Hyper-low-density Lipoprotein (LDL) Cholesterolemia
Conditions
Brief 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
Interventions
180mg, tablet, once daily, for 52 weeks
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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 screening * Uncontrolled hypertension, defined as sitting systolic blood pressure after resting 5 minutes of ≥160 mmHg or diastolic blood pressure of ≥100 mmHg at screening * Patients with uncontrolled and serious hematologic or coagulation disorders or with hemoglobin of \<10.0 g/dL at screening * Patients with uncontrolled diabetes with HbA1c of ≥9% at screening * Patients with uncontrolled hypothyroidism with thyroid-stimulating hormone (TSH) of \>1.5 × ULN at screening * Patients with liver disease or dysfunction, including: * Positive serology for hepatitis B surface antigen (HBsAg) or a positive hepatitis C virus (HCV) antibody test at screening * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) of ≥3 × ULN or total bilirubin of ≥2 × ULN at screening * Patients with creatine kinase (CK) of \>3 × ULN at screening * Patients with a history or current renal dysfunction, nephritic syndrome, or nephritis, and with estimated glomerular filtration rate (eGFR) of ≤30 mL/min/1.73 m2 at screening * Other protocol specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Experiencing Treatment-Emergent Adverse Events (TEAEs) | From baseline to week 52 | — |
| Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 52 | Baseline, week52 | Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Non-HDL Cholesterol From Baseline to Week 52 | Baseline, week52 | Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. |
| Percent Change in Total Cholesterol From Baseline to Week 52 | Baseline, week52 | Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. |
| Percent Change in Apolipoprotein B From Baseline to Week 52 | Baseline, week52 | Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. |
| Percent Change in High Sensitivity C Reactive Protein From Baseline to Week 52 | Baseline, week52 | Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. |
| Percent Change in Hemoglobin A1c From Baseline to Week 52 | Baseline, week52 | Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. |
| Proportion of Subjects Whose LDL-C Value Achieved the Lipid Management Goals Based on Risk Assessment at Week 52 | Baseline, week52 | The proportion of subjects whose LDL-C value achieves the lipid management goal at Week 52. |
Countries
Japan
Contacts
STUDY_DIRECTORTakehisa Matsumaru
Otsuka Pharmaceutical Co., Ltd.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 62.0 years STANDARD_DEVIATION 11.72 |
| Age, Customized >=65 and <75 years | 41 Participants |
| Age, Customized <65 years | 72 Participants |
| Age, Customized >=75 years | 17 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 130 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Japan | 130 Participants |
| Sex: Female, Male Female | 56 Participants |
| Sex: Female, Male Male | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 130 |
| other Total, other adverse events | 73 / 130 |
| serious Total, serious adverse events | 8 / 130 |
Outcome results
None listed