Back to resultsEfficacy and Safety of Pactimibe in Patients With Atherosclerosis
Primary Purpose
Atherosclerosis
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Pactimibe
Sponsored by
About this trial
This is an interventional treatment trial for Atherosclerosis
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Efficacy of pactimibe versus placebo on the progression of atherosclerosis
Secondary Outcome Measures
Safety and tolerability of pactimibe versus placebo in patients with atherosclerosis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00185146
Brief Title
Efficacy and Safety of Pactimibe in Patients With Atherosclerosis
Official Title
Effect of Pactimibe on the Progression of Atherosclerosis as Measured by 2-D and 3-D Carotid Ultrasound
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sankyo Pharma Gmbh
4. Oversight
5. Study Description
Brief Summary
The effect of pactimibe on the reduction of atherosclerosis in the carotid artery will be assessed using carotid ultrasound
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Pactimibe
Primary Outcome Measure Information:
Title
Efficacy of pactimibe versus placebo on the progression of atherosclerosis
Secondary Outcome Measure Information:
Title
Safety and tolerability of pactimibe versus placebo in patients with atherosclerosis
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
P U Witte, MD, PhD, FFPM
Organizational Affiliation
IMFORM GmbH
Official's Role
Principal Investigator
Facility Information:
City
Munich
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Pactimibe in Patients With Atherosclerosis
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