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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
History of Changes
  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:

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources

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
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 June 18, 2013