CClinicalTrials.gg
CompletedNCT00185146Updated Mar 28, 2007

Efficacy and Safety of Pactimibe in Patients With Atherosclerosis

A Phase 2 interventional study of Pactimibe in Atherosclerosis, sponsored by Sankyo Pharma Gmbh. Completed at 1 site in Germany. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2007-03-28.

Sponsored by Sankyo Pharma Gmbh · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
30 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Atherosclerosis

Browse trials for

03

In context

Atherosclerosis

1,567 studies on the registry are indexed under Atherosclerosis; 264 are open to participants now.

This study's enrollment of 200 is above the median of 106 across 882 interventional studies indexed under Atherosclerosis.

Browse Atherosclerosis studies →

Lead sponsor

Sankyo Pharma Gmbh is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
200 participants

Interventions

  • DrugPactimibe
06

What researchers measure

Primary outcomes

  1. Efficacy of pactimibe versus placebo on the progression of atherosclerosis

Secondary outcomes

  1. Safety and tolerability of pactimibe versus placebo in patients with atherosclerosis

07

Study locations

1 site
  • Munich, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00185146
Lead sponsor
Sankyo Pharma Gmbh
First posted
Sep 16, 2005
Start date
Sep 2002
Completion
Aug 2005
Last update
Mar 28, 2007

Study contacts

P U Witte, MD, PhD, FFPM
principal investigator · IMFORM GmbH
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2007. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion