PER-075-07已完成未知
A Randomized, Double Blind, Parallel-group Study Of Cardiovascular Safety In Osteoarthritis Or Rheumatoid Arthritis Patients With Or At High Risk For Cardiovascular Disease Comparing Celecoxib With Naproxen And Ibuprofen
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- PFIZER S.A.,
- 入组人数
- 325
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 0（—）
入选标准
- •Men and women, 18 years of age or older at the time of consent,
- •If you are a woman and are of childbearing age or have been postmenopausal for less than two years, you must have been using adequate contraception since your last menstrual period and will use appropriate contraception during the study. You should not be breast-feeding and the pregnancy test in a sample taken in the last 24 hours before receiving the first dose of study medication should be negative. For the purposes of this study, postmenopausal women for less than 2 years are considered to retain their fertility potential and contraceptive methods that are considered medically acceptable are hormonal contraceptives, an intrauterine device or a barrier method with spermicide,
- •Clinical diagnosis of OA or RA, with a minimum duration of 6 months (refer to Annex 6 where the criteria of the American College of Rheumatology (ACR) appear only as a guide),
- •All subjects must have needed a chronic analgesic regimen for at least 6 months. Subjects with RA who are receiving a disease-modifying antirheumatic drug (DMARD) or oral corticosteroid therapy (less than or equal to 20 mg of prednisone or its equivalent) should have been receiving the same medications for 3 months and must be under a stable dosing scheme for one month (which means that they have not changed the dose or the frequency of its administration),
- •The investigator considers that the subject requires and is eligible for a chronic daily therapy with an NSAID to control the signs and symptoms of arthritis;
- •The subject has an established CVD or a high risk of CVD, which is defined as one of the following criteria (a-d): a. Coronary disease b. Occlusive disease of arteries other than coronary arteries c. Diabetes mellitus: clinical diagnosis of type I or type II diabetes d. High risk of atherosclerotic vascular disease e. History of dyslipidemia (defined as LDL> 150 mg / dL [3.885 mmol / L] or high density lipoprotein (HDL) <40 mg / dL [1.036 mmol / L] in women and <35 mg / dL [ 0.906 mmol / L] in men). Subjects who are currently receiving lipid-lowering therapy with a statin-type medication automatically meet this criterion.
- •The researcher believes that the subject is willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other trial procedures throughout the study period,
- •Evidence of an informed consent document, signed and dated in person, indicating that the subject (or his or her legally acceptable representative) received all pertinent information about the trial.
排除标准
- •The subject has had acute joint trauma with active symptoms that may interfere with the evaluation of arthritis,
- •There is a plan for a surgical or other invasive procedure during the course of the study,
- •The subject has a known hypersensitivity to celecoxib, ibuprofen, naproxen, aspirin (acetylisalicylic acid) or esomeprazole or has had asthma, urticaria or allergic-type reactions after taking sulfonamides, proton pump inhibitors (PPI), lactose or NSAIDs ,
- •The subject has received some treatment with rheumatological disease modifiers or oral corticosteroids, which has not been stable (which is defined as receiving the same medication for 3 months with the same dosing schedule for 1 month before randomization; see Section 5.5.3),
- •The subject is receiving oral corticosteroid therapy with a daily dose of> 20 mg of prednisone or its equivalent,
- •The subject requires and is receiving treatment with more than 325 mg of aspirin per day,
- •The subject is currently receiving or there is a significant likelihood that they will require treatment during the study period with medications that are not allowed by the study protocol (see sections 5.5.1 and 5.5.2), including warfarin or another coumarin or lithium anticoagulant,
- •The subject had an MI or a documented stroke in the last 3 months before the randomization,
- •The subject underwent CABG surgery or any major surgery (cardiac or non-cardiac) in the last 3 months before randomization,
- •At the time of study screening, the subject has plans for coronary revascularization (PCI or CABG); in the case of a planned coronary revascularization, the subject can return to the screening once 3 months after the revascularization has elapsed,
- •The subject has an unstable condition, which is defined as any of the following: a. Unstable angina (definition of AHA / ACC) in the three months before randomization b. Uncontrolled hypertension (defined as a systolic RA greater than 140 mm Hg and / or a diastolic RA greater than 90 mm Hg at baseline, see section 7.3.2 Physical examination and vital signs)
- •The patient has evidence of cardiac electrophysiological instability, which includes uncontrolled complex ventricular arrhythmia, uncontrolled atrial fibrillation or flutter, or uncontrolled supraventricular tachycardias in the three months before randomization. The presence of an implantable defibrillator is not a contraindication to recruitment,
- •The subject has a Class III or IV heart failure (NYHA) or left ventricular dysfunction with an ejection fraction of 35%;
- •The subject has a diagnosis or has received treatment for an esophageal, gastric, pyloric or duodenal canal ulcer in the last 60 days before the randomization,
- •The subject has a history of perforation, obstruction, or bleeding G1 in the last 6 months before randomization,
- •Subject has inflammatory bowel disease (eg, Crohn´s disease or ulcerative colitis) or other known and active type Gl, hepatic, renal or coagulation disorder,
- •The subject has values of aspartate aminotransferase (AST [SGOT]), alanine aminotransferase (ALT [SGRT]) or nitrogen urelco (UN) 2.0 times greater than the upper limit of the normal range; a creatinine greater than 1.7 mg / dL (150 pmol / L) in men or 1.5 mg / dL (130 pmol / L) in women,
- •The subject has an active malignancy of any kind. Subjects who have a history of basal cell carcinoma or squamous cell carcinoma of t
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