Lipitor Korean Atorvastatin Goal Achievement Across Risk Levels Study - Study Results

Lipitor Korean Atorvastatin Goal Achievement Across Risk Levels Study (AT GOAL)

This study has been completed.

Study NCT00540293 Information provided by Pfizer

First Received on October 4, 2007. Last Updated on August 14, 2009 History of Changes

Results First Received: May 8, 2009

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Dyslipidemias
Intervention:	Drug: Atorvastatin

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study was conducted at 20 centers in Korea

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants who were on antilipidemic medications at the time of screening required a 6-week washout period prior to study treatment

Reporting Groups

	Description
Total Treatment Group (All Subjects Who Received Atorvastatin)	this patient group consists of dyslipidemia patients with various cardiovascular diseases (CVD)risk factors

Participant Flow: Overall Study

	Total Treatment Group (All Subjects Who Received Atorvastatin)
STARTED	425
COMPLETED	390
NOT COMPLETED	35
Adverse event related to study drug	10
Adverse event not related to study drug	7
Withdrawal by Subject	6
Protocol violation, & subject schedule	12

Baseline Characteristics

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Reporting Groups

	Description
Total Treatment Group (All Subjects Who Received Atorvastatin)	this patient group consists of dyslipidemia patients with various cardiovascular diseases (CVD)risk factors

Baseline Measures

	Total Treatment Group (All Subjects Who Received Atorvastatin)
Number of Participants [units: participants]	425
Age [units: Years] Mean ± Standard Deviation
Females between 18 and 80 years	62.9 ± 8.6
Males between 18 and 80 years	58.6 ± 10.2
Gender [units: participants]
Female	195
Male	230

Outcome Measures

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1. Primary:

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 ]

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2. Secondary:

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 ]

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3. Secondary:

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 ]

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4. Secondary:

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 ]

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5. Secondary:

Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. [ Time Frame: 8 weeks ]

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6. Secondary:

Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. [ Time Frame: 8 weeks ]

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7. Secondary:

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 ]

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8. Secondary:

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 ]

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9. Secondary:

Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. [ Time Frame: Baseline, and 8 weeks ]

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10. Secondary:

Percent Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. [ Time Frame: 8 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of <60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), <12 mo from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00540293 History of Changes
Other Study ID Numbers:	A2581157
Study First Received:	October 4, 2007
Results First Received:	May 8, 2009
Last Updated:	August 14, 2009
Health Authority:	Korea: Institutional Review Board