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Completed

NCT Number: NCT00382213

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

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.

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

olmesartan medoxomil

Drug

Placebo

Drug

Primary outcomes

  1. The primary endpoint for the determination of efficacy will be a composite of

  2. ten circulating surrogate markers of atherosclerosis for vascular inflammation.

  3. The surrogate markers of vascular inflammation to be used will include

  4. C-reactive protein, MCP-1, M-CSF, VCAM-1, TNFα, IL-1, E-Selectin, ICAM-1, IL-6

  5. and MMP-9.

Secondary outcomes

  1. Individual circulating surrogate markers of atherosclerosis listed above

  2. (C-reactive protein, MCP-1, M-CSF, VCAM-1, TNFα, IL-1, E-Selectin, ICAM-1,

  3. IL-6 and MMP).

  4. Serum levels of TGF-β, PDGF, HGF, and PAI-1.

  5. The ratio of reduced to oxidized glutathione in the plasma as an indicator

  6. of oxidative stress (GSH/GSSG ratio).

  7. Composite of adhesion markers (VCAM-1, E-selectin, and ICAM-1).

  8. Composite of chemoattractant markers (MCP-1, M-CSF).

  9. Composite of Growth Factor Markers (PDGF, HGF, TGF-β).

  10. Assessment of atherosclerotic disease severity of the thoracic aorta as

  11. determined by transesophageal echocardiography (TEE) in patients enrolled

  12. on the basis of TEE-defined aortic atherosclerosis.

  13. Assessment of atherosclerotic disease severity of the peripheral arteries

  14. of the lower extremities as determined by the ankle brachial index (ABI).

  15. Endothelial function as determined by brachial artery diameter responses to

  16. hyperemic flow.

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Important dates

Study start
2000
Study completion
2004
First posted
Sep 28, 2006
Registry last updated
Jun 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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