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Status:

COMPLETED

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

Lead Sponsor:

Sanofi

Conditions:

Hypercholesterolemia

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief 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 densi...

Detailed Description

Study duration per participants is approximatively 16 weeks.

Eligibility Criteria

Inclusion

  • 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/L (100 mg/dL) and ≤4.9 mmol/L (190 mg/dL)with a 10 mg stable daily dose of rosuvastatin, or equipotent statin for 4 weeks prior to the screening visit, without any other lipid modifying therapy (LMT). Inclusion criteria in the randomized double-blind period: Participants who are not adequately controlled based on sample taken at qualifying pre randomization visit, despite stabilized dose of rosuvastatin 10 mg (defined by measured LDL-C ≥2.6 mmol/L (100 mg/dL) and ≤4.9 mmol/L (190 mg/dL).
  • Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Capable of giving signed informed consent.
  • Exclusion criteria:
  • Homozygous familial hypercholesterolemia (FH) (clinically or previous genotyping).
  • Patient who has received LDL-C plasmapheresis treatment within 2 months prior to the screening visit, or has plans to receive it during the study.
  • Recently diagnosed (within 3 months prior to the screening visit) myocardial infarction (MI), unstable angina, myocardial revascularization (percutaneous coronary intervention \[PCI\], coronary artery bypass graft surgery \[CABG\]), transient ischemic attack (TIA), or stroke, carotid revascularization, endovascular procedure or surgical intervention for peripheral vascular disease.
  • Planned to undergo scheduled PCI, CABG, carotid or peripheral revascularization during the study.
  • Severe hypertension (treated or untreated) with systolic blood pressure (SBP) \>160 mm Hg or diastolic blood pressure (DBP) \>100 mm Hg at study entry.
  • History of severe congestive heart failure (New York Heart Association Class IIIb or IV) within the past 12 months.
  • Presence of any clinically significant uncontrolled endocrine disease known to influence serum lipids or lipoproteins, according to Investigator's medical judgement.
  • Uncontrolled (as determined by fasting glucose \>180 mg/mL or HbA1c \>9%) or newly diagnosed (within 3 months of study entry) diabetes mellitus at the screening visit.
  • History of cancer within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer.
  • Conditions/situations such as:
  • Patient with a short life expectancy.
  • Patient with conditions/concomitant diseases making them non-evaluable for the primary efficacy endpoint, according to Investigator's medical judgement.
  • Requirement for concomitant treatment that could bias primary evaluation, according to Investigator's medical judgement.
  • Impossibility to meet specific protocol requirements (eg, ability to make study visits).
  • Patient is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other study staff or relative thereof directly involved in the conduct of the study.
  • Patient not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or patients potentially at risk of noncompliance to study procedures.
  • Known history of hypersensitivity reaction to statins and/or ezetimibe.
  • Current myopathy.
  • A history of statin-induced myopathy or rhabdomyolysis.
  • Current active liver disease including unexplained, persistent elevations of serum transaminases and any serum transaminase elevation exceeding 3 x upper limit of normal (ULN) range at the screening visit.
  • All contraindications to the active comparator (rosuvastatin) and background therapies or warning/precaution of use (when appropriate) as displayed in the respective National Product Labeling.
  • Patients not previously instructed on a cholesterol-lowering diet prior to the screening visit.
  • Use of systemic corticosteroids, unless used as replacement therapy for pituitary/adrenal disease with a stable regimen for at least 6 weeks prior to screening visit.
  • Use of hormone replacement therapy or oral contraceptives unless regimen has been stable in the past 6 weeks prior to the screening visit and no plans to change the regimen during the study.
  • Concomitant administration of cyclosporine (at screening and randomization visits).
  • Human immunodeficiency virus (HIV) patients receiving protease inhibitors (at screening and randomization visits).
  • Patient who has taken any active investigational drugs (E10/R10) within 1 month or 5 half-lives prior to screening, whichever is longer.
  • Laboratory findings obtained during the screening visit (V1):
  • Fasting serum TGs \>400 mg/dL.
  • Positive serum pregnancy test.
  • Serum creatine kinase \>3 times ULN.
  • Thyroid-stimulating hormone (TSH) \< lower limit of normal (LLN) or \> ULN.
  • Glycated hemoglobin A1c (HbA1c) \>9%.
  • Estimated glomerular filtration rate \<30 mL/min/1.73 m2.
  • Alanine aminotransferase or AST \>3 x ULN.
  • Individuals accommodated in an institution because of regulatory or legal order; prisoners or subjects who are legally institutionalized.
  • Any technical/administrative reason (eg, patient homeless) that makes it impossible to enroll/randomize the patient in the study.
  • Alcohol abuse according to Investigator's medical judgement.
  • Participants are dependent on the Sponsor or Investigator (in conjunction with Section 1.61 of the ICH-GCP Ordinance E6).
  • Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals.
  • Any specific situation during study implementation/course that may rise ethics considerations.
  • Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Exclusion

    Key Trial Info

    Start Date :

    December 8 2020

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    June 15 2022

    Estimated Enrollment :

    305 Patients enrolled

    Trial Details

    Trial ID

    NCT04669041

    Start Date

    December 8 2020

    End Date

    June 15 2022

    Last Update

    September 22 2025

    Active Locations (40)

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    Page 1 of 10 (40 locations)

    1

    Investigational Site Number :1560033

    Baotou, China, 014010

    2

    Investigational Site Number :1560001

    Beijing, China, 100029

    3

    Investigational Site Number :1560068

    Beijing, China, 100050

    4

    Investigational Site Number :1560021

    Beijing, China, 101200