Efficacy and Safety of Pactimibe in Patients With Atherosclerosis

Effect of Pactimibe on the Progression of Atherosclerosis as Measured by 2-D and 3-D Carotid Ultrasound

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00185146

Enrollment

200

Registered

2005-09-16

Start date

2002-09-30

Completion date

2005-08-31

Last updated

2007-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis

Brief summary

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

Interventions

DRUGPactimibe

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

30 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Efficacy of pactimibe versus placebo on the progression of atherosclerosis	—

Secondary

Measure	Time frame
Safety and tolerability of pactimibe versus placebo in patients with atherosclerosis	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026