DyslipidemiasPhase 4LA ATGOALNCT00645151
A Study Of The Efficacy Of Atorvastatin In Lowering Cholesterol In Latin American 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 33 sites in 8 countries.
Trial summary
The purpose of this study is to determine the percentage of patients who would reach a cholesterol goal after atorvastatin treatment. 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
- 512 participants
- Where
- 33 sitesin 8 countries
- Study dates
- Apr 2004to Feb 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with high cholesterol eligible for treatment with baseline LDL-C level of less than or equal to 220 mg/dL
- Willingness to follow diet
Who cannot join
- Triglycerides less than or equal to 400 mg/dL
- Hemoglobin A1c >10%
Trial locations and contacts
33 sites in 8 countries.
33 sites in 8 countries
Brazil13 sites
Pfizer Investigational Site
Belo Horizonte, Minas Gerais
Pfizer Investigational Site
Campinas, São Paulo, 13012-000
Pfizer Investigational Site
Campinas, São Paulo, 13059-740
Pfizer Investigational Site
Curitiba, Paraná, 80540-010
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, 90035-170
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, 90610-000
Pfizer Investigational Site
Rio de Janeiro, 20550-030
Pfizer Investigational Site
São José, Santa Catarina, 88103-460
Pfizer Investigational Site
São José do Rio Preto, São Paulo, 15090-000
Pfizer Investigational Site
São Paulo, SP/Brazil, 04039-001
Pfizer Investigational Site
São Paulo, São Paulo, 01244-030
Pfizer Investigational Site
São Paulo, São Paulo, 04012-180
Pfizer Investigational Site
São Paulo, São Paulo
Mexico6 sites
Pfizer Investigational Site
Chihuahua City, 31238
Pfizer Investigational Site
Durango, 34300
Pfizer Investigational Site
Guadalajara, Jalisco, 44290
Pfizer Investigational Site
Monterrey, Nuevo León, 64060
Pfizer Investigational Site
Monterrey, Nuevo León, 64410
Pfizer Investigational Site
Zapopan, Jalisco, 45200
Colombia5 sites
Pfizer Investigational Site
Barranquilla
Pfizer Investigational Site
Bogota, Cundinamarca
Pfizer Investigational Site
Bogotá, Cundinamarca
Pfizer Investigational Site
Bogotá, C/marca
Pfizer Investigational Site
Cali, Valle
Venezuela5 sites
Pfizer Investigational Site
Caracas, Dtto Federal, 1061
Pfizer Investigational Site
Caracas, Dtto Federal, 1081
Pfizer Investigational Site
Caracas, Edo. Miranda, 1061
Pfizer Investigational Site
Caracas, 1020
Pfizer Investigational Site
Dtto. Federal, Miranda, 1020
About this study
Official title: A Multicenter, Eight-Week Treatment, Single Step Titration, Open-Label Study Assessing The Percentage Of Subjects Achieving Low Density Lipoprotein Cholesterol Target With Atorvastatin Starting Doses Of 10 Mg, 20 Mg, 40 Mg, And 80 Mg (Latin American Atorvastatin ATGOAL Study)
The purpose of this study is to determine the percentage of patients who would reach a cholesterol goal after atorvastatin treatment.
- 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 calcium 10, 20, 40, or 80 mg tablets (dose dependent on individual risk factors and baseline LDL-C level) once daily for 4 weeks. After 4 weeks of treatment, subjects who did not achieve the LDL-C target goal were up-titrated to 20, 40, or 80 mg and subjects who achieved their LDL-target goal remained on the same dose for the following 4 weeks.
AtorvastatinDrug
Atorvastatin calcium 10, 20, 40, or 80 mg tablets (dose dependent on individual risk factors and baseline LDL-C level) once daily for 4 weeks. After 4 weeks of treatment, subjects who did not achieve the LDL-C target goal were up-titrated to 20, 40, or 80 mg and subjects who achieved their LDL-target goal remained on the same dose for the following 4 weeks.
AtorvastatinDrug
Atorvastatin calcium 10, 20, 40, or 80 mg tablets (dose dependent on individual risk factors and baseline LDL-C level) once daily for 4 weeks. After 4 weeks of treatment, subjects who did not achieve the LDL-C target goal were up-titrated to 20, 40, or 80 mg and subjects who achieved their LDL-target goal remained on the same dose for the following 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.
Responder rate in patients who achieved low-density lipoprotein cholesterol (LDL-C) level
Measured: Week 8
Secondary outcomes (2)
Percentage of patients achieving LDL goal at 2 and 4 weeks
Measured: Weeks 2 and 4
Lipid changes at week 4 & 8
Measured: Weeks 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 posted27 Mar 2008 (estimated)
- Study startApr 2004
- Study completionFeb 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 512 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
- NCT00645151
- Sponsor's protocol ID
- A2581104
- Acronym
- LA ATGOAL
- 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, Eight-Week Treatment, Single Step Titration, Open-Label Study Assessing The Percentage Of Subjects Achieving Low Density Lipoprotein Cholesterol Target With Atorvastatin Starting Doses Of 10 Mg, 20 Mg, 40 Mg, And 80 Mg (Latin American Atorvastatin ATGOAL Study)
- ClinicalTrials.gov ID
- NCT00645151
- Acronym / sponsor ID
- LA ATGOAL / A2581104
- Conditions
- Dyslipidemias
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 512 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2004
- Study completion
- Feb 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.
The purpose of this study is to determine the percentage of patients who would reach a cholesterol goal after atorvastatin treatment.
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)
- Patients with high cholesterol eligible for treatment with baseline LDL-C level of less than or equal to 220 mg/dL
- Willingness to follow diet
Key exclusion criteria (2 listed)
- Triglycerides less than or equal to 400 mg/dL
- Hemoglobin A1c >10%
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 calcium 10, 20, 40, or 80 mg tablets (dose dependent on individual risk factors and baseline LDL-C level) once daily for 4 weeks. After 4 weeks of treatment, subjects who did not achieve the LDL-C target goal were up-titrated to 20, 40, or 80 mg and subjects who achieved their LDL-target goal remained on the same dose for the following 4 weeks. | Drug | High Risk |
| AtorvastatinAtorvastatin calcium 10, 20, 40, or 80 mg tablets (dose dependent on individual risk factors and baseline LDL-C level) once daily for 4 weeks. After 4 weeks of treatment, subjects who did not achieve the LDL-C target goal were up-titrated to 20, 40, or 80 mg and subjects who achieved their LDL-target goal remained on the same dose for the following 4 weeks. | Drug | Low Risk |
| AtorvastatinAtorvastatin calcium 10, 20, 40, or 80 mg tablets (dose dependent on individual risk factors and baseline LDL-C level) once daily for 4 weeks. After 4 weeks of treatment, subjects who did not achieve the LDL-C target goal were up-titrated to 20, 40, or 80 mg and subjects who achieved their LDL-target goal remained on the same dose for the following 4 weeks. | Drug | Medium Risk |
Primary outcome
Responder rate in patients who achieved low-density lipoprotein cholesterol (LDL-C) level
Time frame: Week 8
2 secondary outcomes
Percentage of patients achieving LDL goal at 2 and 4 weeks
Time frame: Weeks 2 and 4
Lipid changes at week 4 & 8
Time frame: Weeks 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
33 sites in 8 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 33 sites in 8 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 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 33 sites in Brazil, Mexico, Colombia, Venezuela, Chile and 3 more countries. 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?
Responder rate in patients who achieved low-density lipoprotein cholesterol (LDL-C) level (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.