Efficacy and Safety of Pactimibe in Patients With Atherosclerosis
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ClinicalTrials.gov Identifier: NCT00185146 |
Recruitment Status :
Completed
First Posted : September 16, 2005
Last Update Posted : March 28, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Atherosclerosis | Drug: Pactimibe | Phase 2 |
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 |

- Efficacy of pactimibe versus placebo on the progression of atherosclerosis
- Safety and tolerability of pactimibe versus placebo in patients with atherosclerosis

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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 |
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

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
Germany | |
Munich, Germany |
Principal Investigator: | P U Witte, MD, PhD, FFPM | IMFORM GmbH |
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 |
Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases |