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

May 31, 2023 updated by: Daiichi Sankyo, Inc.
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

210

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2000

Study Completion

December 1, 2004

Study Registration Dates

First Submitted

September 27, 2006

First Submitted That Met QC Criteria

September 27, 2006

First Posted (Estimated)

September 28, 2006

Study Record Updates

Last Update Posted (Actual)

June 1, 2023

Last Update Submitted That Met QC Criteria

May 31, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 866-422 AIMS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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