DyslipidemiasPhase 4AT GOALNCT00540293

Lipitor Korean Atorvastatin Goal Achievement Across Risk Levels Study

A Phase 4 study testing Atorvastatin in people with Dyslipidemias, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 20 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate the percentage of Korean dyslipidemic subjects in the total group and each cardiovascular risk group achieving LDL-C target as defined by NCEP ATP Ⅲ criteria at starting doses of 10mg, 20mg and 40mg of atorvastatin after 8 weeks of 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
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 425 participants
Where: 20 sitesSouth Korea
Study dates: Oct 2007to May 2008
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Is a Korean , dyslipidemic outpatient
Is eligible for LDL-lowering drug therapy at screening and baseline as determined by the following LDL-cholesterol (LDL-C) cut-off points defined by NCEP ATP Ⅲ: 2. 1 LDL-C ≥ 190 mg/dL for subjects with 0 or 1 CHD risk factor 2. 2 LDL-C ≥ 160 mg/dL for subjects with 2 or more CHD risk factors and 10 year risk < 10 % 2. 3 LDL-C ≥ 130 mg/dL for subjects with 2 or more CHD risk factors and 10 year risk 10-20 % 2. 4 LDL-C ≥ 100 mg/dL for subjects with documented CHD or CHD risk equivalents (10-year risk > 20 %)
Has LDL-C ≤ 220mg/dL at baseline 4. Has triglyceride level ≤ 600mg/dL at baseline

Who cannot join

Is pregnant or lactating
Has present myopathy or history of myopathy or has personal or familial history of hereditary muscular disorders or any history of rhabdomyolysis
Has history of intolerance or hypersensitivity to atorvastatin or other statins
Uncontrolled hypertension (i.e. moderate hypertension, sitting systolic BP ≥ 160mmHg and/or diastolic BP ≥ 100mmHg)
Has HbAlc > 10%
Has any severe disease of has had any major problem or surgical procedure within the 3 months prior to screening that is likely to jeopardize the planned termination of the study. (e.g., any carcinoma, coronary angioplasty, coronary artery bypass graft, cardiac infarct, severe or unstable angina pectoris)

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

South Korea20 sites

Pfizer Investigational Site
Busan, 602-739
Pfizer Investigational Site
Busan, 614-735
Pfizer Investigational Site
Daegu, Korea, 705-717
Pfizer Investigational Site
Daegu, 700-712
Pfizer Investigational Site
Daejeon, 302-718
Pfizer Investigational Site
Gwangju, 501-757
Pfizer Investigational Site
Gwangju, 503-715
Pfizer Investigational Site
Gyeonggi-do, 431-070
Pfizer Investigational Site
Gyeonggi-do, 463-707
Pfizer Investigational Site
Incheon, 405-760
Pfizer Investigational Site
Kyunggi-do, 420-717
Pfizer Investigational Site
Seoul, Korea, 135-710
Pfizer Investigational Site
Seoul, 110-744
Pfizer Investigational Site
Seoul, 110-746
Pfizer Investigational Site
Seoul, 120-752
Pfizer Investigational Site
Seoul, 134-010
Pfizer Investigational Site
Seoul, 136-705
Pfizer Investigational Site
Seoul, 137-701
Pfizer Investigational Site
Seoul, 138-736
Pfizer Investigational Site
Seoul, 143-914

Other trials in South Korea

About this study

Official title: A Multicenter, Eight-Week Treatment, Single-Step Titration Open-Label Study Assessing The Percentage Of Korean Dyslipidemic Patients Achieving LDL Cholesterol Target With Atorvastatin Starting Doses Of 10 MG, 20 MG, And 40 MG.

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
Prescription of 10/20/40mg dose atorvastatin based on the personal risk factor that is defined in the NCEP ATP III guideline in a single patient group

Study groups in NCT00540293
Study group	Role	What they receive
Treatment group	Experimental	this patient group consists of dyslipidemia patients with various CVD risk factors Receives: Drug: Atorvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent of Subjects in the Total and Each Cardiovascular Risk Group Achieving Low Density Lipoprotein-cholesterol (LDL-C) Target After 8 Weeks of Treatment.
LDL-C Responders by visit and by risk group - full analysis set (FAS)
Measured: Week 8

Secondary outcomes (9)

Percent of Subjects in the Total Group and Each Cardiovascular Risk Group Achieving LDL-C Target After 4 Weeks of Treatment.
LDL-C Responders by visit and by risk group - FAS
Measured: Week 4
Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment
Mean baseline, change and percent change from baseline in lipid parameters by risk group - FAS. HDL-C: high density lipoprotein-cholesterol; TC: total cholesterol; TG: triglyceride
Measured: Weeks 4 and 8
Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment
Mean percent changes from baseline in lipid parameters by risk group - FAS. HDL-C: high density lipoprotein-cholesterol; TC: total cholesterol; TG: triglyceride
Measured: weeks 4 and 8
Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin.
LDL-C responders at week 8 by titration status and risk groups - FAS, efficacy evaluation (EVAL), and FAS (no last observation carried forward, LOCF)
Measured: 8 weeks
Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin.
LDL-C responders at week 8 by titration status and risk groups - FAS, efficay evaluation (EVAL), and FAS (no last observation carried forward, LOCF)
Measured: 8 weeks
Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment
Median baseline, and change from baseline in hs-CRP by risk group - FAS
Measured: 4 and 8 weeks
Percent Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment
Percent change from baseline in hs-CRP by risk group - FAS
Measured: 4 and 8 weeks
Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment.
Median baseline, and change from baseline in monocyte chemoattractant protein (MCP-1), interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha) by risk group - FAS
Measured: Baseline, and 8 weeks
Percent Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment.
Percent changes from baseline in monocyte chemoattractant protein (MCP-1), interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha) by risk group - FAS
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2007May 2008

First posted8 Oct 2007 (estimated)
Study startOct 2007
Primary completionMay 2008
Study completionMay 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: 425 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00540293
Sponsor's protocol ID: A2581157
Acronym: AT GOAL
Status last verified: Feb 2021
First submitted: 4 Oct 2007
Last updated: 12 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease

All Dyslipidemias trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 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 Korean Dyslipidemic Patients Achieving LDL Cholesterol Target With Atorvastatin Starting Doses Of 10 MG, 20 MG, And 40 MG.
ClinicalTrials.gov ID: NCT00540293
Acronym / sponsor ID: AT GOAL / A2581157
Conditions: Dyslipidemias
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 425 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Oct 2007
Primary completion: May 2008 (actual)
Study completion: May 2008 (actual)
First posted: 8 Oct 2007 (estimated)
Results: Posted 26 Jun 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment group	Experimental	Drug: Atorvastatinthis patient group consists of dyslipidemia patients with various CVD risk factors

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Is a Korean , dyslipidemic outpatient
Is eligible for LDL-lowering drug therapy at screening and baseline as determined by the following LDL-cholesterol (LDL-C) cut-off points defined by NCEP ATP Ⅲ: 2. 1 LDL-C ≥ 190 mg/dL for subjects with 0 or 1 CHD risk factor 2. 2 LDL-C ≥ 160 mg/dL for subjects with 2 or more CHD risk factors and 10 year risk < 10 % 2. 3 LDL-C ≥ 130 mg/dL for subjects with 2 or more CHD risk factors and 10 year risk 10-20 % 2. 4 LDL-C ≥ 100 mg/dL for subjects with documented CHD or CHD risk equivalents (10-year risk > 20 %)
Has LDL-C ≤ 220mg/dL at baseline 4. Has triglyceride level ≤ 600mg/dL at baseline

Key exclusion criteria (6 listed)

Is pregnant or lactating
Has present myopathy or history of myopathy or has personal or familial history of hereditary muscular disorders or any history of rhabdomyolysis
Has history of intolerance or hypersensitivity to atorvastatin or other statins
Uncontrolled hypertension (i.e. moderate hypertension, sitting systolic BP ≥ 160mmHg and/or diastolic BP ≥ 100mmHg)
Has HbAlc > 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
AtorvastatinPrescription of 10/20/40mg dose atorvastatin based on the personal risk factor that is defined in the NCEP ATP III guideline in a single patient group	Drug	Treatment group

Primary outcome

Percent of Subjects in the Total and Each Cardiovascular Risk Group Achieving Low Density Lipoprotein-cholesterol (LDL-C) Target After 8 Weeks of Treatment.
Time frame: Week 8
LDL-C Responders by visit and by risk group - full analysis set (FAS)

9 secondary outcomes

Percent of Subjects in the Total Group and Each Cardiovascular Risk Group Achieving LDL-C Target After 4 Weeks of Treatment.
Time frame: Week 4
Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment
Time frame: Weeks 4 and 8
Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment
Time frame: weeks 4 and 8
Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin.
Time frame: 8 weeks
Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin.
Time frame: 8 weeks
Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment
Time frame: 4 and 8 weeks
Percent Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment
Time frame: 4 and 8 weeks
Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment.
Time frame: Baseline, and 8 weeks
Percent Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment.
Time frame: 8 weeks

Results and safety

Results posted to the registry on 26 Jun 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Total Treatment Group (All Subjects Who Received Atorvastatin)	425	390

Primary outcome: Percent of Subjects in the Total and Each Cardiovascular Risk Group Achieving Low Density Lipoprotein-cholesterol (LDL-C) Target After 8 Weeks of Treatment.

Time frame: Week 8. Mean (95% Confidence Interval). Unit: Percentage of participants

Measure	Total n = 415	Low Risk n = 28	Medium Risk n = 44	High Risk n = 343
Value	86.0 (82.3 to 89.2)	92.9 (76.5 to 99.1)	95.5 (84.5 to 99.4)	84.3 (80.0 to 87.9)

Population analysed: N=number of subjects in the Full Analysis Set (FAS). Number of Participants Analyzed represents subjects with on-treatment lipid measures (missing values imputed by last observation carried forward)

9 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Total Treatment Group (All Subjects Who Received Atorvastatin)	3 of ?	14 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Dyslipidemias

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease

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 4 study testing Atorvastatin in people with Dyslipidemias, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 20 sites in South Korea.

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 6 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 12 Mar 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 South Korea. 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?

Yes. Results are posted in the registry (first posted 26 Jun 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percent of Subjects in the Total and Each Cardiovascular Risk Group Achieving Low Density Lipoprotein-cholesterol (LDL-C) Target After 8 Weeks of Treatment. (time frame: Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00540293.

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 12 Mar 2021.