AtherosclerosisPhase 2NCT00185146
Efficacy and Safety of Pactimibe in Patients With Atherosclerosis
A Phase 2 study testing Pactimibe in people with Atherosclerosis, run by Sankyo Pharma Gmbh at 1 site in Germany.
Trial summary
The effect of pactimibe on the reduction of atherosclerosis in the carotid artery will be assessed using carotid ultrasound Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- Pactimibe
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2002to Aug 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Atherosclerosis
- Being tested
- Pactimibe
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PactimibeDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of pactimibe versus placebo on the progression of atherosclerosis
Secondary outcomes (1)
Safety and tolerability of pactimibe versus placebo in patients with atherosclerosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startSep 2002
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Sankyo Pharma Gmbh
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- P U Witte, MD, PhD, FFPM, Principal investigator, IMFORM GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00185146
- Sponsor's protocol ID
- SE-505/14
- Status last verified
- Mar 2007
- First submitted
- 12 Sep 2005
- Last updated
- 28 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pactimibe on the Progression of Atherosclerosis as Measured by 2-D and 3-D Carotid Ultrasound
- ClinicalTrials.gov ID
- NCT00185146
- Acronym / sponsor ID
- SE-505/14
- Conditions
- Atherosclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Sankyo Pharma GmbhIndustry (pharma, biotech, devices)
- Study start
- Sep 2002
- Study completion
- Aug 2005
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effect of pactimibe on the reduction of atherosclerosis in the carotid artery will be assessed using carotid ultrasound
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pactimibe | Drug | – |
Primary outcome
Efficacy of pactimibe versus placebo on the progression of atherosclerosis
1 secondary outcome
Safety and tolerability of pactimibe versus placebo in patients with atherosclerosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
P U Witte, MD, PhD, FFPM principal investigator
IMFORM GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pactimibe in people with Atherosclerosis, run by Sankyo Pharma Gmbh at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of pactimibe versus placebo on the progression of atherosclerosis. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2007.