Pitavastatin on Carotid Intima-Media Thickness - Full Text View

Sponsored by:	Kyoto Prefectural University of Medicine
Information provided by:	Kyoto Prefectural University of Medicine
ClinicalTrials.gov Identifier:	NCT00711919

Purpose

This study is aimed to analyze the effects of aggressive and conventional lipid lowering therapy with Pravastatin on carotid intima-media thickness (IMT) in patients with hyperlipidemia and abnormal thickening of IMT.

Condition	Intervention
Hyperlipidemia Carotid Artery Diseases	Drug: Pitavastatin

MedlinePlus related topics: Carotid Artery Disease

Drug Information available for: Pitavastatin NK 104

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Pitavastatin Evaluation of Atherosclerosis Regression by Intensive Cholesterol-Lowering Therapy

Further study details as provided by Kyoto Prefectural University of Medicine:

Primary Outcome Measures:

absolute changes in carotid intima-media thickness from baseline to final visit [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

relative change in carotid intima-media thickness [ Time Frame: 12 months ] [ Designated as safety issue: No ]
change in LDL-C, HDL-C, TG and RLP-C [ Time Frame: 12 months ] [ Designated as safety issue: No ]
change in hs-CRP and IL-6 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
new onset or recurrence of ischemic heart disease, heart failure, stroke and atherosclerosis obliterans [ Time Frame: 12 months ] [ Designated as safety issue: No ]
sudden death [ Time Frame: 12 months ] [ Designated as safety issue: No ]
side effects [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	July 2007
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Subjects are receiving Pitavastatin, starting at 2 mg, for 12 months. After administration, serum LDL-cholesterol should be kept between 100 and 80 mg/dL by controlling the dose of Pitavastatin or adding other anti-hyperlipidemia agents other than statins.	Drug: Pitavastatin comparison of different target levels of lipid lowering using Pitavastatin Subjects are receiving Pitavastatin, starting at 2 mg, for 12 months.
2: Active Comparator Subjects are receiving Pitavastatin, starting at 4 mg, for 12 months. After administration, serum LDL-cholesterol should be kept under 80 mg/dL by controlling the dose of Pitavastatin or adding other anti-hyperlipidemia agents other than statins.	Drug: Pitavastatin Subjects are receiving Pitavastatin, starting at 4 mg, for 12 months.

Eligibility

Ages Eligible for Study:	20 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosed as having hyperlipidemia
LDL-C at the time of enrollment is no less than 100
Common carotid IMT is 1.1 mm and over

Exclusion Criteria:

Received or planned to receive intervention on carotid arteries during the study period
Overt liver dysfunction (ALT; 100 IU/L and over)
Overt renal dysfunction (serum creatinine; 2.0 mg/dL and over)
Receiving Cyclosporin
Hyperreactive to Pitavastatin
During pregnancy or lactation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00711919

Locations

Japan
Kyoto Prefectural University of Medicine
Kyoto, Japan, 602-8566
Kyoto First Red Cross Hospital
Kyoto, Japan, 605-0981
Takeda Hospital
Kyoto, Japan, 600-8558
Japan, Kyoto
Saiseikai Kyoto Hospital
Nagaokakyo, Kyoto, Japan, 617-0814
Ayabe City Hospital
Ayabe, Kyoto, Japan, 623-0011
Tanabe Central Hospital
Kyotanabe, Kyoto, Japan, 610-0334
Nantan General Hospital
Nantan, Kyoto, Japan, 629-0197
Meiji University of Integrative Medicine Hospital
Nantan, Kyoto, Japan, 629-0392
Uji Hospital
Uji, Kyoto, Japan, 611-0011
Fukuchiyama City Hospital
Fukuchiyama, Kyoto, Japan, 620‐8505
Maizuru Medical Center
Maizuru, Kyoto, Japan, 625-8502
Kyoto Prefectural Yosanoumi Hospital
Yosano, Kyoto, Japan, 629-2261
Kumihama Hospital
Kyotango, Kyoto, Japan, 629-3400
Gakken Toshi Hospital
Seika, Kyoto, Japan, 619-0238
Maizuru Kyosai Hospital
Maizuru, Kyoto, Japan, 625-8585
Japan, Shiga
Shiga Hospital
Higashioumi, Shiga, Japan, 527-8505
Saiseikai Shigaken Hospital
Rittou, Shiga, Japan, 520-3046
Omihachiman Community Medical Center
Omihachiman, Shiga, Japan, 523-0082

Sponsors and Collaborators

Kyoto Prefectural University of Medicine

Investigators

Study Chair:

Hiroaki Matsubara, MD, PhD

Kyoto Prefectural University of Medicine

More Information

Responsible Party:	Kyoto Prefectural University of Medicine ( Hiroaki Matsubara )
Study ID Numbers:	C-255, UMIN000001229
Study First Received:	July 7, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00711919
Health Authority:	Japan: Institutional Review Board

Study placed in the following topic categories:

Atherosclerosis
Metabolic Diseases
Hyperlipidemias
NK 104
Vascular Diseases
Central Nervous System Diseases

Metabolic disorder
Brain Diseases
Carotid Artery Diseases
Cerebrovascular Disorders
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Enzyme Inhibitors
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 11, 2009