A Multi-Center, Open-Label Extension Study to Protocol AC-052-405 to Evaluate the Safety and Efficacy of Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 17
- 主要终点
- Change in 6-minute Walk Distance
研究概览
简要总结
This 6-month open label study will evaluate the long term safety of bosentan (via oxygen saturation) and efficacy (exercise capacity) in patients who have completed the BREATHE-5 study (PAH related to Eisenmenger physiology). Treatment duration is 6 months.
详细描述
This is a multicenter, open-label, single -arm study with bosentan, initial dose of 62.5 mg b.i.d., with a target dose of 125 mg b.i.d. All patients will be assessed for eligibility during the baseline visit (same as Week 16, end of study BREATHE-5 visit), and will have the option to enter into the open-label extension study at a starting dose of 62.5 mg b.i.d., for safety reasons. Visit 2 is required as a safety visit to assess oxygen saturation (SpO2) after 1 week of bosentan treatment. Patients will return for Visit 4 after 4 weeks of treatment, and the dose will be up-titrated to 125 mg b.i.d. or maintained at 62.5 mg b.i.d. at the judgement of the investigator. Data will be collected for a total of 24 weeks or until the sponsor decides to stop the study. If the results from Study AC-052-403 or AC-052-405 demonstrate significant safety issues, this extension study may be terminated at the sponsor's request.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients stable with PAH upon completion of the BREATHE-5 randomized, double-blind, placebo- controlled 16-week study.
- •For female patients, only non-pregnant women who are surgically sterile, postmenopausal or have documented infertility (over 50 years of age and amenorrheic for at least 1 year), or those of childbearing potential using one of the following methods of contraception: Barrier-type devices (e.g., condom, diaphragm) used ONLY in combination with a spermicide. A double-barrier method is recommended; intrauterine devices (IUDs); oral or implanted contraceptives, if used in combination with a barrier method.
- •Patients providing written informed consent.
排除标准
- •Patients who withdrew prematurely from BREATHE-5, AC-052-
- •Patients who are pregnant or nursing.
- •Patients who are receiving epoprostenol or prostacyclin analogues, or are expected to receive any of these drugs during the study.
- •Patients with AST and/or ALT values greater than 3 times the upper limit of normal.
- •Patients with hemoglobin or hematocrit that is more than 30% below the normal range (patients with secondary polycythemia are permitted in the study).
- •Patients with systolic blood pressure < 85 mm Hg.
- •Patients taking phosphodiesterase inhibitors, other endothelin receptor antagonists or are receiving another investigational product.
- •Patients active on organ transplant list.
- •Patients who are receiving or expected to receive glyburide, cyclosporin A or tacrolimus.
- •Patients not able to comply with the protocol or adhere to therapy.
研究组 & 干预措施
Tracleer
The starting dose for all patients will be 62.5 mg b.i.d. At the Week 4 visit, patients who were started on 62.5 mg b.i.d. will be uptitrated to 125 mg b.i.d. if the 62.5 mg b.i.d. dose was well-tolerated.
干预措施: Tracleer® (Drug)
结局指标
主要结局
Change in 6-minute Walk Distance
时间窗: from baseline to week 24
Change in Borg Dyspnea Index
时间窗: from baseline to week 24
Borg scale a numerical scale for assessing dyspnea, from 0 representing no dyspnea to 10 as maximal dyspnea.
Number of Participants With a Change in WHO Functional Class
时间窗: from baseline to week 24
Number of participants with a change in WHO functional class from baseline to week 24. A change from a higher to a lower functional class (i.e. III to II, III to I or II to I) is considered as an improvement.
次要结局
未报告次要终点