A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTRIC STUDY TO EVALUATE THE EFFECTS OF ROFECOXIB IN REDUCING THE RISK OF PROSTATE CANCER (VIP STUDY).

ELI LILLY INTERAMERICA INC.,0 个研究点目标入组 0 人开始时间: 2003年8月28日最近更新: 2023年9月4日

试验速览

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•a. The patient is a male person> 50 years old and <75 years old, with a life expectancy> 6 years
•b. The patient has a PSA in the selection (Visit 1)> 2.5 ng / mL and <4 ng / mL OR PSA> 4 ng / mL and <10 ng / mL and a normal biopsy (no evidence of malignancy or prosthetic intraepithelial neoplasia) High grade - minor grades are accepted - within the 1st year of selection (Visit 1). Reports and pathology sheets should be sent for central reading and evaluation.
•c. The patient underwent a digital rectal examination within 4 weeks of the selection (Visit 1) that did NOT indicate signs of malignancy.

•a. The patient has active, uncontrolled hypertension (diastolic blood pressure when sitting> 95 mm Hg or systolic blood pressure when sitting> 165 mm Hg). Patients with medically controlled hypertension can participate.
•b. The patient has congestive heart failure with symptoms that are present at rest or with minimal activity.
•c. The patient has unstable angina - angina that occurs at rest or with minimum activity.
•d. The patient has had a history of stroke or attack
•transient ischemic disease (TIA), myocardial infarction, coronary angioplasty percutaneous transluminal, or coronary artery graft within 6 months of the selection (Visit 1).
•e. The patient suffers, regardless of the etiology, malabsorption gastrointestinal clinic.

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