Skip to main content
OpenTrials
Completed

NCT Number: NCT00889226

Efficacy and Safety Study of Pitavastatin Compared to atoRvastatin in Type 2 dIabeTes Mellitus With Hypercholesterolemia

A randomized, open label, dose titration study to evaluate the efficacy and safety of Pitavastatin compared to atorvastatin in Type 2 Diabetes Mellitus with hypercholesterolemia

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypercholesterolemia With Type2DM

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

To evaluate the effect of pitavastatin compared to atorvastatin on the change of Lipid profiles, ApoA1, ApoB, adiponectin and baPWV as a marker of atherosclerosis in Type 2DM .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 25yrs~75yrs
  • Fasting TG <400mg/dL, LDL-C ≥130mg/dL
  • 3months > Diagnosed Type2 DM, With OAD, HbA1c ≤ 10.0% or First Diagnosed Type2 DM, 6.5%≤HbA1c≤10.0%

Exclusion criteria

  • Type1 DM, Gestational diabetes
  • Patient need to treat with Insulin
  • Patient with operational treatment for severe diabetic complication
  • Uncontrolled Hypothyroidism
  • Unstable angina, MI, transient ischemic attack(TIA), Stroke, PCI, Heart Failure within 3 months (NYHA class4)
  • Severe Hypertension (SBP ≥ 180 or DBP ≥ 110mmHg)
  • Renal disorder (Serum creatinine ≥ 2.0mg/dL)
  • Hepatic disorder (AST or ALT ≥ 2.5 X UNL)
  • Creatinine Kinase > 2.5 X UNL
  • Gravida or lactation phase
  • Administration of Atorvastatin, Rosuvastatin, Pitavastatin

Treatment and study plan

Pitavastatin

Drug

Drug: Pitavastatin 2mg daily for 8wks after initial visit. After assessment of LDL-C <100mg/dL at 8wks → Dose adjustment Yes → 2mg daily for second 8wks No → 4mg daily for second 8wks

Other names: Livalo

atorvastatin

Drug

Drug: Atorvastatin 10mg daily for 8wks after initial visit. After assessment of LDL-C <100mg/dL at 8wks → Dose adjustment Yes → 10mg daily for second 8wks No → 20mg daily for second 8wks

Other names: Lipitor

Primary outcomes

  1. Proportion of Patients Achieving LDL- C<100mg/dL

    Time frame: After 16wk drug administration

    compare the proportion of patients achieving LDL- C<100mg/dL

Secondary outcomes

  1. The Change of LDL-C

    Time frame: After 16wk drug administration

    The change of LDL-C between at 16-week and baseline

Sponsors and collaborators

Lead sponsor

JW Pharmaceutical

Industry

Registry information

Official study title

A Randomized, Open Label, Dose Titration Study to Evaluate the Efficacy and Safety of Pitavastatin Compared to atoRvastatin in Type 2 dIabeTes Mellitus With Hypercholesterolemia

Acronym: ESPRIT

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Apr 28, 2009
Registry last updated
Sep 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.