JRCT ID: jRCT2051240110
Registered date:20/08/2024
Open-label Extension Study of MK-0616 in Adults With Hypercholesterolemia
Basic Information
Recruitment status | Pending |
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Health condition(s) or Problem(s) studied | Hypercholesterolemia |
Date of first enrollment | 01/10/2024 |
Target sample size | 3000 |
Countries of recruitment | USA,Japan,Argentina,Japan,Australia,Japan,Brazil,Japan,Canada,Japan,Chile,Japan,China,Japan,Columbia,Japan,Czech Republic,Japan,Finland,Japan,France,Japan,Germany,Japan,Hong Kong,Japan,Hungary,Japan,Israel,Japan,Italy,Japan,Mexico,Japan,Netherlands,Japan,New Zealand,Japan,Norway,Japan,South Africa,Japan,Singapore,Japan,South Korea,Japan,Spain,Japan,Taiwan,Japan,Turkey,Japan,UK,Japan |
Study type | Interventional |
Intervention(s) | Experimental: MK-0616 Participants will receive 20 mg of MK-0616 orally once daily (QD) |
Outcome(s)
Primary Outcome | -Number of participants with one or more adverse events (AEs) -Number of participants who discontinue study drug due to an AE |
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Secondary Outcome | -Mean percent change from baseline of the parent study in LDL-C at Week 8 of this extension study -Mean percent change from baseline of the parent study in non-HDL-C at Week 8 of this Extension Study -Mean percent change from baseline of the parent study in ApoB at Week 8 of this extension study -Percent change from baseline of the parent study in Lp(a) at Week 8 of this extension study -Percentage of participants with LDL-C <70 mg/dL and >=50% reduction from baseline of the parent study -Percentage of participants with LDL-C <55 mg/dL and >=50% reduction from baseline of the parent study |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | -Has completed a MK-0616 parent study (MK-0616-013, MK-0616-017, and MK-0616-018) per protocol (including the final assessments/procedures of their parent study) -Had an overall study intervention compliance >=80% while participating in their parent study |
Exclude criteria | -Has discontinued study intervention in their parent study -Has an ongoing serious adverse event considered related to study intervention by the investigator in the parent study -Is currently participating in an interventional clinical study other than an MK-0616 parent study |
Related Information
Primary Sponsor | Kobayashi Masayuki |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | NCT06492291 |
Contact
Public contact | |
Name | mailbox inquiry MSDJRCT |
Address | KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan Tokyo Japan 102-8667 |
Telephone | +81-3-6272-1957 |
msdjrct@merck.com | |
Affiliation | MSD K.K. |
Scientific contact | |
Name | Masayuki Kobayashi |
Address | KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan Tokyo Japan 102-8667 |
Telephone | +81-3-6272-1957 |
msdjrct@merck.com | |
Affiliation | MSD K.K. |