Overview

This trial is active, not recruiting.

Conditions hyperlipidemia, carotid artery diseases
Treatments pitavastatin
Sponsor Kyoto Prefectural University of Medicine
Start date July 2007
End date December 2009
Trial size 300 participants
Trial identifier NCT00711919, C-255, UMIN000001229

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(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.
pitavastatin
comparison of different target levels of lipid lowering using Pitavastatin Subjects are receiving Pitavastatin, starting at 2 mg, for 12 months.
(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.
pitavastatin
Subjects are receiving Pitavastatin, starting at 4 mg, for 12 months.

Primary Outcomes

Measure
absolute changes in carotid intima-media thickness from baseline to final visit
time frame: 12 months

Secondary Outcomes

Measure
relative change in carotid intima-media thickness
time frame: 12 months
change in LDL-C, HDL-C, TG and RLP-C
time frame: 12 months
change in hs-CRP and IL-6
time frame: 12 months
new onset or recurrence of ischemic heart disease, heart failure, stroke and atherosclerosis obliterans
time frame: 12 months
sudden death
time frame: 12 months
side effects
time frame: 12 months

Eligibility Criteria

Male or female participants from 20 years up to 80 years old.

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

Additional Information

Official title Pitavastatin Evaluation of Atherosclerosis Regression by Intensive Cholesterol-Lowering Therapy
Trial information was received from ClinicalTrials.gov and was last updated in September 2009.
Information provided to ClinicalTrials.gov by Kyoto Prefectural University of Medicine.