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Rosuvastatin/Ezetimibe vs Rosuvastatin in Korean Patients With Type 2 Diabetes Mellitus and Hypercholesterolemia

Y

Yuhan

Status and phase

Completed
Phase 4

Conditions

Hypercholesterolemia
Type 2 Diabetes Mellitus

Treatments

Drug: Monorova® Tab
Drug: Rosuvamibe® Tab

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

To assess the efficacy and safety of rosuvastatin/ezetimibe combination therapy compared to rosuvastatin monotherapy in Korean patients with type 2 diabetes mellitus and hypercholesterolemia

Full description

This study is to assess the efficacy and safety of Rosuvamibe® (rosuvastatin 5mg/ezetimibe 10mg) vs Monorova® (rosuvastatin 10mg) treated for 8 weeks in Korean patients with type 2 diabetes mellitus and hypercholesterolemia.

Enrollment

140 patients

Sex

All

Ages

19 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Aged 19 to 70 years
  2. Patient with type 2 diabetes who needs treatment for hypercholesterolemia
  3. Written informed consent

Exclusion criteria

  1. Administration of lipid lowering agents for more than one week within 4 weeks prior to screening visit

  2. Uncontrollable diabetes with HbA1c ≥ 8.5%

  3. Fasting LDL-C ≤ 70 mg/dL

  4. Fasting triglyceride ≥ 400 mg/dL

  5. Total cholesterol ≥ 300 mg/dL

  6. History of muscular disease or rhabdomyolysis due to use of statin

  7. Hypersensitive to rosuvastatin or ezetemibe

  8. Contraindications stated in the SPC of rosuvastatin or rosuvastatin/ezetimibe including the following:

    ① Severe renal disease (estimated GFR(MDRD) < 30mL/min/1.73m2)

    ② ALT, AST > 3x ULN or history of active liver disease

    ③ CPK > 3x ULN

  9. Administration of other investigational products within 30 days prior to screening visit

  10. Other than the above who is deemed to be ineligible to participate in the trial by investigator

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

140 participants in 2 patient groups

Rosuvamibe® Tab
Experimental group
Description:
Rosuvamibe® Tab (rosuvastatin 5mg/ezetimibe 10mg) qd for 8 weeks
Treatment:
Drug: Rosuvamibe® Tab
Monorova® Tab
Active Comparator group
Description:
Monorova® Tab (rosuvastatin 10mg) qd for 8 weeks
Treatment:
Drug: Monorova® Tab

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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