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Lipitor Korean Atorvastatin Goal Achievement Across Risk Levels Study

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Daegu, Korea, 705-717 Korea, Republic of
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Dyslipidemias
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-80 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Is a Korean , dyslipidemic outpatient

2. 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 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 %)

3. Has LDL-C ≤ 220mg/dL at baseline 4. Has triglyceride level ≤ 600mg/dL at baseline

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

1. Is pregnant or lactating

2. Has present myopathy or history of myopathy or has personal or familial history of
hereditary muscular disorders or any history of rhabdomyolysis

3. Has history of intolerance or hypersensitivity to atorvastatin or other statins

4. Uncontrolled hypertension (i.e. moderate hypertension, sitting systolic BP ? 160mmHg
and/or diastolic BP ? 100mmHg)

5. Has HbAlc > 10%

6. 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)

NCT00540293
Pfizer
Completed
Lipitor Korean Atorvastatin Goal Achievement Across Risk Levels Study

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Lipitor Korean Atorvastatin Goal Achievement Across Risk Levels Study
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.
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 ? criteria at starting doses of 10mg, 20mg and 40mg of atorvastatin after 8 weeks of treatment.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Dyslipidemias
Drug: Atorvastatin
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
Experimental: Treatment group
this patient group consists of dyslipidemia patients with various CVD risk factors
Intervention: Drug: Atorvastatin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
425
May 2008
May 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Is a Korean , dyslipidemic outpatient
  2. 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 ?: 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 %)
  3. Has LDL-C ? 220mg/dL at baseline 4. Has triglyceride level ? 600mg/dL at baseline

Exclusion Criteria:

  1. Is pregnant or lactating
  2. Has present myopathy or history of myopathy or has personal or familial history of hereditary muscular disorders or any history of rhabdomyolysis
  3. Has history of intolerance or hypersensitivity to atorvastatin or other statins
  4. Uncontrolled hypertension (i.e. moderate hypertension, sitting systolic BP ? 160mmHg and/or diastolic BP ? 100mmHg)
  5. Has HbAlc > 10%
  6. 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)
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT00540293
A2581157
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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