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Efficacy and Safety of Pactimibe in Patients With Atherosclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00185146
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : March 28, 2007
Sponsor:
Information provided by:
Daiichi Sankyo, Inc.

Study Description
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Brief Summary:
The effect of pactimibe on the reduction of atherosclerosis in the carotid artery will be assessed using carotid ultrasound

Condition or disease Intervention/treatment Phase
Atherosclerosis Drug: Pactimibe Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effect of Pactimibe on the Progression of Atherosclerosis as Measured by 2-D and 3-D Carotid Ultrasound
Study Start Date : September 2002
Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Efficacy of pactimibe versus placebo on the progression of atherosclerosis

Secondary Outcome Measures :
  1. Safety and tolerability of pactimibe versus placebo in patients with atherosclerosis

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00185146


Locations
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Germany
Munich, Germany
Sponsors and Collaborators
Sankyo Pharma Gmbh
Investigators
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Principal Investigator: P U Witte, MD, PhD, FFPM IMFORM GmbH
More Information
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ClinicalTrials.gov Identifier: NCT00185146    
Other Study ID Numbers: SE-505/14
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: March 28, 2007
Last Verified: March 2007
Additional relevant MeSH terms:
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Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases