- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00889226
Efficacy and Safety Study of Pitavastatin Compared to atoRvastatin in Type 2 dIabeTes Mellitus With Hypercholesterolemia (ESPRIT)
August 26, 2019 updated by: JW Pharmaceutical
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
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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 .
Study Type
Interventional
Enrollment (Actual)
161
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pitavastatin Group
|
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:
|
Active Comparator: Atorvastatin Group
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of Patients Achieving LDL- C<100mg/dL
Time Frame: After 16wk drug administration
|
compare the proportion of patients achieving LDL- C<100mg/dL
|
After 16wk drug administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Change of LDL-C
Time Frame: After 16wk drug administration
|
The change of LDL-C between at 16-week and baseline
|
After 16wk drug administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ho Young Shon, MD, Endocrinology, Kangnam Saint Mary's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Actual)
May 1, 2009
Study Completion (Actual)
January 1, 2010
Study Registration Dates
First Submitted
April 27, 2009
First Submitted That Met QC Criteria
April 27, 2009
First Posted (Estimate)
April 28, 2009
Study Record Updates
Last Update Posted (Actual)
September 17, 2019
Last Update Submitted That Met QC Criteria
August 26, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Lipid Metabolism Disorders
- Hyperlipidemias
- Dyslipidemias
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypercholesterolemia
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Atorvastatin
- Pitavastatin
Other Study ID Numbers
- CWP_PTV4_704
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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