AzTrials
AzTrials

Heart FailurePhase 3NCT02012075

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

A Phase 3 study testing Extended-Release Carvedilol Sulfate and Sustained-release Metoprolol Succinate in people with Heart Failure, run by Jiangsu HengRui Medicine Co., Ltd. at 12 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Heart Failure
What is being tested?
Extended-Release Carvedilol Sulfate and Sustained-release Metoprolol Succinate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
316 participants
Where
12 sitesChina
Study dates
Dec 2013to Feb 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 27Show fewer
  • 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

Trial locations and contacts

12 sites in 1 country.

Changsheng Ma, Professor contact

86-010-64456078

chshma@vip.sina.com

12 sites in 1 country

China12 sites, 12 recruiting

  • Beijing ANZHEN Hospital

    Beijing, 100029

    Changsheng Ma, Professor, 86-010-64456078, chshma@vip.sina.com

    Changsheng Ma, Professor

    Recruiting

  • China-Japan Friendship Hospital

    Beijing, 100029

    Recruiting

  • Xuan Wu Hospital affiliated to Capital Medical University

    Beijing, 100053

    Recruiting

  • Beijing Tongren hospital affiliated to Capital Medical University

    Beijing

    Recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan

    Recruiting

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan

    Recruiting

  • The First Affiliated Hospital of College of Medicine, Zhejiang University

    Hangzhou, Zhejiang

    Recruiting

  • Gansu Provincial Hospital

    Lanzhou, Gansu

    Recruiting

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004

    Recruiting

  • Taizhou Hospital

    Taizhou, Zhejiang

    Recruiting

  • Tongji Hospital

    Wuhan, Hubei, 430030

    Recruiting

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu, 225001

    Recruiting

Other trials in China

About this study

Official title: 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.

Conditions
Heart Failure
Being tested
Extended-Release Carvedilol Sulfate, Sustained-release Metoprolol Succinate
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Extended-Release Carvedilol SulfateDrug

  • Sustained-release Metoprolol SuccinateDrug

Study groups in NCT02012075
Study groupRoleWhat they receive
Extended-Release Carvedilol SulfateExperimental18-72mg/d,po
Receives: Drug: Extended-Release Carvedilol Sulfate
Sustained-release Metoprolol SuccinateActive comparator11.875-190mg/d,po
Receives: Drug: Sustained-release Metoprolol Succinate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in left ventricular ejection fraction(LVEF) by ultrasound cardiogram

    Measured: Baseline and Week 36

Secondary outcomes (6)

  1. Change From Baseline in Left Ventricular End Systolic Volume Index

    Measured: Baseline and Week 36

  2. Change From Baseline in Left Ventricular End Diastolic Volume Index

    Measured: Baseline and Week 36

  3. Incidence of Hospitalizations From Exacerbation of Heart Failure

    Measured: Baseline and Week 36

  4. Incidence of Hospitalizations From All Causes

    Measured: Baseline and Week 36

  5. Incidence of Deaths From All Causes

    Measured: Baseline and Week 36

  6. Change From Baseline in New York Heart Association（NYHA）classification

    Measured: Baseline and Week 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2013 (estimated)
  2. Study startDec 2013
  3. Primary completionFeb 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
316 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02012075
Sponsor's protocol ID
KWDLHF2012
Status last verified
Dec 2013
First submitted
10 Dec 2013
Last updated
16 Dec 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Extended-Release Carvedilol Sulfate and Sustained-release Metoprolol Succinate in people with Heart Failure, run by Jiangsu HengRui Medicine Co., Ltd. at 12 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Changsheng Ma, Professor (86-010-64456078, chshma@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in left ventricular ejection fraction(LVEF) by ultrasound cardiogram (time frame: Baseline and Week 36). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02012075.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in