A Phase Ⅲ Study of Extended-Release Carvedilol Sulfate for the Treatment of Heart Failure

December 10, 2013 updated by: Jiangsu HengRui Medicine Co., Ltd.

Efficacy and Safety Comparison of Extended-Release Carvedilol Sulfate and Sustained-release Metoprolol Succinate in Patients With Heart Failure

The aim of present study is to evaluate the efficacy and safety of Extended-Release Carvedilol Sulfate versus Sustained-release Metoprolol Succinate in Patients With Mild or Moderate Chronic Heart Failure.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
316

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100029
        • Recruiting
        • Beijing Anzhen Hospital
      • Beijing, China, 100029
        • Recruiting
        • China-Japan Friendship Hospital
      • Beijing, China, 100053
        • Recruiting
        • Xuan Wu hospital affiliated to Capital Medical University
      • Beijing, China
        • Recruiting
        • Beijing Tongren Hospital Affiliated to Capital Medical University
    • Gansu
      • Lanzhou, Gansu, China
        • Recruiting
        • Gansu Provincial Hospital
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital
    • Hunan
      • Changsha, Hunan, China
        • Recruiting
        • The second Xiangya Hospital of Central South University
      • Changsha, Hunan, China
        • Recruiting
        • The Third Xiangya Hospital of Central South University
    • Jiangsu
      • Yangzhou, Jiangsu, China, 225001
        • Recruiting
        • Northern Jiangsu People's Hospital
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Recruiting
        • Shengjing Hospital of China Medical University
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • The First Affiliated Hospital of College of Medicine, Zhejiang University
      • Taizhou, Zhejiang, China
        • Recruiting
        • Taizhou Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males or Females
  • 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 any Class I or III antiarrhythmic, except amiodarone or beta-blockers
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Extended-Release Carvedilol Sulfate
18-72mg/d,po
Drug: Extended-Release Carvedilol Sulfate
ACTIVE_COMPARATOR: Sustained-release Metoprolol Succinate
11.875-190mg/d,po
Drug: Sustained-release Metoprolol Succinate

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change From Baseline in left ventricular ejection fraction(LVEF) by ultrasound cardiogram
Time Frame: Baseline and Week 36
Baseline and Week 36

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change From Baseline in Left Ventricular End Systolic Volume Index
Time Frame: Baseline and Week 36
Baseline and Week 36
Change From Baseline in Left Ventricular End Diastolic Volume Index
Time Frame: Baseline and Week 36
Baseline and Week 36
Incidence of Hospitalizations From Exacerbation of Heart Failure
Time Frame: Baseline and Week 36
Baseline and Week 36
Incidence of Hospitalizations From All Causes
Time Frame: Baseline and Week 36
Baseline and Week 36
Incidence of Deaths From All Causes
Time Frame: Baseline and Week 36
Baseline and Week 36
Change From Baseline in New York Heart Association（NYHA）classification
Time Frame: Baseline and Week 36
Baseline and Week 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2013

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 16, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KWDLHF2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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