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Simvastatin and Fenofibrate vs Simvastatin Alone in Patients With Type 2 Diabetes Mellitus and Acute Coronary Syndrome

NCT02015988 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-08-04

No results posted yet for this study

Summary

To test the hypothesis that early (within 5-21 days after index event) administration of combined lipid-lowering therapy in extremely high risk population of patients with type 2 diabetes mellitus (T2DM) and hypertriglyceridemia (HTG) who experienced acute coronary syndrome (ACS) will be effective and well tolerated in achievement of contemporary strict requirements for triglyceride (TG) levels as an independent risk factor in the case of HTG with diabetes.

Conditions

  • Acute Coronary Syndrome
  • Diabetes Mellitus, Type 2
  • Hypertriglyceridemia

Interventions

DRUG

Fenofibrate

DRUG

Simvastatin

Sponsors & Collaborators

  • Koval' O., MD

    lead OTHER

Principal Investigators

  • Olena A Koval', MD, PhD · State Institution "Dnipropetrovsk Medical Academy of Health Ministry of Ukraine"

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-09-30
Completion
2017-05-31

Countries

  • Ukraine

Study Locations

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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 NCT02015988 on ClinicalTrials.gov