Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04669041 | A Study to Evaluate the Efficacy and the Safety of Single Pill Combination (SPC) Ezetimibe/Rosuvastatin in Chinese Adult Patients With Primary Hypercholesterolemia Not Adequately Controlled on Statin Therapy | PHASE3 | COMPLETED | 305 | — | — | Dec 8, 2020 | Jun 15, 2022 | Sep 22, 2025 | 40 | China |
The percent change from baseline in measured LDL-C at Week 8 will be analyzed in the modified intent-to-treat (mITT) population using a mixed effect model with repeated measures (MMRM) approach.
| Arm | Type | Description |
|---|---|---|
| Single pill combination (SPC) | EXPERIMENTAL | Once daily rosuvastatin 10 mg for 4 weeks, then once daily SPC ezetimibe 10 mg /rosuvastatin 10 mg (E10/R10) for 8 weeks |
| Rosuvastatin | ACTIVE_COMPARATOR | Once daily rosuvastatin 10 mg for 4 weeks, then once daily rosuvastatin 10 mg (R10) for 8 weeks |
| Name | Type | Description |
|---|---|---|
| Rosuvastatin | DRUG | Pharmaceutical form:Tablet Route of administration: Oral |
| SPC ezetimibe/rosuvastatin | DRUG | Pharmaceutical form:Tablet Route of administration: Oral |
| Rosuvastatin active capsule | DRUG | Pharmaceutical form:Capsule Route of administration: Oral |
| Placebo | DRUG | Pharmaceutical form:Tablet Route of administration: Oral |
Inclusion criteria : * Participant must be at least 18 years of age inclusive, at the time of signing the informed consent. * Patients with primary hypercholesterolemia. * Inclusion criteria in the run-in period: Participants who are not adequately controlled (defined by screening LDL-C \>2.6 mmol/...