NCT00004497已完成3 期
Phase III Randomized Study of UT-15 in Patients With Primary Pulmonary Hypertension
United Therapeutics7 个研究点 分布在 1 个国家开始时间: 1998年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 试验地点
- 7
研究概览
简要总结
OBJECTIVES:
I. Determine the safety and efficacy of UT-15 in patients with severe symptomatic primary pulmonary hypertension.
详细描述
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are stratified according to center and etiology of disease.
Patients receive conventional oral therapy plus a continuous subcutaneous infusion of either UT-15 or placebo for 12 weeks.
After completing 12 weeks of treatment, patients may continue therapy with open label UT-15. Patients who received placebo cross over to receive UT-15.
Completion date provided represents the completion date of the grant per OOPD records
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 8 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PROTOCOL ENTRY CRITERIA:
- •-Disease Characteristics--
- •Diagnosis of moderate to severe precapillary pulmonary hypertension (New York Heart Association class III/IV) unresponsive to attempted use of chronic oral vasodilators for at least 1 month
- •Cardiac catheterization at baseline: Pulmonary artery pressure at least 25 mm Hg AND Pulmonary capillary wedge pressure or left ventricular end diastolic pressure no greater than 15 mm Hg AND Pulmonary vascular resistance greater than 3 mm Hg/L/min
- •Echocardiogram at baseline: Right ventricular hypertrophy or dilation AND Normal left ventricular function AND Absence of mitral valve stenosis
- •Chest radiograph within prior 3 months Clear lung fields OR Multiple patchy interstitial (not diffuse) lung fields AND At least 1 of the following:
- •Right ventricular enlargement
- •Prominence of main pulmonary artery
- •Enlarged hilar vessels
- •Decreased peripheral vessels
- •No significant parenchymal lung disease within prior 3 months as evidenced by: Total lung capacity no greater than 70% predicted FEV/FVC ratio no greater than 50% Diffuse interstitial fibrosis or alveolitis by high resolution CT if total lung capacity is 70-80% or DLCO less than 60%
- •No chronic thromboembolic disease with clot proximal to lobar bifurcation
- •Baseline exercise capacity at least 50 meters walked in six minutes
- •-Prior/Concurrent Therapy--
- •Endocrine therapy:
- •At least 30 days since prior chronic prostaglandin or prostaglandin analogue therapy (including Flolan IV)
- •No concurrent prostaglandins or prostaglandin analogues
- •At least 1 month since prior new type of chronic therapy (e.g., different category of vasodilator, diuretic, digoxin) for pulmonary hypertension, except anticoagulants
- •At least 1 week since discontinuation of prior pulmonary hypertension medication, except anticoagulants
- •At least 30 days since prior participation in an investigational drug study
- •No other concurrent investigational drug
- •No concurrent chronic intravenous or inhaled medications (except oxygen)
- •-Patient Characteristics--
- •Cardiovascular:
- •No portal hypertension
- •No left sided heart disease as defined by: Pulmonary capillary wedge pressure or left ventricular end diastolic pressure greater than 15 mm Hg OR LVEF less than 40% by MUGA or angiography OR LV shortening fraction less than 22% by echocardiography OR Symptomatic coronary disease (demonstrable ischemia)
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Mentally and physically capable of using an infusion pump
- •HIV negative
- •No other disease associated with pulmonary hypertension (sickle cell anemia, schistosomiasis)
- •No musculoskeletal disorder (arthritis, artificial leg, etc.) or any disease limiting ambulation, or connected to a nonportable machine
- •No concurrent physiological condition contraindicating use of UT-15
排除标准
- 未提供
研究者
研究点 (7)
Loading locations...
相似试验
终止
1 期
An Open Study Assessing the Safety and Tolerability of U3-1784Advanced Solid TumorsHepatocellular Cancer (HCC)NCT02690350Daiichi Sankyo10
已完成
1 期
Three Times Daily Dosing of UT-15CHealthyNCT01746485United Therapeutics19
已完成
3 期
The MM5 trial: evaluation of two regimens of bortezomib-based induction therapy and of lenalidomide consolidation followed by lenalidomide maintenance treatment in patients with multiple myelomaMultiple myeloma and malignant plasma cell neoplasmsCancerMultiple myelomaISRCTN05622749niversity Hospital Heidelberg (Universitätsklinikum Heidelberg) (Germany)504
终止
3 期
Crossover Study to Assess the Efficacy and Safety of UX007 in the Treatment of Movement Disorders Associated With Glucose Transporter Type 1 Deficiency Syndrome (Glut1 DS)Glucose Transporter Type 1 Deficiency Syndrome (Glut1 DS)NCT02960217Ultragenyx Pharmaceutical Inc44
进行中（未招募）
1 期
Safety, Tolerability, and Efficacy of IL-15 Superagonist (N-803) With and Without Combination Broadly Neutralizing Antibodies to Induce HIV-1 Control During Analytic Treatment InterruptionHIV InfectionNCT04340596National Institute of Allergy and Infectious Diseases (NIAID)118