17, and Week 34. Patients who did not meet the LDL-C target at any of these time points had their doses doubled except for those who were on the 80 mg dose. Treatment was given for 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Not described Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of low-density lipoprotein cholesterol (LDL-C) target of <115 mg/dL
Measured: Week 52
Secondary outcomes (7)
Achievement of LDL-C target and total cholesterol target (<190 mg/dL) concomitantly
Measured: Week 52
LDL-C, high-density lipoprotein cholesterol (HDL-C), total cholesterol, and triglyceride levels
Measured: Baseline and Week 6 for base study; Baseline and Weeks 17, 34, and 52 for extension study
Percent change from baseline of base study in LDL-C, HDL-C, non-HDL-C (triglycerides of >200 mg/dL), total cholesterol, and triglycerides in patients who were statin-naive at baseline of base study
Measured: Baseline and Weeks 17, 34, and 52
Achievement of LDL-C target grouped according to whether patients had achieved target at the start of this extension study
Measured: Week 52
Adverse events and laboratory test changes
Measured: Weeks 17, 34, and 52
Achievement of LDL-C target
Measured: Weeks 17 and 34
Achievement of LDL-C target by diabetic patients
Measured: Week 52
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 startSep 2003
- Study completionMar 2005
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 196 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
- NCT00644709
- Sponsor's protocol ID
- A2581112
- Status last verified
- Feb 2021
- First submitted
- 25 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, Open-Label Extension Study Of High-Risk Hyperlipidemic Patients Treated With An Atorvastatin Starting Dose Adapted To Their Baseline LDL-C Level
- ClinicalTrials.gov ID
- NCT00644709
- Acronym / sponsor ID
- A2581112
- Conditions
- Dyslipidemias
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2003
- Study completion
- Mar 2005 (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.
A study of the long-term (1 year) effectiveness of atorvastatin to keep patients of high cardiovascular risk at the LDL cholesterol goal of <115 mg/dL
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm A | 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)
- Completion of base study
- Dyslipidemia and at high risk of CHD
Key exclusion criteria (2 listed)
- Impaired liver function
- Gastrointestinal disease that could limit drug absorption
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 |
|---|---|---|
| AtorvastatinAtorvastatin tablets at starting doses of 10, 20, 40, or 80 mg once daily. Three dose adjustments were allowed at baseline, Week 17, and Week 34. Patients who did not meet the LDL-C target at any of these time points had their doses doubled except for those who were on the 80 mg dose. Treatment was given for 52 weeks. | Drug | Arm A |
Primary outcome
Achievement of low-density lipoprotein cholesterol (LDL-C) target of <115 mg/dL
Time frame: Week 52
7 secondary outcomes
Achievement of LDL-C target and total cholesterol target (<190 mg/dL) concomitantly
Time frame: Week 52
LDL-C, high-density lipoprotein cholesterol (HDL-C), total cholesterol, and triglyceride levels
Time frame: Baseline and Week 6 for base study; Baseline and Weeks 17, 34, and 52 for extension study
Percent change from baseline of base study in LDL-C, HDL-C, non-HDL-C (triglycerides of >200 mg/dL), total cholesterol, and triglycerides in patients who were statin-naive at baseline of base study
Time frame: Baseline and Weeks 17, 34, and 52
Achievement of LDL-C target grouped according to whether patients had achieved target at the start of this extension study
Time frame: Week 52
Adverse events and laboratory test changes
Time frame: Weeks 17, 34, and 52
Achievement of LDL-C target
Time frame: Weeks 17 and 34
Achievement of LDL-C target by diabetic patients
Time frame: Week 52
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
15 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 15 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 2 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 15 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?
Achievement of low-density lipoprotein cholesterol (LDL-C) target of <115 mg/dL (time frame: Week 52). 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.