EUCTR2011-002018-35-IT进行中（未招募）不适用
SPHERIC-1OE (Sildenafil and Pulmonary HypERtension In COPD – Open Extension) - A multicenter, longitudinal, 12 months open-label study, for the observation of the use of sildenafil in the treatment of patients with pulmonary hypertension associated to chronic obstructive lung disease enrolled in SPHERIC-1 study - SPHERIC-1 OPEN EXTENSIO
ASSOCIAZIONE ITALIANA PNEUMOLOGI OSPEDALIERI0 个研究点开始时间: 2012年10月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Patients enrolled in the study SPHERIC-1 who completed the study with stable COPD in optimal pharmacological treatment (Eur Respir J 2004; 23: 932-946), chronic oxygen therapy in patients with hypoxia, with PaO2 at rest = 60 mmHg and PaCO2 = 55 mmHg, aged between 18 and 80 years old
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Exlusion criteria as previous study SPHERIC-1: • Different types of pulmonary hypertension (chronic,
- •thromboembolic pulmonary hypertension, pulmonary arterial
- •hypertension etc.) • Significant left cardiac disease (LVEF <45%,
- •cardiomyopathy, valvulopathy, unstable coronaropathy) •
- •Treatment with nitrates in the last 10 days, or in need of other
- •nitrate therapy for different diseases • Treatment with other
- •specific drugs for arterial pulmonary hypertension (less than 4
- •weeks) • Significant systemic disease other than COPD • Recent
- •reacutization of chronic bronchitis (< 4 weeks) • Pregnancy or
- •breastfeeding, or women without an adequate contraceptive
- •method for the whole study duration • History of anaphylaxys or
- •allergic reactions to 5-phosphodiesterase inhibitors • Cancers
- •within the last 5 years with the exception of localized cancers of
- •the skin or of the cervix • Hepatic insufficiency or chronic renal
- •failure or hemoglobinemia < 10 g/dL during the screening phase •
- •Contraindications to subministration as per SPC • Mental disorder,
- •alcohol abuse, chronic alcoholism, drug abuse • Subjects unable to
- •sign the informed consent form • Subjects unable to walk
研究者
相似试验
已完成
不适用
Clinical efficacy of sildenafil on pulmonary hypertension in patinets with chronic respiratory disordersChronic respiratory diseases, Chronic obstructive pulmonary disease (COPD), Chronic respiratory failure pulmonary hypertensionJPRN-UMIN000003107ational Hospital Organization, Tokyo National Hospital30
进行中（未招募）
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SPHERIC-1 (Sildenafil in the Chronic Obstructive Pulmonary Disease associated to Chronic Pulmonary Hypertension. Sixteen weeks long, multicentre, randomized, double blind study, in comparison with placebo, for the evaluation of sildenafil in the treatment of patients affected by pulmonary hypertension associated to COPD. - SPHERIC-1Moderate to severe pulmonary hypertension associated to moderate to mild COPD.MedDRA version: 14.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 14.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2010-020917-97-ITASSOCIAZIONE ITALIANA PNEUMOLOGI OSPEDALIERI
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Effects of Sildenafil on pulmonary artery pressure in patients with heart failure with preserved ejection fraction and pulmonary hypertensiodisturbed relaxation of the heartheart failure with preserved ejection fraction10019280NL-OMON38270niversitair Medisch Centrum Groningen52
进行中（未招募）
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Effects of Sildenafil on pulmonary artery pressure in patients with heart failure with preserved ejection fraction and pulmonary hypertension - Sildenafil in HFpEF and PHThe condition to be investigated is isolated left heart failure , also called heart failure with preserved ejection fraction ( HFpEF) with pulmonary hypertension. HFpEF is a clinical syndrome with severe symptoms and high mortality. The presence of PH in HFpEF is associated with increased mortality . Nevertheless there is no evidence based medical treatment regiment for this condition.EUCTR2010-020153-14-NLniversity Medical Center Groningen52
已完成
2 期
Role of sildenafil in secondary pulmonary hypertension due to chronic obstructive pulmonary disease.CTRI/2009/091/000017self40