NCT00494533终止4 期
Treprostinil for Untreated Symptomatic PAH Trial: A 12-Week Multicenter Randomized Double-Blind Placebo-Controlled Trial of the Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension
United Therapeutics14 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2005年3月最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 45
- 试验地点
- 14
- 主要终点
- Six-minute walk distance
研究概览
简要总结
Multi-center, double-blind, placebo-controlled, randomized, parallel study comparing continuous intravenous (IV) Remodulin® to placebo in patients with pulmonary arterial hypertension either primary (PPH) or associated with human immunodeficiency virus (HIV) infection or collagen vascular disease).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients Must
- •Between 16- 75 years of age.
- •Male or, if female, physiologically incapable of childbearing or utilizing birth control.
- •Have current diagnosis of symptom-limited NYHA Functional Class III/IV PAH that is:
- •PPH ("idiopathic" or familial PAH); or
- •PAH associated with collagen vascular disease (confirmed by antinuclear antibody titer or acceptable test); or
- •PAH associated with HIV infection (confirmed by serological test).
- •If HIV positive, have CD4 lymphocyte count ≥ 200 at baseline and receiving current SOC anti-retroviral or effective medication for HIV infection.
- •Optimally treated with conventional PH therapy and clinically stable for at least 1 month prior to baseline.
- •Have ventilation/perfusion scan, contrast-enhanced CT scan, or pulmonary angiogram after onset of PAH that rules out pulmonary embolism.
- •Have cardiac catheterization in last 3 months (or at Baseline) showing:
- •PAPm > 35 mmHg (at rest) &
- •PCWPm (or LV end diastolic pressure) < 16 mmHg &
- •PVR > 5 mmHg/L/min.
- •Have echocardiogram in last 3 months consistent with PH, specifically:
- •evidence of RV hypertrophy or dilation &
- •evidence of normal LV function &
- •absence of mitral valve stenosis.
- •Have chest radiograph consistent with PH performed in last 3 months. Radiograph must show clear lung fields or no more than patchy interstitial infiltrates.
- •Unless contraindicated, able to receive one of following anticoagulants: warfarin to achieve INR between 1.5-2.5 or heparin to produce aPTT between 1.3-1.5 times control, unless higher levels clinically indicated.
- •Mentally and physically capable of learning to administer Study Drug using ambulatory intravenous infusion pump and central venous access, or have trained caregiver.
- •If on corticosteroids, receiving stable dose of 20 mg/day of prednisone (or equivalent dose of another steroid) for at least 1 month prior to entry.
排除标准
- •Patients must not:
- •Nursing or pregnant (women of childbearing potential have negative pregnancy test).
- •Have had new type of chronic therapy (including but not limited to oxygen, different category of vasodilator, diuretic, digoxin) for PH, except for anticoagulants, added in last month.
- •Be scheduled for heart-lung transplant.
- •Have any PH medication except for anticoagulants discontinued in week prior to study entry.
- •Have received any chronic prostaglandin or prostaglandin analogue (including intravenous/inhaled/oral: epoprostenol, iloprost, beraprost, etc.), any phosphodiesterase inhibitor therapy such as sildenafil, or any endothelin antagonist therapy such as bosentan, in past 30 days.
- •Have PH associated with chronic thromboembolic disease; or chronic obstructive lung diseases or hypoxemia; or evidence of significant parenchymal lung disease as evidenced by PFTs in last 3 months as follows (any one of following):
- •TLC < 60% (predicted) or high resolution CT documenting diffuse interstitial fibrosis or alveolitis
- •FEV1/FVC ratio < 50%
- •Have Portal Hypertension.
- •Have history of uncontrolled Sleep Apnea, defined as oxygen desaturation less than 90% at night, in past 3 months.
- •Have history of left-sided heart disease including:
- •Aortic or mitral valve disease or
- •Pericardial constriction or
- •Restrictive or congestive cardiomyopathy; or have evidence of current left-sided heart disease defined by:
- •PCWPm or LV end diastolic pressure > 16 mmHg or
- •LVEF < 40% by MUGA, angiography or echocardiography or
- •LV Shortening Fraction < 22% by echocardiography or
- •Symptomatic coronary disease (demonstrable ischemia).
- •Have any disease other than HIV or connective tissue disease associated with PH (e.g. sickle cell anemia, schistosomiasis).
- •Have active AIDS or tuberculosis.
- •Have musculoskeletal disorder (e.g. arthritis, artificial leg, etc.) or any other disease thought to limit ambulation, or connected to machine which is not portable.
- •Have baseline exercise capacity of <50 m or >325 m as measured by 6-Minute Walk Test.
- •Have uncontrolled systemic hypertension as evidenced by systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg.
- •Have used prescription appetite suppressants in 3 months of study entry.
- •Have chronic renal insufficiency defined by creatinine >2.5 mg/dL or requiring dialysis.
- •Receiving an investigational drug (other than acute challenge with epoprostenol), have in place an investigational device, or have participated in investigational drug/device study in past 30 days.
- •Have presence of any physiological or mental condition which contraindicates administration of Remodulin.
结局指标
主要结局
Six-minute walk distance
时间窗: Twelve Weeks
Placebo-corrected change in 6-minute walk distance from Baseline to Week 12.
次要结局
- Borg Dyspnea Score(Twelve Weeks)
- Dyspnea-Fatigue Index(Twelve weeks)
- NYHA Functional Class(Twelve Weeks)
- Clinical Worsening(Twelve Weeks)
- Combined Walk and Borg Dyspnea Score(12 Weeks)
研究者
研究点 (14)
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