Status:
COMPLETED
A Randomized, Double Blind Study To Compare The Effects Of Olmesartan Medoxomil Versus Placebo In Patients With Established Atherosclerosis
Lead Sponsor:
Daiichi Sankyo
Conditions:
Atherosclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2000
Trial Type :
INTERVENTIONAL
End Date :
December 1 2004
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT00382213
Start Date
June 1 2000
End Date
December 1 2004
Last Update
June 1 2023
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