Efficacy and Safety Study of Pitavastatin Compared to atoRvastatin in Type 2 dIabeTes Mellitus With Hypercholesterolemia
ESPRIT
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
1 other identifier
interventional
161
0 countries
N/A
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Apr 2008
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 27, 2009
CompletedFirst Posted
Study publicly available on registry
April 28, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedResults Posted
Study results publicly available
September 17, 2019
CompletedSeptember 17, 2019
July 1, 2019
1.1 years
April 27, 2009
July 10, 2019
August 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Patients Achieving LDL- C<100mg/dL
compare the proportion of patients achieving LDL- C\<100mg/dL
After 16wk drug administration
Secondary Outcomes (1)
The Change of LDL-C
After 16wk drug administration
Study Arms (2)
Pitavastatin Group
EXPERIMENTALAtorvastatin Group
ACTIVE COMPARATORInterventions
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 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
Eligibility Criteria
You may qualify if:
- Age: 25yrs\~75yrs
- Fasting TG \<400mg/dL, LDL-C ≥130mg/dL
- months \> Diagnosed Type2 DM, With OAD, HbA1c ≤ 10.0% or First Diagnosed Type2 DM, 6.5%≤HbA1c≤10.0%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Hoyoung Sohn
- Organization
- CMC
Study Officials
- PRINCIPAL INVESTIGATOR
Ho Young Shon, MD
Endocrinology, Kangnam Saint Mary's Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2009
First Posted
April 28, 2009
Study Start
April 1, 2008
Primary Completion
May 1, 2009
Study Completion
January 1, 2010
Last Updated
September 17, 2019
Results First Posted
September 17, 2019
Record last verified: 2019-07