NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2051240110

Registered date:20/08/2024

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

Basic Information

Recruitment status Pending
Health condition(s) or Problem(s) studiedHypercholesterolemia
Date of first enrollment01/10/2024
Target sample size3000
Countries of recruitmentUSA,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 typeInterventional
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 maximumNot applicable
GenderBoth
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

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
E-mail 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
E-mail msdjrct@merck.com
Affiliation MSD K.K.