EUCTR2007-000446-12-GB进行中（未招募）不适用
Treatment of Pulmonary Hypertension and Sickle Cell Disease with Sildenafil Therapy - Walk PHaSST
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
- 132
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. Males or females, greater than or equal to 12 years of age and less than or
- •equal to 70 years of age
- •2. For female subjects, on a reliable method of birth control or not physically
- •able to bear children
- •3. Electrophoretic documentation of sickle cell disease (including, but not
- •limited to SS, SC, SD, or Sß°/+ thalassemia)
- •4. At least mild pulmonary hypertension with TRV = 2.7 m/s by
- •echocardiogram
- •5. Six minute walk distance of 150-500 m
- •6. In the opinion of the investigator, ability to complete the protocol scheduled
- •assessments during the 16 week, double-blind phase
- •7. Provision of informed consent and, where applicable, assent
- •8. Subjects with systemic hypertension must be on a stable antihypertensive
- •regimen for greater than or equal to 90 days and a stable dose for greater than
- •or equal to 30 days.
- •Are the trial subjects under 18? yes
- •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
- •1. Current pregnancy or lactation
- •2. Any one of the following medical conditions:
- •Stroke within the last six weeks
- •New diagnosis of pulmonary embolism within the last three months
- •History of retinal detachment or retinal hemorrhage in the last 6 months
- •Non-arteritic anterior ischemic optic neuropathy (NAION) in one or both eyes
- •History of sustained priapism requiring medical or surgical treatment, unless
- •currently impotent or on transfusion program within the last two years
- •Any unstable (chronic or acute) condition that in the opinion of the
- •investigator will prevent completion of the study
- •3. Subjects taking nitrate-based vasodilators (including, but not limited to
- •nicorandil [available in the UK only] ), prostacyclin (inhaled, subcutaneous or
- •intravenous) or endothelin antagonists. Subjects taking calcium channel
- •blockers will be allowed to participate provided they are on a stable dose for =
- •4. Left ventricular ejection fraction < 40% or clinically significant ischemic,
- •valvular or constrictive heart disease: LVEF <40% or SF < 22%
- •5. Subjects who are in other research studies with investigational drugs, with the
- •exception of hydroxyurea, unless the other trial has been approved by the
- •walk-PHaSST Executive Committee for co-participation
- •6. Acute or chronic impairment (other than dyspnea), limiting the ability to
- •comply with study requirements (in particular with 6MWT), e.g., angina
- •pectoris, intermittent claudication, symptomatic hip osteonecrosis
- •7. Tonsillectomies for sleep apnea within 3 months prior to randomization
- •8. Active therapy for pulmonary hypertension, including prostacyclin analog,
- •endothelin-1 antagonists, or PDE-5 inhibitor
- •9. Protease inhibitor therapy for the treatment of HIV
- •10. Subjects taking potent CYP3A4 inhibitor therapy (e.g., itraconazole, ritonavir,
- •ketoconazole)
- •11. Subjects who are anticoagulated and have proliferative retinopathy (unless
- •they have had ophthalmologist recommended intervention (e.g., phototherapy)
- •or have been otherwise cleared by an ophthalmologist to participate in the
- •12. Subjects with systolic blood pressure greater than or equal to 140 mmHg OR
- •diastolic blood pressure greater than or equal to 90 mmHg. See Section 9.3.3
- •for qualifying blood pressure assessment instructions.
研究者
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