EUCTR2006-002075-40-SE进行中（未招募）不适用
EVOLVE - Evaluation Of Cinacalcet HCl Therapy to Lower Cardiovascular Events - EVOLVE
Amgen Inc.0 个研究点目标入组 3,800 人开始时间: 2006年6月27日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3,800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Men or women = 18 years of age at screening.
- •Treated with maintenance hemodialysis 3 times a week for = 3 months before randomization.
- •PTH obtained from the central laboratory must be = 300 pg/mL (31.8 pmol/L).
- •Serum calcium obtained from the central laboratory must be = 8.4 mg/dL (2.1 mmol/L).
- •Ca x P obtained from the central laboratory must be = 45 mg2/dL2 (3.63 mmol2/L2).
- •In the investigator’s opinion, the subject is likely to be available during the follow up phase of the study.
- •Agree to be followed for study endpoints until the end of study.
- •Ethical - Before any study-specific procedure, the appropriate written informed consent must be obtained (see Section 13.1).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects will be ineligible for the study if they:
- •Have an unstable medical condition in the judgment of the investigator.
- •Parathyroidectomy in the 12 weeks before the date of informed consent.
- •Severe (ie, life-limiting) concomitant disease, including life-threatening malignancy or acquired immune deficiency syndrome (if likely to reduce life expectancy to less than 5 years), or any other life-threatening concomitant disease. Subjects with excised superficial lesions (eg, basal cell and squamous cell carcinoma of the skin) may be included.
- •Received therapy with cinacalcet within 3 months of randomization.
- •Hospitalization within 12 weeks of randomization for any of the following events:
- •a. Myocardial infarction
- •b. Unstable angina
- •c. Heart failure (including any unplanned presentation to a health care facility that would require mechanical intervention [ie, unplanned dialysis treatment])
- •d. Peripheral vascular disease (other than for dialysis vascular access revision)
- •History of seizure within 12 weeks prior to randomization.
- •Scheduled date for kidney transplant from a known living donor.
- •Anticipated parathyroidectomy within 6 months after randomization.
- •- Other investigational procedures are excluded.
- •- Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s).
- •- Subject has known sensitivity or intolerance to any of the products to be administered for the purpose of this study.
- •- Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.
- •- Subject is pregnant, is breast feeding, or is of child-bearing potential and not using adequate contraceptive precautions.
研究者
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