EUCTR2008-003482-68-ES进行中（未招募）1 期
Ensayo clínico, multinacional, multicéntrico, aleatorizado ,doble ciego, controlado con placebo, para evaluar la eficacia y la seguridad de BAY 63-2521 (1 mg, 1.5 mg, 2mg, o 2.5 mg ,tid )administrado por vía oral, en pacientes con Hipertensión Arterial Pulmonar (HAP) sintomática-Estudio PATENT -1 Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
入选标准
- •- Male and female patients with symptomatic PAH ( Group I / Venice Clinical Classification of Pulmonary Hypertension), a 6MWD test between 150 m and 450 m, a pulmonary vascular resistance (PVR) >300 dyn*sec*cm-5 and a mean pulmonary artery pressure (PAPmean) >25 mmHg either due to:
- •-Idiopathic PAH
- •- Familial PAH
- •- Associated PAH due to connective tissue disease
- •- Associated PAH due to congenital heart disease (ie atrial septal defect, ventricle septal defect, persistent ductus arteriosus), if patients underwent surgical correction more than 12 months before study inclusion
- •- Associated PAH due to portal hypertension with liver cirrhosis CHILD-Pugh class A (B and C excluded) and proven alcohol abstinence for >6 months and no active hepatitis
- •- Associated PAH due to anorexigen or amphetamine use
- •- Treatment naive patients (with respect to PAH specific medication) and patients pre-treated with an Endothelin Receptor Antagonist or a Prostacyclinanalogue*:
- •- Pretreated Patients need to be stable on Endothelin Receptor Antagonists or Prostacyclin treatment for at least three months prior toVisit 1. Stable is defined as no change in the type of Endothelin Receptor Antagonists or Prostacyclinanalogue and the respective daily dose.
- •NOTE: In Spain the inclusion of treatment naïve patients is not allowed.
- •- Unspecific treatments which may also be used for the treatment of pulmonary hypertension such as oral anticoagulants, diuretics, digitalis, low to medium dose calcium channel blockers or oxygen supplementation are permitted. However, treatment with anticoagulants must have been started at least 3 months before Visit 1 and treatment with diuretics needs to be stable for at least one month before Visit 1.
- •- Patients who full-fill criteria for a supplemental long-term oxygen therapy (PaO2 < 55 mmHg and/or SaO2 < 88% at rest, sleep and exertion) need to be supplied sufficiently before study entry. The amount of supplemental oxygen and the delivery method need to be stable for at least three months before Visit 1.
- •- Right-heart catheterization results for the definite diagnosis of PH must not be older than 6 weeks at Visit 1 (will be considered as baseline values), must have been measured after at least 3 months of full anticoagulation, and must have been measured in the participating centre under standardized conditions (refer to the study specific Swan Ganz catheterization manual). If the respective measurements have not been performed in context with the patient?s regular diagnostic work up, they have to be performed as a part of the study during the Pre-Study Phase (after the patient signed the informed consent).
- •- 18 to 75 years of age at Visit 1.
- •- Women without childbearing potential defined as postmenopausal women aged 55 years or older, women with bilateral tubal ligation, women with bilateral ovarectomy, and women with hysterectomy can be included in the study. Women with childbearing potential can only be included in the study if a serological pregnancy test is negative and a combination of condoms with a safe and highly effective contraception method (hormonal contraception with implants or combined oral contraceptives, certain IUDs) is used.
- •- Patients who are able to understand a
排除标准
- •- Participation in another clinical trial during the preceding 3 months.
- •- Pregnant women, or breast feeding women, or women with childbearing potential not using a combination of condoms and a safe and highly effective contraception method (hormonal contraception with implants or combined oral contraceptives, certain IUDs)
- •- Patients with a medical disorder, condition, or history of such that would impair the patient's ability to participate or complete this study in the opinion of the investigator
- •- Patients with underlying medical disorders with an anticipated life expectancy below 2 years (eg active cancer disease with localized and/or metastasized tumor mass)
- •- Patients with a history of severe allergies or multiple drug allergies.
- •- Patients with hypersensitivity to the investigational drug or inactive constituents.
- •- Patients unable to perform a valid 6MWD test (eg orthopedic disease, peripheral artery occlusive disease, which affects the patient´s ability to walk)
- •- Patients with a variance of more than 15% between the eligibility- and the baseline 6MWD test
- •Medication/Treatment Exclusions:
- •Patients who are screened for possible participation in the study must not been
- •withdrawn from treatments which are medically required. If such treatments are not
- •in-line with the entry criteria of this study, the patient must not be enrolled.
- •The following specific medications for treatment of pulmonary hypertension or
- •medications which may exert a pharmacodynamic interaction with the study drug
- •are not allowed:
- •Pre-Treatment within the last 3 months before Visit 1:
- •- iv Prostacycline Analogues.
- •- Specific (eg Sildenafil or Tadalafil) or unspecific Phosphodiesterase Inhibitors
- •(eg Dipyridamole, Theophylline).
- •- NO donors (eg Nitrates).
- •Pulmonary Diseases Exclusions:
- •- All types of pulmonary hypertension except subtypes of Venice Group I
- •specified in the inclusion criteria.
- •- Moderate to severe bronchial asthma or COPD (Forced Expiratory Volume <
- •60% predicted).
- •- Severe restrictive lung disease (Total Lung Capacity < 70% predicted).
- •- Severe congenital abnormalities of the lungs, thorax, and diaphragm.
- •- Clinical or radiological evidence of Pulmo-Veno-Occlusive Disease (PVOD) or
- •Pulmonary Capillary Haemangiomatosis (PCH).
- •Exclusions related to abnormalities in blood gases (measured capillary or arterial):
- •- SaO2 < 88% despite supplemental oxygen therapy.
- •- PaO2 < 55 mmHg despite supplemental oxygen therapy.
- •- PaCO2 > 45 mmHg.
- •Cardiovascular Exclusions:
- •- Uncontrolled arterial hypertension (Systolic blood pressure >180 mmHg and /or
- •diastolic blood pressure >110 mmHg).
- •- Systolic blood pressure <95 mmHg.
- •- Resting heart rate in the awake patient <50 BPM or >105 BPM.
- •- History of atrial fibrillation within the last 3 months before Visit 1.
- •- Left heart failure with an ejection fraction less than 40%.
研究者
相似试验
进行中（未招募）
1 期
Ensayo clínico, multinacional, multicéntrico, aleatorizado ,doble ciego, controlado con placebo, para evaluar la eficacia y la seguridad de BAY 63-2521 (1 mg, 1.5 mg, 2mg, o 2.5 mg,tid), administrado por vía oral, en pacientes con Hipertensión Pulmonar Tromboembólica Crónica (HPTEC). Estudio CHEST ?1 Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-1 StudyEUCTR2007-000072-16-ESBayer HealthCare AG
进行中（未招募）
不适用
Ensayo clínico prospectivo, multinacional, multicéntrico, aleatorizado, doble ciego, doble simulación, que compara la eficacia y la seguridad de moxifloxacino respecto a amoxicilina/ácido clavulánico en el tratamiento de pacientes con exacerbaciones agudas de bronquitis crónica”Estudio MAESTRAL. (A prospective, multinational, multicenter, randomized, double-blind, double-dummy, controlled study comparing the efficacy and safety of moxifloxacin to that of amoxicillin-clavulanic acid for the treatment of subjects with acute exacerbations of chronic bronchitis: MAESTRAL (moxifloxacin in AECB superiority trial) - MAESTRAEUCTR2007-006096-37-ESBayer HealthCare AG, Leverkusen, Germany1,786
进行中（未招募）
1 期
Ensayo clínico multinacional, aleatorizado, doble ciego, controlado con placebo y control activo, de grupos paralelos para comparar la eficacia y seguridad, a lo largo de 24 semanas, de 3 dosis de BEA 2180 BR (50 µg, 100 µg, 200 µg) con tiotropio 5 µg y placebo administrados con el inhalador Respimat® en pacientes con Enfermedad Pulmonar Obstructiva Crónica (EPOC).Enfermedad Pulmonar Obstructiva Crónica (EPOC)MedDRA version: 9.1Level: PTClassification code 10009033Term: Chronic obstructive pulmonary diseaseEUCTR2007-001946-42-ESBoehringer Ingelheim España, S.A.1,950
进行中（未招募）
不适用
Ensayo clínico multinacional, abierto, aleatorizado, de grupos paralelos, para comparar la eficacia y la seguridad de insulina detemir (Levemirâ) frente a insulina humana (insulina NPH), usada en combinación con insulina aspart como insulina en bolo, en el tratamiento de mujeres embarazadas con diabetes tipo 1EUCTR2006-004861-33-ESovo Nordisk A/S407
进行中（未招募）
1 期
Estudio multinacional, multicéntrico, randomizado, doble ciego, de grupos paralelos, controlado con placebo, para evaluar la seguridad, tolerabilidad y eficacia de la administración oral de laquinimod 0,6mg una vez al día en pacientes con esclerosis múltiple remitente recurrente (RRMS). - AllegroEsclerosis Múltiple Remitente Recurrente (RRMS)MedDRA version: 9.1Level: PTClassification code 10028245Term: Multiple sclerosisEUCTR2007-003226-19-ESTeva Pharmaceutical Industries Ltd1,000