Efficacy and Safety of Pactimibe in Patients With Atherosclerosis

Daiichi Sankyo

Status and phase: Completed; Phase 2

Conditions: Atherosclerosis

Treatments: Drug: Pactimibe

Study type: Interventional

Funder types: Industry

Identifiers

NCT00185146

SE-505/14

Details and patient eligibility

About

The effect of pactimibe on the reduction of atherosclerosis in the carotid artery will be assessed using carotid ultrasound

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Increased cardiovascular risk (i.e. history of myocardial infarction, stroke, diabetes mellitus, left ventricular hypertrophy)
• Intima-media thickness greater than or equal to 0.8 mm as measured by ultrasonography
• Negative pregnancy test for females

Exclusion criteria

• Whole blood donation (greater than or equal to 450 ml) during the last three months before study start
• Unstable angina, congestive heart failure or uncontrolled hypertension
• Renal disease including nephrectomy and/or renal transplant
• Hepatic disease or abnormal liver function parameters
• Drug abuse or alcohol addiction

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind