A Randomized, Double Blind Study To Compare The Effects Of Olmesartan Medoxomil Versus Placebo In Patients With Established Atherosclerosis

NCT00382213 | Completed Phase 3

• 1 other identifier: 866-422 AIMS
• Study Type: interventional
• Target: 210
• Locations: 0 countries
• Sites: N/A

Brief 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. Patients will be randomized to receive either olmesartan medoxomil or placebo for one year.

Conditions

Atherosclerosis

Outcome Measures

Primary Outcomes (5)

• 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

Interventions

Olmesartan medoxomil DRUG

Placebo DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daiichi Sankyo: lead

MeSH Terms

Conditions

Atherosclerosis

Interventions

Olmesartan Medoxomil

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 27, 2006
• First Posted: September 28, 2006
• Study Start: June 1, 2000
• Study Completion: December 1, 2004
• Last Updated: June 1, 2023

Record last verified: 2023-05