A Study of the Safety and Efficacy of Anacetrapib (MK-0859) When Added to Ongoing Statin Therapy in Japanese Participants With Dyslipidemia (MK-0859-051 AM1)
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|ClinicalTrials.gov Identifier: NCT01760460|
Recruitment Status : Completed
First Posted : January 4, 2013
Last Update Posted : June 1, 2017
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
This study will evaluate the effects of anacetrapib (MK-0859) on low-density lipoprotein-cholesterol (LDL-C) when compared to placebo in Japanese participants with dyslipidemia when added to an existing statin-modifying therapy.
|Condition or disease||Intervention/treatment||Phase|
|Dyslipidemia||Drug: Anacetrapib Drug: Placebo for anacetrapib||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||307 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Multicenter, 24-Week, Double-Blind, Randomized, Placebo-Controlled, Phase III Study With 28-Week Open Labeled Extension Period to Assess the Efficacy and Safety of MK-0859 When Added to Ongoing Statin Therapy With or Without Other Lipid Modifying Medication(s) in Japanese Patients With Dyslipidemia|
|Actual Study Start Date :||March 14, 2013|
|Primary Completion Date :||March 4, 2015|
|Study Completion Date :||March 4, 2015|
Participants will receive 100-mg anacetrapib, orally, once-daily for 24 weeks. Participants will continue on once-daily 100-mg anacetrapib during 28 week open-label extension.
Other Name: MK-0859
Placebo Comparator: Placebo
Participants will receive placebo tablet, orally, once daily for 24 weeks. Participants will be switched to once-daily 100-mg anacetrapib during 28 week open-label extension.
|Drug: Placebo for anacetrapib|
Primary Outcome Measures :
- Percent Change from Baseline in LDL-C (beta-quantification [BQ] method) [ Time Frame: Baseline and Week 24 ]
- Percentage of Participants who Experience at Least One Adverse Event (AE) [ Time Frame: 64 weeks ]
Secondary Outcome Measures :
- Percent Change from Baseline in High-density Lipoprotein-cholesterol (HDL-C) [ Time Frame: Baseline and Week 24 ]
- Percent Change from Baseline in Non-HDL-C [ Time Frame: Baseline and Week 24 ]
- Percent Change from Baseline in Apolipoprotein B (Apo-B) [ Time Frame: Baseline and Week 24 ]
- Percent Change from Baseline in Apolipoprotein A-I (Apo-A-I) [ Time Frame: Baseline and Week 24 ]
- Percent Change from Baseline in Lipoprotein(a) (Lp[a]) [ Time Frame: Baseline and Week 24 ]
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