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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

NCT04669041 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 305

Last updated 2025-09-22

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-08
Primary Completion
2022-06-15
Completion
2022-06-15

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04669041 on ClinicalTrials.gov