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

• Sponsor: JW Pharmaceutical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00640276
• Collaborator: (none)
• Enrollment: 187
• Locations: 2
• Arms: 2
• Duration (Months): 38
• Patients Per Site: 93.5
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolemia; Metabolic Syndrome	Drug: pitavastatin; Behavioral: Lifestyle Modification	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 187 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective Comparative Clinical Study to Identify Efficacy and Safety of Pitavastatin in Patients With a Metabolic Syndrome
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Feb 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: T Lifestyle modification + active drug(Pitavastatin)	Drug: pitavastatin; Pitavastatin 2mg daily once; Other Names: Livaro
Other: C Lifestyle Modification	Behavioral: Lifestyle Modification; conducting mainly exercises and diet

Outcome Measures

Primary Outcome Measures

1. A change of metabolic syndrome risk component [48week]

Secondary Outcome Measures

1. Changes of cardiometabolic profiles : lipid profiles, hs-CRP, adiponectin, HMW adiponectin [48week]

2. Changes of abdominal visceral fat [48week]

3. Changes of insulin resistance : OGTT(75g), HOMA [48week]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

4. Triglyceride ≥ 150mg/dL

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

6. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Bundang-gu	Gyeonggi-do	Korea, Republic of	463-707
2	Hanyang Univ. Guri Hospital	Guri-si	Gyeonggi-do	Korea, Republic of	471-701

Sponsors and Collaborators

• JW Pharmaceutical

Investigators

• Study Chair: Chang Beom Lee, Hanyang Univ. Guri Hospital
• Study Chair: Hak Chul Jang, Seoul National University Bundang Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: JW Pharmaceutical
• ClinicalTrials.gov Identifier: NCT00640276
• Other Study ID Numbers: CWP_PTV_706
• First Posted: Mar 21, 2008
• Last Update Posted: Mar 30, 2012
• Last Verified: Mar 1, 2012

• Keywords provided by JW Pharmaceutical: pitavastatin; metabolic syndrome; metabolic syndrome risk score; hypercholesterolemia
• Additional relevant MeSH terms: Metabolic Syndrome; Hypercholesterolemia; Syndrome; Pitavastatin

Study Results

No Results Posted as of Mar 30, 2012