A Phase Ⅲ Study of Extended-Release Carvedilol Sulfate for the Treatment of Heart Failure
NCT ID: NCT02012075
Last Updated: 2013-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
316 participants
INTERVENTIONAL
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Extended-Release Carvedilol Sulfate
18-72mg/d,po
Extended-Release Carvedilol Sulfate
Sustained-release Metoprolol Succinate
11.875-190mg/d,po
Sustained-release Metoprolol Succinate
Interventions
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Extended-Release Carvedilol Sulfate
Sustained-release Metoprolol Succinate
Eligibility Criteria
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Inclusion Criteria
* Aged from 18 to 75 years
* New York Heart Association(NYHA) classification Ⅱ-Ⅲ
* At screening, subject has an LVEF\<0.45
* Have received optimal therapy with an Angiotensin converting enzyme inhibitors or angiotensin receptor blocker for 4 weeks before enrollment
* Subjects with symptoms of Stable heart failure do not need intravenous injection diuretics,cardiac inotropes or vasodilators
* Willing to provide written informed consent
Exclusion Criteria
* Current treatment on calcium antagonists except for long-acting dihydropyridine agents
* Have a history of acute coronary syndrome,cerebral apoplexy or transient ischemic attack with 3 months
* Have a history of cardio-vascular surgery or other vessel operations with 3 months
* Have a history of sustained ventricular tachycardia or ventricular fibrillation with 3 months
* Have a plan to receive coronary revascularization or heart transplantation
* Uncontrolled ventricular arrhythmias (not controlled with antiarrhythmic therapy or an implantable defibrillator)
* Subjects with uncorrected primary obstructive or severe regurgitative valvular disease，nondilated (restrictive) or hypertrophic cardiomyopathy
* Sitting systolic blood pressure≤90mmHg (based on an average of 3 readings)
* Current decompensated heart failure
* Second or third degree heart block，or sick sinus syndrome，a pacemaker is not placed
* Contraindication to vasodilators
* Have a history of cardiac resynchronization therapy or
* Have received cardioverter defibrillator or pacemaker with 1 month
* Resting heart rate\<50 beats per minute(based on the average of 3 readings)
* Elevated liver enzymes (alanine aminotransferase or aspartate aminotransferase levels greater than 3 times upper limit of normal)
* Serum creatinine levels greater than 2 times upper limit of normal
* Current clinical evidence of obstructive pulmonary disease (e.g., asthma or bronchitis) requiring inhaled or oral bronchodilator or steroid therapy
* History of drug sensitivity or allergic reaction to alpha or beta-blockers
* Contraindication or intolerance to beta-blockers
* Pregnant or lactating women and women planning to become pregnant
* Has any systemic disease, including cancer, with reduced life expectancy (\<12 months)
* Use of an investigational drug within 30 days of enrollment
* Participation in an investigational device trial within 30 days of enrollment
* Known drug or alcohol abuse 1 year prior to enrollment
* Has a history of psychological illness/condition that interferes with ability to understand or complete requirements of the study
* In the opinion of the investigator the subject is known to be noncompliant with prescribed medication regimen
18 Years
75 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Changsheng Ma, Professor
Role: PRINCIPAL_INVESTIGATOR
Beijing Anzhen Hospital
Locations
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Gansu Provincial Hospital
Lanzhou, Gansu, China
Tongji Hospital
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Taizhou Hospital
Taizhou, Zhejiang, China
Beijing ANZHEN Hospital
Beijing, , China
China-Japan Friendship Hospital
Beijing, , China
Xuan Wu Hospital affiliated to Capital Medical University
Beijing, , China
Beijing Tongren hospital affiliated to Capital Medical University
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Changsheng Ma, Professor
Role: primary
Other Identifiers
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KWDLHF2012
Identifier Type: -
Identifier Source: org_study_id