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To Assess With Ezefeno Tab. in Patients With Dyslipidemia and T2DM

Study acronym: ENSEMBLE
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Phase: Not specified to Not applicable
    • Trial status: Not Yet Recruiting to Recruiting
    • Interventions: Statin and Ezefeno (Drug), Statin doubling (Drug) to Dose escalation of moderate-intensity statin (Drug), Ezetimibe/fenofibrate (Ezefeno) and moderate-intensity statin (Drug)
    • Site details revised
    v3
  2. Re-verified, no change to tracked fieldsv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this Randomized controlled trials is to assess in the long term efficacy and safety of ezefeno. The primary endpoint are: * major adverse cardiovascular events within 48 months of the trial duration * microvascular events within 48 months of the trial duration
Trial Details
NCT Number NCT06293417
Lead Sponsor Korea University Anam Hospital
Conditions
(from sponsor)		 T2DM (Type 2 Diabetes Mellitus), Dyslipidemias
Related terms Diabetes Mellitus, Type 2, Dyslipidemias
Enrollment 3,958 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov