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

NCT00889226 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2019-09-17

Study results available
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Summary

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

Conditions

  • Hypercholesterolemia With Type2DM

Interventions

DRUG

Pitavastatin

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

DRUG

Atorvastatin

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

Sponsors & Collaborators

Principal Investigators

  • Ho Young Shon, MD · Endocrinology, Kangnam Saint Mary's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-05-31
Completion
2010-01-31

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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 NCT00889226 on ClinicalTrials.gov