Livalo Acute Myocardial Infarction Study (LAMIS)
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ClinicalTrials.gov Identifier: NCT01265706 |
Recruitment Status
:
Completed
First Posted
: December 23, 2010
Last Update Posted
: December 15, 2014
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Sponsor:
JW Pharmaceutical
Information provided by (Responsible Party):
JW Pharmaceutical
Tracking Information | ||||
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First Submitted Date | October 18, 2010 | |||
First Posted Date | December 23, 2010 | |||
Last Update Posted Date | December 15, 2014 | |||
Study Start Date | July 2010 | |||
Actual Primary Completion Date | May 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
Incidence of TLR-MACE for 1 year after enrollment [ Time Frame: 1 year after enrollment ] | |||
Original Primary Outcome Measures | Not Provided | |||
Change History | Complete list of historical versions of study NCT01265706 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures |
Incidence of TVR-MACE for 1 year after enrollment [ Time Frame: 1 year after enrollment ] | |||
Original Secondary Outcome Measures | Not Provided | |||
Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Livalo Acute Myocardial Infarction Study (LAMIS) | |||
Official Title | 1-year, Prospective, Randomized, Open-label, Parallel Group Observational Study to Evaluate the Safety and Efficacy of 4mg/Day of Pitavastatin Versus 2mg/Day of Pitavastatin in Acute Myocardial Infarction(AMI) | |||
Brief Summary | This study is performed to observe the incidence of major cardiovascular events in Korean patients with AMI after giving pitavastatin 2mg and 4mg longer than 1 year. | |||
Detailed Description | Not Provided | |||
Study Type | Observational | |||
Study Design | Time Perspective: Prospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Probability Sample | |||
Study Population | AMI patients who are in need to be treated by statins | |||
Condition | Acute Myocardial Infarction | |||
Intervention | Not Provided | |||
Study Groups/Cohorts | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Estimated Enrollment |
1000 | |||
Original Estimated Enrollment | Same as current | |||
Actual Study Completion Date | December 2014 | |||
Actual Primary Completion Date | May 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | Child, Adult, Senior | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Korea, Republic of | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01265706 | |||
Other Study ID Numbers | PTV_LAMIS II | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | JW Pharmaceutical | |||
Study Sponsor | JW Pharmaceutical | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | JW Pharmaceutical | |||
Verification Date | December 2014 |