Open-label Extension Study of MK-0616 in Adults With Hypercholesterolemia

JRCT ID: jRCT2051240110

Registered date:20/08/2024

Basic Information

• Recruitment status: Pending
• 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

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
• 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
• Secondary ID(s): NCT06492291