DyslipidemiasPhase 4NCT00647543
Atorvastatin Study For The Treatment Of High Cholesterol In Patients From Thailand
A Phase 4 study testing Atorvastatin in people with Dyslipidemias, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 4 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the efficacy of atorvastatin in lowering cholesterol on patients from Thailand with high cholesterol. Read more about this study
- Who is it for?
- Ages 18 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
- 242 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Aug 2003to Apr 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dyslipidemic patients who were eligible for lipid lowering therapy
- Willingness to follow study diet for 1 month prior to screening and for the duration of the study
Who cannot join
- Use of other lipid lowering agents (6-week washout period)
- Uncontrolled high blood pressure
- Impaired liver function
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Thailand3 sites
Pfizer Investigational Site
Bangkok, 10400
Pfizer Investigational Site
Bangkok, 10700
Pfizer Investigational Site
Chiang Mai, 50200
Location not given1 site
Pfizer Investigational Site
About this study
Official title: A Multicenter, Eight-Week Treatment, Single-Step Titration, Open-Label Study Assessing The Percentage Of Dyslipidemic Patients Achieving LDL Cholesterol Target With Atorvastatin Starting Doses Of 10 Mg, 20 Mg, And 40 Mg
The purpose of this study is to evaluate the efficacy of atorvastatin in lowering cholesterol on patients from Thailand with high cholesterol.
- 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, or 40 mg once daily for at least 8 weeks. Patients who achieved their LDL-C target by Week 4 continued on their starting dose for the next 4 weeks. Patients who did not achieve their LDL-C target by Week 4 were titrated up 1 dose step for the next 4 weeks.
AtorvastatinDrug
Atorvastatin tablets at starting doses of 10, 20, or 40 mg once daily for at least 8 weeks. Patients who achieved their LDL-C target by Week 4 continued on their starting dose for the next 4 weeks. Patients who did not achieve their LDL-C target by Week 4 were titrated up 1 dose step for the next 4 weeks.
AtorvastatinDrug
Atorvastatin tablets at starting doses of 10, 20, or 40 mg once daily for at least 8 weeks. Patients who achieved their LDL-C target by Week 4 continued on their starting dose for the next 4 weeks. Patients who did not achieve their LDL-C target by Week 4 were titrated up 1 dose step for the next 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| High Risk | Experimental | Not described Receives: Drug: Atorvastatin |
| Low Risk | Experimental | Not described Receives: Drug: Atorvastatin |
| Medium Risk | 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 patients who achieved low-density lipoprotein cholesterol (LDL-C) target
Measured: Week 8
Secondary outcomes (7)
Adverse events and laboratory test changes
Measured: Weeks 2, 4, and 8
Percentage of patients who achieved LDL-C target
Measured: Weeks 2 and 4, and Week 8 with 1 step titration
Change and percent change from baseline in LDL-C
Measured: Weeks 2, 4, and 8
Change and percent change from baseline in high-density lipoprotein cholesterol (HDL-C)
Measured: Weeks 2, 4, and 8
Change and percent change from baseline in LDL/HDL ratio
Measured: Weeks 2, 4, and 8
Change and percent change from baseline in total cholesterol
Measured: Weeks 2, 4, and 8
Change and percent change from baseline in triglycerides
Measured: Weeks 2, 4, and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2008 (estimated)
- Study startAug 2003
- Study completionApr 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 242 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
- NCT00647543
- Sponsor's protocol ID
- A2581111
- Status last verified
- Feb 2021
- First submitted
- 26 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, Eight-Week Treatment, Single-Step Titration, Open-Label Study Assessing The Percentage Of Dyslipidemic Patients Achieving LDL Cholesterol Target With Atorvastatin Starting Doses Of 10 Mg, 20 Mg, And 40 Mg
- ClinicalTrials.gov ID
- NCT00647543
- Acronym / sponsor ID
- A2581111
- Conditions
- Dyslipidemias
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2003
- Study completion
- Apr 2004 (actual)
- First posted
- 31 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 this study is to evaluate the efficacy of atorvastatin in lowering cholesterol on patients from Thailand with high cholesterol.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Risk | Experimental | Drug: Atorvastatin |
| Low Risk | Experimental | Drug: Atorvastatin |
| Medium Risk | Experimental | Drug: Atorvastatin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Dyslipidemic patients who were eligible for lipid lowering therapy
- Willingness to follow study diet for 1 month prior to screening and for the duration of the study
Key exclusion criteria (3 listed)
- Use of other lipid lowering agents (6-week washout period)
- Uncontrolled 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 |
|---|---|---|
| AtorvastatinAtorvastatin tablets at starting doses of 10, 20, or 40 mg once daily for at least 8 weeks. Patients who achieved their LDL-C target by Week 4 continued on their starting dose for the next 4 weeks. Patients who did not achieve their LDL-C target by Week 4 were titrated up 1 dose step for the next 4 weeks. | Drug | High Risk |
| AtorvastatinAtorvastatin tablets at starting doses of 10, 20, or 40 mg once daily for at least 8 weeks. Patients who achieved their LDL-C target by Week 4 continued on their starting dose for the next 4 weeks. Patients who did not achieve their LDL-C target by Week 4 were titrated up 1 dose step for the next 4 weeks. | Drug | Low Risk |
| AtorvastatinAtorvastatin tablets at starting doses of 10, 20, or 40 mg once daily for at least 8 weeks. Patients who achieved their LDL-C target by Week 4 continued on their starting dose for the next 4 weeks. Patients who did not achieve their LDL-C target by Week 4 were titrated up 1 dose step for the next 4 weeks. | Drug | Medium Risk |
Primary outcome
Percentage of patients who achieved low-density lipoprotein cholesterol (LDL-C) target
Time frame: Week 8
7 secondary outcomes
Adverse events and laboratory test changes
Time frame: Weeks 2, 4, and 8
Percentage of patients who achieved LDL-C target
Time frame: Weeks 2 and 4, and Week 8 with 1 step titration
Change and percent change from baseline in LDL-C
Time frame: Weeks 2, 4, and 8
Change and percent change from baseline in high-density lipoprotein cholesterol (HDL-C)
Time frame: Weeks 2, 4, and 8
Change and percent change from baseline in LDL/HDL ratio
Time frame: Weeks 2, 4, and 8
Change and percent change from baseline in total cholesterol
Time frame: Weeks 2, 4, and 8
Change and percent change from baseline in triglycerides
Time frame: Weeks 2, 4, and 8
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
4 sites in 2 countries: 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 4 sites in 2 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 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 4 sites in Thailand. 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 patients who achieved low-density lipoprotein cholesterol (LDL-C) target (time frame: Week 8). 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; AzTrials last refreshed its copy on 8 Nov 2026.