AtherosclerosisPhase 3NCT00382213
A Randomized, Double Blind Study To Compare The Effects Of Olmesartan Medoxomil Versus Placebo In Patients With Established Atherosclerosis
A Phase 3 study testing Olmesartan medoxomil in people with Atherosclerosis, run by Daiichi Sankyo.
Trial summary
The purpose of this study is to determine the efficacy of treatment with olmesartan medoxomil, an Angiotensin Receptor Blocker, compared to placebo on the blood levels of surrogate markers of vascular inflammation for atherosclerotic disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- Olmesartan medoxomil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- Jun 2000to Dec 2004
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or Females age less than or equal to 18
- TEE-defined Grade III or IV atherosclerotic disease of the thoracic aorta documented within the previous 90 days, or established atherosclerotic disease of the lower extremities as demonstrated by:
- a history of lower extremity peripheral vascular surgery for obstructive atherosclerotic disease, or
- a history of lower extremity peripheral arterial angioplasty for obstructive atherosclerotic disease, or
- a history of lower extremity amputation secondary to atherosclerotic disease, or
- an ABI <0.90 within the previous 90 days, or
- a history of claudication in patients with documented coronary artery disease (i.e., history of myocardial infarction, coronary revascularization, or coronary angiography demonstrating at least one obstructive coronary lesion with a 50% or greater stenosis).
Who cannot join
- Women of childbearing age who do not agree to utilize protocol approved contraceptive methods.
- Average pre-dose SBP < 100 or DBP < 60.
- Patients with any serious disorder including cardiovascular (ventricular arrhythmias, valvular disease or implantable defibrillator), renal, pulmonary, hepatic, gastrointestinal, endocrine/metabolic (excluding patients with controlled diabetes mellitus), hematologic/oncologic (including an active malignancy other than basal cell carcinoma or non-metastatic prostate cancer), neurologic, and psychiatric diseases.
- Patients with a history of MI, PTCA, CABG, heart failure, CVA or TIA within the last 30 days.
About this study
The purpose of this study is to determine the efficacy of treatment with olmesartan medoxomil, an Angiotensin Receptor Blocker, compared to placebo on the blood levels of surrogate markers of vascular inflammation for atherosclerotic disease. Patients will be randomized to receive either olmesartan medoxomil or placebo for one year.
- Conditions
- Atherosclerosis
- Being tested
- Olmesartan medoxomil, Placebo
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olmesartan medoxomilDrug
PlaceboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint for the determination of efficacy will be a composite of
ten circulating surrogate markers of atherosclerosis for vascular inflammation.
The surrogate markers of vascular inflammation to be used will include
C-reactive protein, MCP-1, M-CSF, VCAM-1, TNFα, IL-1, E-Selectin, ICAM-1, IL-6
and MMP-9.
Secondary outcomes (16)
Individual circulating surrogate markers of atherosclerosis listed above
(C-reactive protein, MCP-1, M-CSF, VCAM-1, TNFα, IL-1, E-Selectin, ICAM-1,
IL-6 and MMP).
Serum levels of TGF-β, PDGF, HGF, and PAI-1.
The ratio of reduced to oxidized glutathione in the plasma as an indicator
of oxidative stress (GSH/GSSG ratio).
Composite of adhesion markers (VCAM-1, E-selectin, and ICAM-1).
Composite of chemoattractant markers (MCP-1, M-CSF).
Composite of Growth Factor Markers (PDGF, HGF, TGF-β).
Assessment of atherosclerotic disease severity of the thoracic aorta as
determined by transesophageal echocardiography (TEE) in patients enrolled
on the basis of TEE-defined aortic atherosclerosis.
Assessment of atherosclerotic disease severity of the peripheral arteries
of the lower extremities as determined by the ankle brachial index (ABI).
Endothelial function as determined by brachial artery diameter responses to
hyperemic flow.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2006 (estimated)
- Study startJun 2000
- Study completionDec 2004
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.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 210 participants
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00382213
- Sponsor's protocol ID
- 866-422 AIMS
- Status last verified
- May 2023
- First submitted
- 27 Sep 2006
- Last updated
- 1 Jun 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind Study To Compare The Effects Of Olmesartan Medoxomil Versus Placebo In Patients With Established Atherosclerosis
- ClinicalTrials.gov ID
- NCT00382213
- Acronym / sponsor ID
- 866-422 AIMS
- Conditions
- Atherosclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- Jun 2000
- Study completion
- Dec 2004
- First posted
- 28 Sep 2006 (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 purpose of this study is to determine the efficacy of treatment with olmesartan medoxomil, an Angiotensin Receptor Blocker, compared to placebo on the blood levels of surrogate markers of vascular inflammation for atherosclerotic disease. Patients will be randomized to receive either olmesartan medoxomil or placebo for one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males or Females age less than or equal to 18
- TEE-defined Grade III or IV atherosclerotic disease of the thoracic aorta documented within the previous 90 days, or established atherosclerotic disease of the lower extremities as demonstrated by:
Key exclusion criteria (4 listed)
- Women of childbearing age who do not agree to utilize protocol approved contraceptive methods.
- Average pre-dose SBP < 100 or DBP < 60.
- Patients with any serious disorder including cardiovascular (ventricular arrhythmias, valvular disease or implantable defibrillator), renal, pulmonary, hepatic, gastrointestinal, endocrine/metabolic (excluding patients with controlled diabetes mellitus), hematologic/oncologic (including an active malignancy other than basal cell carcinoma or non-metastatic prostate cancer), neurologic, and psychiatric diseases.
- Patients with a history of MI, PTCA, CABG, heart failure, CVA or TIA within the last 30 days.
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 |
|---|---|---|
| Olmesartan medoxomil | Drug | – |
| Placebo | Drug | – |
Primary outcome
The primary endpoint for the determination of efficacy will be a composite of
ten circulating surrogate markers of atherosclerosis for vascular inflammation.
The surrogate markers of vascular inflammation to be used will include
C-reactive protein, MCP-1, M-CSF, VCAM-1, TNFα, IL-1, E-Selectin, ICAM-1, IL-6
and MMP-9.
16 secondary outcomes
Individual circulating surrogate markers of atherosclerosis listed above
(C-reactive protein, MCP-1, M-CSF, VCAM-1, TNFα, IL-1, E-Selectin, ICAM-1,
IL-6 and MMP).
Serum levels of TGF-β, PDGF, HGF, and PAI-1.
The ratio of reduced to oxidized glutathione in the plasma as an indicator
of oxidative stress (GSH/GSSG ratio).
Composite of adhesion markers (VCAM-1, E-selectin, and ICAM-1).
Composite of chemoattractant markers (MCP-1, M-CSF).
Composite of Growth Factor Markers (PDGF, HGF, TGF-β).
Assessment of atherosclerotic disease severity of the thoracic aorta as
determined by transesophageal echocardiography (TEE) in patients enrolled
on the basis of TEE-defined aortic atherosclerosis.
Assessment of atherosclerotic disease severity of the peripheral arteries
of the lower extremities as determined by the ankle brachial index (ABI).
Endothelial function as determined by brachial artery diameter responses to
hyperemic flow.
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 1 Jun 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Olmesartan medoxomil in people with Atherosclerosis, run by Daiichi Sankyo.
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 7 inclusion and 4 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 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The primary endpoint for the determination of efficacy will be a composite of. The study lists 5 primary outcomes in all. 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 1 Jun 2023.