A Phase 3, Open-label Extension Study to Evaluate the Safety and Efficacy of MK-0616 in Adults With Hypercholesterolemia

Conditions

Hypercholesterolemia

Brief summary

Number of participants with one or more adverse events (AEs), Number of participants who discontinue study drug due to an AE

Detailed description

Percent change from baseline of the parent study in low-density lipoprotein cholesterol (LDL-C) at Week 8 of this extension study, Percent change from baseline of the parent study in non-high-density lipoprotein cholesterol (non-HDL-C) at Week 8 of this extension study, Percent change from baseline of the parent study in apolipoprotein B (ApoB) at Week 8 of this extension study, Percent change from baseline of the parent study in lipoprotein(a) (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

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGMK-0616

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Number of participants with one or more adverse events (AEs), Number of participants who discontinue study drug due to an AE	—

Secondary

Measure	Time frame
Percent change from baseline of the parent study in low-density lipoprotein cholesterol (LDL-C) at Week 8 of this extension study, Percent change from baseline of the parent study in non-high-density lipoprotein cholesterol (non-HDL-C) at Week 8 of this extension study, Percent change from baseline of the parent study in apolipoprotein B (ApoB) at Week 8 of this extension study, Percent change from baseline of the parent study in lipoprotein(a) (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	—

Measure

Time frame

Percent change from baseline of the parent study in low-density lipoprotein cholesterol (LDL-C) at Week 8 of this extension study, Percent change from baseline of the parent study in non-high-density lipoprotein cholesterol (non-HDL-C) at Week 8 of this extension study, Percent change from baseline of the parent study in apolipoprotein B (ApoB) at Week 8 of this extension study, Percent change from baseline of the parent study in lipoprotein(a) (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

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Countries

Czechia, Finland, France, Germany, Hungary, Italy, Netherlands, Norway, Spain

Outcome results

None listed