Munich, Germany
NCT Number: NCT00185146
Efficacy and Safety of Pactimibe in Patients With Atherosclerosis
The effect of pactimibe on the reduction of atherosclerosis in the carotid artery will be assessed using carotid ultrasound
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Notify MeKey information
Conditions
Age range
30 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Pactimibe
DrugPrimary outcomes
-
Efficacy of pactimibe versus placebo on the progression of atherosclerosis
Secondary outcomes
-
Safety and tolerability of pactimibe versus placebo in patients with atherosclerosis
Sponsors and collaborators
Lead sponsor
Sankyo Pharma Gmbh
Industry
Registry information
Official study title
Effect of Pactimibe on the Progression of Atherosclerosis as Measured by 2-D and 3-D Carotid Ultrasound
Important dates
- Study start
- 2002
- Study completion
- 2005
- First posted
- Sep 16, 2005
- Registry last updated
- Mar 28, 2007
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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