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

Daiichi Sankyo

Status and phase: Completed; Phase 3

Conditions: Atherosclerosis

Treatments: Drug: Placebo; Drug: Olmesartan medoxomil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00382213

866-422 AIMS

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind