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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

September 27, 2006
September 27, 2006
June 2000
Not Provided
  • 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.
Same as current
No Changes Posted
  • 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.
Same as current
Not Provided
Not Provided
 
A Randomized, Double Blind Study To Compare The Effects Of Olmesartan Medoxomil Versus Placebo In Patients With Established Atherosclerosis
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Atherosclerosis
  • Drug: Olmesartan medoxomil
  • Drug: Placebo
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
210
December 2004
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00382213
866-422 AIMS
Not Provided
Not Provided
Daiichi Sankyo Inc.
Not Provided
Not Provided
Daiichi Sankyo Inc.
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP