PER-007-00已完成未知
AN ACTIVE-COMPARATOR- AND PLACEBO-CONTROLLED, PARALLEL-GROUP, DOUBLE-BLIND, 52-WEEKSTUDY TO ASSESS THE SAFETY AND EFFICACY OF MK-0966 IN RHEUMATOID ARTHRITIS PATIENTS
MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 0 人开始时间: 2000年2月3日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
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
- •a)The patient is ≥18 years old and does not present morbid obesity.
- •b)Patients must demonstrate a level of serum P-HCG that matches a non-pregnant status at the pre-study visit and must agree to abstain, use oral contraceptives or use the simple barrier contraception method (the couple will use condoms or patient diaphragms, contraceptive sponges or the IUD) beginning at least 7 days before treatment and for at least 14 days after Visit 12.0 or a discontinuation visit.
- •c)The patient must have satisfied at least four of the seven revised ARA criteria of 1987 for the diagnosis of rheumatoid arthritis.
- •d)The diagnosis of rheumatoid arthritis must be made at least 6 months before the study begins and not before 16 years of age.
- •e)Functional Class I, II or III of ARA.
- •f)The overall evaluation of the disease activity by the patient (VAS of 100 mm) in the pre-study visit is less than 80 mm.
- •g)There is a history of positive therapeutic benefit with NSAIDs.
- •h)Patients have regularly taken an NSAID and at a therapeutic dose level for at least 30 days before enrolling in the study.
排除标准
- •a)The patient is mentally or legally incapacitated, has significant emotional problems at the time of the study or has a history of psychosis.
- •b)The patient suffers from a simultaneous medical / arthropathic disease that could confuse or interfere with the evaluation of efficacy including, without limitation: systemic lupus, spondylarthropathy, polymyalgia rheumatica, gout, pseudogout, psoriatic arthritis, Paget´s disease and ochronosis.
- •c)The patient has a history of gastric, biliary, or small bowel surgery that causes poor malabsorption.
- •d)The estimated creatinine clearance of the patient [Men: (140-age) x weight (kg) / (serum creatinine (mg /dL) x 72); Women: (0.85) (140-age) weight (kg)/ serum creatinine (mg / dL) x 72] is <30 ml/min or serum creatinine is greater than 2.0.
- •e)The patient suffers from angina pectoris or congestive heart failure, with symptoms that occur during rest or minimal activity and / or has a history of myocardial infarction, coronary angioplasty or a coronary artery bypass was implanted during the last year.
- •f)The patient suffers from uncontrolled hypertension [Note: patients with hypertension who are under medical control may participate (diastolic blood pressure <95, systolic blood pressure <165)].
- •g)The patient has a history of stroke or transient ischemic attack in the last 2 years.
- •h)The patient has a history of hepatitis / liver disease that has been active in the past 2 years.
- •i)The patient has been previously exposed to MK-0966 in a clinical study (patients who have been previously enrolled in a study of MK-0966 and who have been assigned to placebo treatment may participate in this study).
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