Lipitor Korean Atorvastatin Goal Achievement Across Risk Levels Study

NCT00540293 | Completed Phase 4 Results

• 1 other identifier: A2581157
• Study Type: interventional
• Target: 425
• Locations: 1 country
• Sites: 20

Brief 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.

Conditions

Dyslipidemias

Outcome Measures

Primary Outcomes (1)

• 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)

  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.

  Week 4

• Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment

  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

  weeks 4 and 8

• Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin.

  8 weeks

• Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin.

  8 weeks

Study Arms (1)

Treatment group

EXPERIMENTAL

this patient group consists of dyslipidemia patients with various CVD risk factors

Drug: Atorvastatin

Interventions

Atorvastatin DRUG

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

Treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (20)

Pfizer Investigational Site

Daegu, Korea, 705-717, South Korea

Location

Pfizer Investigational Site

Seoul, Korea, 135-710, South Korea

Location

Pfizer Investigational Site

Busan, 602-739, South Korea

Location

Pfizer Investigational Site

Busan, 614-735, South Korea

Location

Pfizer Investigational Site

Daegu, 700-712, South Korea

Location

Pfizer Investigational Site

Daejeon, 302-718, South Korea

Location

Pfizer Investigational Site

Gwangju, 501-757, South Korea

Location

Pfizer Investigational Site

Gwangju, 503-715, South Korea

Location

Pfizer Investigational Site

Gyeonggi-do, 431-070, South Korea

Location

Pfizer Investigational Site

Gyeonggi-do, 463-707, South Korea

Location

Pfizer Investigational Site

Incheon, 405-760, South Korea

Location

Pfizer Investigational Site

Kyunggi-do, 420-717, South Korea

Location

Pfizer Investigational Site

Seoul, 110-744, South Korea

Location

Pfizer Investigational Site

Seoul, 110-746, South Korea

Location

Pfizer Investigational Site

Seoul, 120-752, South Korea

Location

Pfizer Investigational Site

Seoul, 134-010, South Korea

Location

Pfizer Investigational Site

Seoul, 136-705, South Korea

Location

Pfizer Investigational Site

Seoul, 137-701, South Korea

Location

Pfizer Investigational Site

Seoul, 138-736, South Korea

Location

Pfizer Investigational Site

Seoul, 143-914, South Korea

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Dyslipidemias

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2007
• First Posted: October 8, 2007
• Study Start: October 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: March 12, 2021
• Results First Posted: June 26, 2009

Record last verified: 2021-02

Locations

KR (20)