EUCTR2010-019791-73-SK进行中（未招募）不适用
A randomized, double blind, placebo controlled, parallel group trial for assessing the clinical benefit of Dronedarone 400mg BID on top of standard therapy in patients with permanent atrial fibrillation and additional risk factors - Permanent Atrial fibriLLAtion outcome Study using Dronedarone on top of standard therapy (PALLAS)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10,800
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
- •Permanent AF defined by the presence of all of the following criteria:
- •- Availability of one 12-lead ECG not more than 14 days prior to randomization showing that the patient is in AF or atrial flutter
- •- Availability of documentation (including either rhythm strips or medical report of the rhythm) showing that the patient was in AF or atrial flutter at least 6 months prior to randomization
- •- No evidence of sinus rhythm in the period between these two documentations of AF
- •- Patient and physician decision to allow AF to continue without further efforts to restore sinus rhythm
- •Patients aged 65 years or older with at least one of the following risk criteria:
- •- Coronary artery disease
- •- Prior stroke or Transient Ischemic Attack (TIA)
- •- Symptomatic heart failure
- •- Left ventricular ejection fraction less or equal to 0.40
- •- Peripheral arterial occlusive disease
- •- Aged 75 years or older with both hypertension and diabetes mellitus
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Paroxysmal AF
- •- Persistent AF without a decision to allow AF to continue without further efforts to restore sinus rhythm
- •- Heart failure of New-York Heart Association (NYHA) class IV or recent unstable NYHA class III
研究者
相似试验
进行中（未招募）
不适用
A randomized, double blind, placebo controlled, parallel group trial for assessing the clinical benefit of Dronedarone 400mg BID on top of standard therapy in patients with permanent atrial fibrillation and additional risk factors - Permanent Atrial fibriLLAtion outcome Study using Dronedarone on top of standard therapy (PALLAS)MedDRA version: 14.0Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disordersAtrial FibrillationEUCTR2010-019791-73-DESanofi-aventis recherche & développement10,800
进行中（未招募）
1 期
Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.Moderate to Severe Ulcerative ColitisMedDRA version: 20.1Level: LLTClassification code 10066678Term: Acute ulcerative colitisSystem Organ Class: 100000004856EUCTR2018-003558-26-CZABIVAX232
进行中（未招募）
不适用
A randomized, double blind, placebo controlled, parallel groups, pilot study to assess the effects of two new nail lacquers, cyclosporine 5% and calcipotriol 0.005%, in the treatment of nail psoriasis - NDail psoriasisMedDRA version: 9.1Level: LLTClassification code 10028703EUCTR2010-019706-16-ITPOLICHEM
进行中（未招募）
不适用
A randomized, double blind, placebo controlled, parallel group, multicenter study of the safety and response rate of 3 subcutaneously administered doses of 5x10E7pfu RO5217790 in patients with high grade cervical intraepithelial neoplasia grade 2 or 3 associated with High Risk HPV infectioHigh grade cervical intraepithelial neoplasia grade 2 or 3 associated with High Risk HPV infectionMedDRA version: 9.1Level: LLTClassification code 10049701Term: Cervical intraepithelial neoplasia IIMedDRA version: 9.1Level: LLTClassification code 10049702Term: Cervical intraepithelial neoplasia IIIEUCTR2008-006946-24-DEF. Hoffmann-La Roche Ltd200
进行中（未招募）
不适用
A clinical study evaluating two different nail lacquers containing cyclosporine 5% and calcipotriol 0.005% in the treatment of nail psoriasis. A placebo (no active compound) will be used as control. Nor the investigator nor the patient will know the treatment applied.ail psoriasis of the nail matrix and / or the nail bed at fingernails (at least one should be affected)EUCTR2010-019706-16-LVPolichem SA75