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

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00382213
First received: September 27, 2006
Last updated: NA
Last verified: September 2006
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Atherosclerosis
Drug: Olmesartan medoxomil
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind Study To Compare The Effects Of Olmesartan Medoxomil Versus Placebo In Patients With Established Atherosclerosis

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 210
Study Start Date: June 2000
Estimated Study Completion Date: December 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00382213     History of Changes
Other Study ID Numbers: 866-422 AIMS
Study First Received: September 27, 2006
Last Updated: September 27, 2006
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Olmesartan
Olmesartan medoxomil
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014