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. Identifier: NCT00185146
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : March 28, 2007
Information provided by:
Daiichi Sankyo, Inc.

September 12, 2005
September 16, 2005
March 28, 2007
September 2002
Not Provided
Efficacy of pactimibe versus placebo on the progression of atherosclerosis
Same as current
Complete list of historical versions of study NCT00185146 on Archive Site
Safety and tolerability of pactimibe versus placebo in patients with atherosclerosis
Same as current
Not Provided
Not Provided
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
The effect of pactimibe on the reduction of atherosclerosis in the carotid artery will be assessed using carotid ultrasound
Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Drug: Pactimibe
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
August 2005
Not Provided

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
Sexes Eligible for Study: All
30 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
Not Provided
Sankyo Pharma Gmbh
Not Provided
Principal Investigator: P U Witte, MD, PhD, FFPM IMFORM GmbH
Daiichi Sankyo, Inc.
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP