EUCTR2010-022012-40-SE进行中（未招募）不适用
An Open-label, Randomised, Active-controlled, Parallel Group, Multicentre Phase 3 Study to Investigate the Long-term Safety, Tolerability and Efficacy of PA21 compared with Sevelamer Carbonate in Dialysis Patients with Hyperphosphataemia.Extension Study for Protocol PA-CL-05A.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 450
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
- •1. Subjects who have completed treatment in Protocol PA-CL-05A (Stage 1
- •or Stage 2) (except subjects randomised to the PA21 low dose group of the
- •Stage 2 primary efficacy assessment).
- •2. Subjects (or their legally acceptable representative) who have provided the
- •appropriate written informed consent. Subjects must provide written
- •informed consent before any study-specific procedures are performed
- •including screening procedures.
- •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 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •1. Subjects randomised to the PA21 low dose group of the Stage 2 primary
- •efficacy assessment of Protocol PA-CL-05A.
- •2. Subjects with hypercalcaemia (total serum calcium >2.75 mmol/L or
- •>11.00 mg/dL at the previous study visit in Protocol PA-CL-05A
- •(Week 20 for Stage 1, Week 26 for Stage 2)) (central laboratory values).
- •3. Subjects with hypocalcaemia (total serum calcium <1.9 mmol/L or
- •<7.6 mg/dL at the previous study visit in Protocol PA-CL-05A (Week 20
- •for Stage 1, Week 26 for Stage 2)) (central laboratory values).
- •4. Subjects with raised alanine aminotransferase or aspartate
- •aminotransferase >3 times the upper limit of the normal range at the
- •previous study visit in Protocol PA-CL-05A (Week 20 for Stage 1,
- •Week 24 for Stage 2) (central laboratory values).
- •5. Subjects taking any prohibited medications (see Section 7.7, Prohibited
- •Therapy and Concomitant Treatment, page 41).
- •6. Subjects who are pregnant (e.g., positive human chorionic gonadotropin
- •test at Week 20 Protocol PA-CL-05A), breast feeding or, if of childbearing
- •potential, not using adequate contraceptive precautions. Subjects must
- •agree to use adequate contraception during the study and for 1 month after
- •the last dose of the study medication.
- •Adequate methods of birth control are defined as those which result in a
- •low failure rate (i.e., less than 1% per year) when used consistently and
- •correctly such as implants, injectables, combined oral contraceptives, some
- •intra-uterine devices, sexual abstinence or vasectomised partner.
- •Non-childbearing potential includes being surgically sterilised at least
- •6 months prior to the study or post-menopausal, defined as amenorrhea for
- •at least 12 months.
- •7. Subjects with serum ferritin >2,000 mcg/L (>4.494 pmol/L) at the previous study visit in Protocol PA-CL-05A (Week 20 for Stage 1, Week
- •24 for Stage 2) (central laboratory values).
- •8. Subjects with any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.
研究者
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