EUCTR2016-001412-38-DE进行中（未招募）1 期
A randomized, parallel-group, placebo-controlled subject and investigator blinded study to assess the safety, tolerability, pharmacokinetics and efficacy of QCC374 in the treatment of pulmonary arterial hypertension
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 8
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
- •Male and female patients 18 years of age or older with symptomatic PAH.
- •Subjects with PAH belonging to one of the following subgroups of the Updated Clinical Classification Group 1 (Nice, 2013):
- •Idiopathic PAH
- •familial PAH
- •PAH associated with connective tissue disease, congenital heart disease (surgically repaired at least 12 months prior to screening) or drug or toxin induced (for example, anorexigen use).
- •Subjects must have persistent symptoms due to PAH despite therapy with at least one of
- •the following PAH medications: an endothelin receptor antagonist, asoluble guanylate cyclase stimulator or a phosphodiesterase inhibitor. The subjects' PAH medication regimen, with typical medications including calcium channel blockers, endothelin receptor antagonists, soluble guanylate cyclase stimulators and/or phosphodiesterase inhibitors, must have been used at a stable dose and frequency for at least 12 weeks before the screening visit and during the screening period.
- •Diagnosis of PAH established according to the standard criteria before the screening visit:
- •Resting mean pulmonary arterial pressure = 25 mmHg.
- •PVR > 240 dynes s/cm5.
- •Pulmonary capillary wedge pressure or left ventricular end diastolic pressure = 15 mmHg
- •PVR > 400 dynes s/cm5 at the time of the baseline right heart catheterization (RHC) (if a RHC was completed within one month of the screening visit, that result may be used for inclusion).
- •6-minute walk distance greater than 150 meters at Screening. This distance must be confirmed by a second 6MWT prior to randomization. The value of the second 6MWD should be within ± 15% of the value obtained at Screening.
- •Other protocol-defined inclusion criteria may apply.
- •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 34
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •Subjects with clinically unstable right heart failure within the last three months (New York Heart Association (NYHA) Class IV).
- •Subjects with PAH associated with portal hypertension, Human Immunodeficiency Virus
- •(HIV) infection or unrepaired congenital systemic to pulmonary shunts or subjects with PAH responsive to high dose calcium channel blockers.
- •Subjects who have received or have been scheduled to receive long-term treatment with
- •epoprostenol or any prostacyclin within the three months prior to the screening visit or during the screening period.
- •Hypotensive subjects (systemic systolic blood pressure < 85 mmHg)
- •Subjects with left sided heart disease, chronic left sided heart failure, congenital or acquired valvular disease and/or pulmonary venous hypertension, as determined by history or echocardiogram at baseline visit.
- •Subjects with obstructive (FEV1/ FVC < 70% predicted and FEV1 < 70% predicted) or restrictive (total lung capacity < 65% predicted and/or clinically significant abnormality on CXR) lung disease at screening.
- •Other protocol-defined exclusion criterias may apply.
研究者
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