Trials / Completed
CompletedNCT04669041
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
A Randomized Double-blinded, Double Dummy, Active-controlled, Parallel Design, Phase 3 Clinical Trial 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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 305 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Primary Objective: To demonstrate the superiority of the single pill combination (SPC) ezetimibe 10 mg/rosuvastatin 10 mg (E10/R10) compared to rosuvastatin 10 mg (R10), in the reduction of low density lipoprotein cholesterol (LDL-C) after 8 weeks. Secondary Objectives: * To evaluate the proportion of patients who attain their LDL-C goal. * To evaluate the effect of SPC (E10/R10) compared to rosuvastatin 10 mg (R10) in reduction of LDL-C at Week 4. * To evaluate the effect of SPC (E10/R10) compared to R10 on other lipid parameters at Week 4 and Week 8. * To evaluate the safety of SPC (E10/R10) and R10.
Detailed description
Study duration per participants is approximatively 16 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rosuvastatin | Pharmaceutical form:Tablet Route of administration: Oral |
| DRUG | SPC ezetimibe/rosuvastatin | Pharmaceutical form:Tablet Route of administration: Oral |
| DRUG | Rosuvastatin active capsule | Pharmaceutical form:Capsule Route of administration: Oral |
| DRUG | Placebo | Pharmaceutical form:Tablet Route of administration: Oral |
| DRUG | Placebo | Pharmaceutical form:Capsule Route of administration: Oral |
Timeline
- Start date
- 2020-12-08
- Primary completion
- 2022-06-15
- Completion
- 2022-06-15
- First posted
- 2020-12-16
- Last updated
- 2025-09-22
Locations
40 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04669041. Inclusion in this directory is not an endorsement.