JPRN-jRCT2080222891已完成3 期
A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality in Japanese Patients With Chronic Heart Failure and Reduced Ejection Fraction
ovartis Pharma K.K.0 个研究点目标入组 220 人开始时间: 2015年6月25日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 220
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
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Written informed consent must be obtained before any assessment is performed.
- •2. Outpatients with a diagnosis of CHF NYHA class II-IV and reduced ejection fraction:
- •-LVEF <= 35% at Visit 1 (any local measurement, made within the past 6 months using echocardiography, MUGA, CT scanning, MRI or ventricular angiography is also acceptable, provided no subsequent measurement above 35%)
- •-NT-proBNP >= 600 pg/ml at Visit 1 OR NT-proBNP >= 400 pg/ml at Visit 1 and a hospitalization for HF within the last 12 months (according to central laboratory measurements)
- •3. Patients must be on an ACEI or an ARB at a stable dose for at least 4 weeks before Visit 1.
- •4. Patients must be treated with a beta-blocker, unless contraindicated or not tolerated, at a stable dose for at least 4 weeks prior to Visit 1 (reason should be documented if patients reported contraindications or intolerance).
- •5. An aldosterone antagonist should also be considered in all patients, taking account of renal function, serum potassium and tolerability. If given, the dose of aldosterone antagonist should be optimized according to guideline recommendations and patient tolerability, and should be stable for at least 4 weeks prior to Visit 1. Other evidence-based therapy for HF should also be considered e.g. cardiac resynchronization therapy and an implantable cardioverter-defibrillator in selected patients, as recommended by guidelines.
排除标准
- •1. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes, ACEIs, ARBs, NEP inhibitors as well as known or suspected contraindications to the study drugs.
- •2. Previous documented history of intolerance to ACEIs or ARBs.
- •3. Known history of angioedema.
- •4. Requirement of treatment with both ACEIs and ARBs.
- •5. Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy).
- •6. Symptomatic hypotension and/or a SBP < 100 mmHg at screening or < 95 mmHg at the end of run-in.
- •7. Estimated GFR < 30 mL/min/1.73 m2 as measured by the Japanese formula at screening, or the end of run-in or > 35% decline in eGFR between screening and end of run-in (according to local measurements).
- •8. Serum potassium > 5.2 mmol/L (mEq/L) at screening or > 5.4 mmol/L (mEq/L) at the end of run-in (according to local measurements).
- •9. Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major CV surgery, percutaneous coronary intervention (PCI) or carotid angioplasty within the 3 months prior to Visit 1.
- •10. Documented untreated ventricular arrhythmia with syncopal episodes within the 3 months prior to Visit 1.
- •11. Symptomatic bradycardia or second (except asymptomatic Wenckebach block) or third degree heart block without a pacemaker.
- •12. Presence of hemodynamically significant mitral and/or aortic valve disease, except mitral regurgitation secondary to left ventricular dilatation.
- •13. Presence of other hemodynamically significant obstructive lesions of left ventricular outflow tract, including aortic and sub-aortic stenosis.
- •14. Presence of bilateral renal artery stenosis.
- •Other protocol defined inclusion/exclusion criteria may apply.
研究者
相似试验
进行中（未招募）
1 期
Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet SyndromeDravet's syndromeMedDRA version: 18.1Level: LLTClassification code 10073682Term: Dravet syndromeSystem Organ Class: 100000004850EUCTR2015-004167-37-NOZogenix International Limited260
进行中（未招募）
1 期
Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet SyndromeDravet syndromeMedDRA version: 20.0Level: LLTClassification code 10073682Term: Dravet syndromeSystem Organ Class: 100000004850EUCTR2015-004167-37-ITZOGENIX INTERNATIONAL LTD260
进行中（未招募）
1 期
A study to evaluate the effect of Benralizumab in Patients with Severe Asthma Uncontrolled.severe uncontrolled asthmaMedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 20.0Level: LLTClassification code 10049106Term: Asthma chronicSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2017-001040-35-BEAstraZeneca AB630
进行中（未招募）
1 期
A Study Comparing Sirukumab (CNTO 136) Monotherapy with Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid ArthritisMedDRA version: 17.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersRheumatoid ArthritisEUCTR2013-001417-32-HUJanssen-Cilag International N.V.510
进行中（未招募）
1 期
A study to evaluate the effect of Benralizumab in Patients with Severe Asthma Uncontrolled.severe uncontrolled asthmaMedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 20.0Level: LLTClassification code 10049106Term: Asthma chronicSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2017-001040-35-NLAstraZeneca AB630