The Effect of MK0859 on Lipoprotein Metabolism in Patients With Dyslipidemia (0859-026 AM3)
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ClinicalTrials.gov Identifier: NCT00990808 |
Recruitment Status
:
Completed
First Posted
: October 7, 2009
Last Update Posted
: June 4, 2015
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Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
Tracking Information | ||||
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First Submitted Date ICMJE | October 6, 2009 | |||
First Posted Date ICMJE | October 7, 2009 | |||
Last Update Posted Date | June 4, 2015 | |||
Study Start Date ICMJE | November 2009 | |||
Actual Primary Completion Date | June 2011 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Difference in Production Rate (PR) and Fractional Catabolic Rate (FCR) of Low Density Lipoprotein (LDL) apoB100 following treatment with MK0859 and atorvastatin versus atorvastatin alone [ Time Frame: 12 weeks ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT00990808 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Difference in FCR of LDL apoB100 following treatment with MK0859 versus placebo [ Time Frame: 12 weeks ] | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | The Effect of MK0859 on Lipoprotein Metabolism in Patients With Dyslipidemia (0859-026 AM3) | |||
Official Title ICMJE | A Multiple Dose Study to Investigate the Effect of MK0859 on Lipoprotein Metabolism When Added to Ongoing Statin Therapy in Dyslipidemic Patients | |||
Brief Summary | This study will investigate the effect of MK0859 on lipoprotein metabolism in patients with dyslipidemia already on statin therapy. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Dyslipidemia | |||
Intervention ICMJE |
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Study Arms |
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Publications * |
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* 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 ICMJE | Completed | |||
Actual Enrollment ICMJE |
46 | |||
Original Estimated Enrollment ICMJE |
40 | |||
Actual Study Completion Date | July 2011 | |||
Actual Primary Completion Date | June 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria :
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Sex/Gender |
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Ages | 18 Years to 70 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | United States | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00990808 | |||
Other Study ID Numbers ICMJE | 0859-026 0859-026 |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Merck Sharp & Dohme Corp. | |||
Study Sponsor ICMJE | Merck Sharp & Dohme Corp. | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Merck Sharp & Dohme Corp. | |||
Verification Date | June 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |