EUCTR2022-001854-49-NL进行中（未招募）1 期
Multi-Centre, Placebo-Controlled, Phase 2 Study of Etripamil Nasal Spray (NS) for the Reduction of Ventricular Rate in Patients with Atrial Fibrillation
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged 18 years and over
- •2. Has provided written informed consent
- •3. Patients with episodes of paroxysmal, persistent or permanent AF,
- •presenting with AF and a ventricular rate =110 bpm measured over
- •4. Patients should receive appropriate antithrombotic therapy as per
- •the applicable guidelines for AF management (e.g. Canadian
- •Cardiovascular Society (CCS) / European Society of Cardiology
- •(ESC) guidelines).
- •a. Etripamil (a calcium channel blocker) is intended for acute
- •rate control only. If rhythm control is desired (outside of
- •the present protocol), anticoagulation as per guidelines may
- •start after the administration of study drug.
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1. Has evidence of atrial flutter (ECG) at presentation
- •2. Has a history of stroke, transient ischemic attack or peripheral
- •embolism within the last 3 months
- •3. Has received by IV route any of the following within one hour
- •before study drug administration: flecainide, procainamide,
- •digoxin, beta-blocker, or calcium channel blocker
- •4. Has signs and symptoms of severe congestive heart failure at
- •presentation (e.g. tachypnea, oxygen desaturation <90% unless due
- •to known pulmonary disease, pulmonary rales, sign of peripheral
- •hypoperfusion)
- •5. Hemodynamic instability, with systolic blood pressure <90 mmHg
- •or diastolic blood pressure <60 mmHg
- •6. Known uncorrected severe aortic or mitral stenosis
- •7. Hypertrophic cardiomyopathy with outflow tract obstruction
- •8. Has a history of second- or third-degree atrioventricular block
- •9. Regular rhythm suggesting a complete AV block
- •10. Has a history or evidence of torsades de pointes, sick sinus
- •syndrome, or Brugada syndrome
- •11. Evidence of Acute Coronary Syndrome within the last 12 months
- •except if patient was successfully revascularized
- •12. Positive pregnancy test result at screening, and females of
- •childbearing potential who do not agree to use adequate method of
- •contraception for the duration of the study.
- •13. Has evidence of any clinically significant acute or chronic condition
- •of the nasal cavity (e.g., rhinitis or deviated septum) which could
- •interfere with administration of the study drug in either or both
- •nasal cavities
- •14. Has a history of sensitivity to verapamil
- •15. Has previously participated in a clinical study for etripamil
- •16. Has a history of sensitivity to any components of the investigational
- •17. Signs of alcohol or drug intoxication at the time of presentation
- •which, in the opinion of the Investigator, would impact the validity
- •of study results
- •18. Is currently participating in another drug or device study, or has
- •received an investigational drug or device within 30 days of
- •19. Has evidence of clinically significant cardiovascular, endocrine,
- •gastrointestinal, hematologic, hepatic, immunologic, neurologic,
- •oncologic, pulmonary, psychiatric, or renal disease or any other
- •condition which, in the opinion of the Investigator, would
- •jeopardize the safety of the patient or impact the validity of study
研究者
相似试验
已完成
2 期
Multi-Centre, Placebo-Controlled, Phase 2 Study of Etripamil Nasal Spray (NS) for the Reduction of Ventricular Rate in Patients with Atrial FibrillatioarrhythmiaNL-OMON51562Milestone Pharmaceuticals50
进行中（未招募）
1 期
A Multi-Centre, Placebo-Controlled Phase II Study of Canakinumab for the Treatment of Adult-onset Still's disease (AOSD) including an open-label long term extension.adult onset Still's disease (AOSD)MedDRA version: 20.0Level: PTClassification code 10042061Term: Still's diseaseSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2011-001027-20-DECharité - Universitätsmedizin Berlin36
进行中（未招募）
不适用
A clinical study to investigate the safety and efficacy of ATH008 cream in the treatment of the hand-foot syndrome (Palmar-Plantar Erythrodysesthesia – PPES) caused by chemotherapy with capecitabine.Palmar-Plantar Erythrodysesthesia Syndrome (PPES)MedDRA version: 16.0Level: LLTClassification code 10054524Term: Palmar-plantar erythrodysesthesia syndromeSystem Organ Class: 100000004858EUCTR2010-022439-12-DEAdvancell Advanced In Vitro Cell Technologies, S.A114
进行中（未招募）
1 期
A Phase II Placebo Controlled, Multicenter Study to Investigate the Safety and Efficacy of ATH008 cream in Patients with hand and foot syndrome secondary to capecitabine chemotherapy.Palmar-Plantar Erythrodysesthesia Syndrome (PPES)MedDRA version: 14.1Level: LLTClassification code 10054524Term: Palmar-plantar erythrodysesthesia syndromeSystem Organ Class: 100000004858EUCTR2010-022439-12-BEAdvancell Advanced In Vitro Cell Technologies, S.A114
已完成
2 期
A study of the safety of 3 months treatment with BIT225, in combination with pegylated interferon and ribavirin, in patients with chronic hepatitis C infection, compared to pegylated interferon and ribavirin alone, including measurement of the concentration of BIT225 in the blood and antiviral activity.Hepatitis C Virus InfectionInfection - Other infectious diseasesOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colonACTRN12613001296729Biotron Limited60