A Long-term Trial of ETC-1002 in Patients With Hyper-LDL Cholesterolemia (NCT05687071) | Clinical Trial Compass
CompletedPhase 3
A Long-term Trial of ETC-1002 in Patients With Hyper-LDL Cholesterolemia
Japan130 participantsStarted 2023-02-27
Plain-language summary
A Multicenter, Open-label Study to assess the safety and efficacy of ETC-1002 at 180 mg administered for 52 weeks in patients with hyper-LDL cholesterolemia
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with inadequate response to statins or who have difficulty in treatment with statins as defined below \[Inadequate response to statins\] Patients with hyper-LDL cholesterolemia who are currently taking or have previously taken statins\[and other lipid-modifying therapies(LMTs) if needed\] and cannot achieve the lipid management goals of LDL-C \[Difficulty in treatment with statins\] Patients with hyper-LDL cholesterolemia for whom safety problems have occurred while taking at least one type of statin, and who experienced resolution of the problems after discontinuation or dose reduction, or of those patients who have a history of statin administration and who are judged to have concerns of safety problems associated with the administration or dose increase of statins and who cannot achieve the lipid management goals of LDL-C. Patients must be on the lowest or under the dosage of the approved dose of statin and/or on stable LMT(s).
* Patients with fasting TG levels of \<400 mg/dL at screening
* Other protocol specific inclusion criteria may apply
Exclusion Criteria:
* Females who are pregnant or breast-feeding or who have a positive pregnancy test (urine) result at screening or baseline visits
* Patients with homozygous familial hypercholesterolemia (HoFH)
* Patients who currently have or who have had within the past 3 months prior to screening any cardiovascular diseases, or those who have developed any cardiovascular diseases during the scre…
What they're measuring
1
Number of Subjects Experiencing Treatment-Emergent Adverse Events (TEAEs)
Timeframe: From baseline to week 52
2
Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 52