Safety and Efficacy Study of Pitavastatin in Patient With a Metabolic Syndrome

Metabolic Syndrome Clinical Trial

— ProPit  

Official title:

A Prospective Comparative Clinical Study to Identify Efficacy and Safety of Pitavastatin in Patients With a Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00640276
• Other study ID #: CWP_PTV_706
• Status: Completed
• Phase: Phase 4
• First received: March 18, 2008
• Last updated: March 28, 2012
• Start date: April 2008
• Est. completion date: June 2011

Study information

• Verified date: March 2012
• Source: JW Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

We will identify the influence of long-term treatment of Pitavastatin compared to non-treatment control group on the metabolic syndrome by evaluation of a change of metabolic syndrome component score. And we will additionally observe the changes of CVD risk factors like lipid profile, abdominal fat, insulin resistance and so on.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: June 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients aged between 18 and 75

• Patients with LDL = 100mg/dL

• Patients with metabolic syndrome

1. IFG: Fasting glucose = 100mg/dL

2. Abdominal Obesity: Waist circumference: men=90cm,women=85cm

3. 1 or more of the following

1. Triglyceride = 150mg/dL

2. HDL-C: men < 40mg/dL, women < 50mg/dL

3. Blood pressure: SBP = 130mmHg or DBP = 85mmHg or subject receiving anti-hypertensive treatment

Exclusion Criteria:

• uncontrolled hypertension (DBP = 95mmHg)

• taking diabetic drugs or with HbA1c > 8%

• LDL = 190mg/dL or Triglyceride = 400mg/dL

• coronary heart disease or other diseases caused by artherosclerosis

• malignancy within 6 months

• Serum creatinine = 2.0mg/dL

• ALT or AST = ULN*2.5

• CPK = ULN*2

• hypothyroidism

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia
• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Drug:
• pitavastatin
Pitavastatin 2mg daily once

Behavioral:
• Lifestyle Modification
conducting mainly exercises and diet

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Bundang-gu	Gyeonggi-do
Korea, Republic of	Hanyang Univ. Guri Hospital	Guri-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
JW Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A change of metabolic syndrome risk component		48week	Yes
Secondary	Changes of cardiometabolic profiles : lipid profiles, hs-CRP, adiponectin, HMW adiponectin		48week	No
Secondary	Changes of abdominal visceral fat		48week	No
Secondary	Changes of insulin resistance : OGTT(75g), HOMA		48week	Yes