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
  Purpose

The effect of pactimibe on the reduction of atherosclerosis in the carotid artery will be assessed using carotid ultrasound


Condition Intervention Phase
Atherosclerosis
Drug: Pactimibe
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effect of Pactimibe on the Progression of Atherosclerosis as Measured by 2-D and 3-D Carotid Ultrasound

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

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

Estimated Enrollment: 200
Study Start Date: September 2002
Estimated Study Completion Date: August 2005
  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00185146

Locations
Germany
Munich, Germany
Sponsors and Collaborators
Sankyo Pharma Gmbh
Investigators
Principal Investigator: P U Witte, MD, PhD, FFPM IMFORM GmbH
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00185146     History of Changes
Other Study ID Numbers: SE-505/14
Study First Received: September 12, 2005
Last Updated: March 27, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 31, 2014