Efficacy and Safety of Pactimibe in Patients With Atherosclerosis

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00185146
First received: September 12, 2005
Last updated: March 27, 2007
Last verified: March 2007

September 12, 2005
March 27, 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 ClinicalTrials.gov 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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Atherosclerosis
Drug: Pactimibe
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
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
Both
30 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00185146
SE-505/14
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