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Congestive Heart FailurePhase 3COMPARENCT00323037

A Study to Compare the Effects of Coreg CR and Coreg IR on Heart Function in Subjects With Stable Chronic Heart Failure

A Phase 3 study testing carvedilol immediate release in people with Congestive Heart Failure, run by CTI-1, LLC at 75 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to determine if Coreg CR is as effective as Coreg IR in improving heart function in subjects with stable chronic heart failure. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Congestive Heart Failure
What is being tested?
carvedilol immediate release
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
318 participants
Where
75 sitesUnited States
Study dates
Mar 2006to Jun 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or non-pregnant female
  • At least 18 years of age at the time informed consent is signed
  • Stable, chronic, mild to severe heart failure as defined as subjects with symptoms of heart failure who do not require IV diuretics, inotropes, or vasodilators or those that require support with a left ventricular assist device
  • Angiotensin converting enzyme inhibitors or angiotensin receptor blockers should be prescribed to all patients with HF due to LV systolic dysfunction with reduced LVEF unless contraindicated or intolerant to use
  • At screening, subject has an LVEF < 40 as measured by 2-D echocardiography
  • Willing to provide written informed consent

Who cannot join

  • On beta-blocker therapy for greater than 42 days prior to consent
  • Acute ischemic coronary event or coronary revascularization (PTCA, CABG, thrombolysis) within 1 week of screening echocardiography
  • Scheduled or expected to be scheduled coronary revascularization within 4 weeks
  • Unstable angina (angina characterized by sudden changes in the severity or length of angina attacks or a decrease in level of exertion that precipitates an episode
  • Uncorrected primary obstructive or severe regurgitant valvular disease, nondilated (restrictive) or hypertrophic cardiomyopathies
  • Uncontrolled ventricular arrhythmias (symptomatic or sustained ventricular arrhythmias not controlled with antiarrhythmic therapy or an implantable defibrillator)
Show all 25Show fewer
  • Current treatment of calcium channel blockers except for long acting dihydropyridines
  • Current treatment on any Class I or III antiarrhythmic, except amiodarone
  • History of sick sinus syndrome unless a pacemaker is in place
  • Second or third degree heart block unless a pacemaker is in place
  • Current clinical evidence of obstructive pulmonary disease (e.g., asthma or bronchitis) requiring inhaled or oral bronchodilator or steroid therapy; or having a history of bronchospastic disease not undergoing active therapy in whom, in the investigator's opinion, treatment with study medication could provoke bronchospasm
  • Expected biventricular pacemaker placement within 8 months of enrollment
  • Resting systolic blood pressure <90 mmHg (based on the average of 3 readings
  • Resting heart rate <50 beats per minute (bpm) (based on the average of 3 readings)
  • Current decompensated heart failure
  • Elevated liver enzymes (i.e., ALT or AST levels greater than 3 times upper limit of normal)
  • 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. NOTE: Female subjects must be post-menopausal (i.e., no menstrual period for a minimum of 6 months prior to screening), surgically sterilized, using a double barrier method contraceptive, or using Depo-Provera or implanted contraceptives for at least one month prior to screening and agree to continue to use the same contraceptive method throughout the study.
  • 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
  • In the opinion of the investigator the subject is known to be noncompliant with prescribed medication regimen
  • Has any systemic disease, including cancer, with reduced life expectancy (<12 months)
  • Has a history of psychological illness/condition that interferes with ability to understand or complete requirements of the study.

Trial locations and contacts

75 sites in 1 country.

75 sites in 1 country

United States75 sites

  • Albany Associates in Cardiology

    Albany, New York, 12205

  • University of New Mexico

    Albuquerque, New Mexico, 87131-0001

  • Blair Medical Associates

    Altoona, Pennsylvania, 16602

  • Cardiac Disease Specialists, PC

    Atlanta, Georgia, 30309

  • One Heart, LLC

    Baltimore, Maryland, 21215

  • North Shore Cardiovascular Research Consortium

    Bannockburn, Illinois, 60015

  • Tri-State Medical Group

    Beaver, Pennsylvania, 15009

  • Bay Area Cardiology

    Brandon, Florida, 33511

  • Buffalo Heart Group, LLP

    Buffalo, New York, 14215

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Charleston Cardiology

    Charleston, South Carolina, 29403

  • Sterling Research Group Ltd.

    Cincinnati, Ohio, 45219

  • The Lindner Clinical Trial Center

    Cincinnati, Ohio, 45219

  • University Hospital

    Cincinnati, Ohio, 45267-0542

  • Clearwater Cardiovascular and Interventional Consultants

    Clearwater, Florida, 33756

  • South Carolina Heart Center

    Columbia, South Carolina, 29204

  • Inland Heart Doctors Medical Group

    Corona, California, 92879

  • Samaritan Cardiology

    Corvallis, Oregon, 97330

  • Aurora Denver Cardiology Associates

    Denver, Colorado, 80218

  • Rancho Los Amigos USC

    Downey, California, 90242

  • Central Bucks Specialists

    Doylestown, Pennsylvania, 18901

  • Luther Midelfort Mayo Health Systems

    Eau Claire, Wisconsin, 54702

  • Minnesota Heart Clinic

    Edina, Minnesota, 55435

  • Saint Francis Hospital

    Evanston, Illinois, 60202

  • Comprehensive Cardiology Associates

    Florence, Kentucky, 41042

  • White-Wilson Medical Center, PA

    Fort Walton Beach, Florida, 32547

  • Heart Specialists

    Friendswood, Texas, 77546

  • Green Bay HeartCare

    Green Bay, Wisconsin, 54303

  • LeBauer Cardiovascular Research Foundation

    Greensboro, North Carolina, 27401

  • William Bowden, DO Private Practice

    Healdsburg, California, 95448

  • Illinois Heart and Vascular

    Hinsdale, Illinois, 60521

  • The Care Group LLC

    Indianapolis, Indiana, 46260

  • River Cities Cardiology

    Jeffersonville, Indiana, 47130

  • Rocky Mountain Heart & Lung

    Kalispell, Montana, 59901

  • Mid-America Cardiology

    Kansas City, Kansas, 66160

  • Cardiovascular Associates

    Louisville, Kentucky, 40205

  • Louisville Cardiology Medical Group

    Louisville, Kentucky, 40207

  • Medical Center of the Rockies Foundation

    Loveland, Colorado, 80538

  • Texas Cardiac Center

    Lubbock, Texas, 79410

  • Merced Heart Associates

    Merced, California, 95340

  • South Florida International Cardiology Consultants, Inc.

    Miami, Florida, 33137-3732

  • Long Island Heart Associates

    Mineola, New York, 11501

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Cardiology Associates

    Mobile, Alabama, 36608

  • Mobile Heart Specialists

    Mobile, Alabama, 36608

  • Intermountain Medical Center

    Murray, Utah, 84107

  • New York Cardiovascular Associates

    New York, New York, 10035

  • Oklahoma Cardiovascular Research Group

    Oklahoma City, Oklahoma, 73120

  • Palm Beach Cardiology

    Palm Beach Gardens, Florida, 33410

  • HeartCare Midwest

    Peoria, Illinois, 61614

  • Cardiology Consultants of Philadelphia

    Philadelphia, Pennsylvania, 19148

  • Mid State Medical Service

    Philipsburg, Pennsylvania, 16866

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054

  • Rhode Island Heart Failure Center

    Providence, Rhode Island, 02903

  • Rockford Cardiology Research Foundation

    Rockford, Illinois, 61107

  • Harbin Clinic

    Rome, Georgia, 30165

  • Sutter Memorial Hospital

    Sacramento, California, 95819

  • Regions Hospital Cardiology Research

    Saint Paul, Minnesota, 55101

  • St. Paul Cardiology

    Saint Paul, Minnesota, 55102

  • Heart Center

    Salt Lake City, Utah, 84124

  • Southern California Cardiology Medical Group, Inc.

    San Diego, California, 92120

  • Scottsdale Cardiovascular Research Institute

    Scottsdale, Arizona, 85251

  • Buxmont Cardiology Associates, PC

    Sellersville, Pennsylvania, 18960

  • Prairie Cardiovascular Consultants

    Springfield, Illinois, 62701

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Northwest Ohio Cardiology Consultants

    Toledo, Ohio, 43615

  • South West Heart

    Tucson, Arizona, 85715

  • Cardiology Associates Research, LLC

    Tupelo, Mississippi, 38801

  • Medvin Clinical Research

    Van Nuys, California, 91405

  • Iowa Heart Center

    West Des Moines, Iowa, 50266

  • South Bay Cardiovascular Associates

    West Islip, New York, 11795

  • Diagnostic and Clinical Cardiology

    West Orange, New Jersey, 07052

  • Via Christi Research, Inc.

    Wichita, Kansas, 67214

  • Winchester Medical Center

    Winchester, Virginia, 22601

  • Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: A Multicenter,Randomized, Double Blind, Double Dummy, Parallel Group Study to Compare Effects of Coreg CR and Coreg IR on Left Ventricular End Systolic Volume Index in Subjects With Stable Chronic Heart Failure

The purpose of this study is to determine if Coreg CR is as effective as Coreg IR in improving heart function in subjects with stable chronic heart failure.

Read the detailed description

Results of clinical trials have shown beta-blockers improve symptoms and left ventricular function, reduce hospitalizations and death in heart failure, and prolong survival [MERIT-HF, CIBIS-II, Packer, 1996]. Clinical guidelines mandate use of beta-blockers in treatment of subjects with heart failure.

Carvedilol (Coreg IR) is a multiple action adrenergic receptor blocker with alpha 1, beta 1 and beta 2 receptor blockade properties. The beta-adrenergic properties are non-selective for beta 1 and beta 2 adrenergic receptors. Coreg IR, administered twice daily, is marketed in the United States for long term treatment of mild-moderate hypertension, mild to severe heart failure and subjects surviving an acute myocardial infarction with left ventricular dysfunction with or without symptomatic heart failure.

Coreg IR significantly reduces all cause mortality and the need for cardiovascular hospitalization [Packer, 1996a; Packer, 1996b; Colucci, 1996; Cohn, 1997; Olsen, 1995; Sharpe 1997]. The effect of Coreg is dose dependent [Bristow, 1996]. In subjects treated long term after an acute myocardial infarction (MI) complicated by left ventricular systolic dysfunction, Coreg IR reduced the frequency of all-cause and cardiovascular mortality, and recurrent non-fatal MIs. These beneficial effects are additional to those of evidence-based treatments for acute MI, including ACE inhibitors [Dargie, 2001].

Left Ventricular End Systolic Volume Index (LVESVI) is an important measure of ventricular function and remodeling in the evaluation of heart failure. In controlled clinical trials, Coreg IR, administered twice daily, has reduced LVESVI in subjects with ischemic heart failure. An echocardiography substudy of the Australia-New Zealand Trial [Doughty, 1997], evaluated left ventricular remodeling in 123 subjects with ischemic heart failure with an LVEF < 45 randomized to carvedilol or placebo. The LVESVI was reduced by 6.2 + 1.6 ml/m2 after 6 months and 8.7 + 2.6 ml/m2 after 12 months of carvedilol therapy compared to the placebo treated subjects. Metra et al [Metra, 2000] observed the favorable effects of carvedilol compared with metoprolol on LVEF, LV stroke volume, and pulmonary artery pressure despite similar effects on cardiovascular outcome. Both groups also showed significant decreases in LV systolic volume. Doughty et al [Doughty, 2004] observed the favorable effects of carvedilol on LV remodeling, with improved LV end-systolic volume and ejection fraction, after 6 months of treatment.

Carvedilol phosphate CR (Coreg CR) is an approved, modified release, once-daily formulation of carvedilol that is hoped to provide an advance in patient care through improved compliance with prescribed dose.

The clinical experience with various formulations of Coreg CR is limited to eight single dose studies in healthy subjects and one repeated dose study in subjects with hypertension. In total 230, adult subjects have received at least one dose of Coreg IR or one of several CR formulations across nine studies. The subjects ranged in age from 18 to 63 years; 62% were male and 69% were white. The various formulations of Coreg CR capsules were safe and well tolerated in single dose pharmacokinetic studies in doses ranging from 6.25 to 60 mg in healthy subjects. The most common adverse events were headache, dizziness and orthostatic hypotension and are all known adverse events following administration of Coreg IR [GSK Study 386, 388, 399, 400, 402, 907].

This study will be the first controlled clinical study investigating the efficacy of treatment with Coreg CR formulation [Coreg CR filled with 7.5 mg of carvedilol phosphate immediate release (IRp) microparticles, 22.5 mg of carvedilol phosphate Micropump IIa MR microparticles, and 30 mg of carvedilol phosphate Micropump IIc MR microparticles] compared to Coreg IR evaluating LVESVI in subjects with stable chronic heart failure.

Being tested
carvedilol controlled release, carvedilol immediate release
Keywords
heart failure
Medical subject headings
Heart Failure

What participants receive

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

  • carvedilol controlled releaseDrug

    Also called Coreg CR

    Carvedilol controlled release (10, 20, 40 or 80 mg) and placebo taken in the morning. Two placebos taken in the evening. A total of 4 pills will be taken PO daily.

  • carvedilol immediate releaseDrug

    Also called Coreg, Coreg IR

    Carvedilol immediate release (3.125, 6.25, 12.5 or 25 mg) and placebo, taken PO, twice-daily.

Study groups in NCT00323037
Study groupRoleWhat they receive
1Active comparatorNot described
Receives: Drug: carvedilol immediate release
2Active comparatorNot described
Receives: Drug: carvedilol controlled release

What is being measured

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

  1. Change From Baseline in Left Ventricular End Systolic Volume Index (LVESVI) Characterized by 2-D Echocardiography

    Maintenance Visit 3 minus Baseline. Maintenance Visit 3 occurred 24 weeks after entry into the maintenance period. The maintenance period started after completion of a titration period of variable duration.

    Measured: 24 weeks after entry into the maintenance period

Secondary outcomes (16)

  1. Change From Baseline in Left Ventricular Ejection Fraction (LVEF)

    Measured: 24 weeks after entry into the maintenance period

  2. Change From Baseline in Left Ventricular End Diastolic Volume (LVEDV)

    Measured: 24 weeks after entry into the maintenance period

  3. Change From Baseline in Left Ventricular End Systolic Volume (LVESV)

    Measured: 24 weeks after entry into the maintenance period

  4. Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVI)

    Measured: 24 weeks after entry into the maintenance period

  5. Change From Baseline in Intraventricular Septal Thickness (IVST)

    Measured: 24 weeks after entry into the maintenance period

  6. Change From Baseline in Posterior Wall Thickness (PWT)

    Measured: 24 weeks after entry into the maintenance period

  7. Change From Baseline in Left Ventricular Mass (LVM)

    Measured: 24 weeks after entry into the maintenance period

  8. Change From Baseline in End Diastolic Dimension (EDD)

    Measured: 24 weeks after entry into the maintenance period

  9. Change From Baseline in End Systolic Dimension (ESD)

    Measured: 24 weeks after entry into the maintenance period

  10. Change From Baseline in Deceleration Time

    Measured: 24 weeks after entry into the maintenance period

  11. Change From Baseline in Early to Late Atrial Ratio (E:A Ratio)

    Measured: 24 weeks after entry into the maintenance period

  12. Change From Baseline in BNP Levels

    Measured: 24 weeks after entry into the maintenance period

  13. Incidence of Hospitalizations

    Measured: Up to 32 weeks (titration and maintenance phases)

  14. Drug Dose Tolerability

    Measured: Up to 32 weeks (titration and maintenance phases)

  15. Treatment Compliance

    Measured: Up to 32 weeks (titration and maintenance phases)

  16. Safety and Tolerability of Coreg CR

    SAEs experienced

    Measured: 24 weeks after entry into the maintenance phase (after unblinding)

Timeline

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

  1. First posted9 May 2006 (estimated)
  2. Study startMar 2006
  3. Primary completionApr 2008
  4. Study completionJun 2008

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
318 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00323037
Sponsor's protocol ID
104852
Acronym
COMPARE
Status last verified
Mar 2023
First submitted
5 May 2006
Last updated
28 Mar 2023
Data monitoring committee
No

Publications

  • Effect of metoprolol CR/XL in chronic heart failure: Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure (MERIT-HF). Lancet. 1999 Jun 12;353(9169):2001-7.

    PubMed 10376614

  • The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): a randomised trial. Lancet. 1999 Jan 2;353(9146):9-13.

    PubMed 10023943

  • Packer M, Colucci WS, Sackner-Bernstein JD, Liang CS, Goldscher DA, Freeman I, Kukin ML, Kinhal V, Udelson JE, Klapholz M, Gottlieb SS, Pearle D, Cody RJ, Gregory JJ, Kantrowitz NE, LeJemtel TH, Young ST, Lukas MA, Shusterman NH. Double-blind, placebo-controlled study of the effects of carvedilol in patients with moderate to severe heart failure. The PRECISE Trial. Prospective Randomized Evaluation of Carvedilol on Symptoms and Exercise. Circulation. 1996 Dec 1;94(11):2793-9. doi: 10.1161/01.cir.94.11.2793.

    PubMed 8941104

  • Packer M, Bristow MR, Cohn JN, Colucci WS, Fowler MB, Gilbert EM, Shusterman NH. The effect of carvedilol on morbidity and mortality in patients with chronic heart failure. U.S. Carvedilol Heart Failure Study Group. N Engl J Med. 1996 May 23;334(21):1349-55. doi: 10.1056/NEJM199605233342101.

    PubMed 8614419

  • Colucci WS, Packer M, Bristow MR, Gilbert EM, Cohn JN, Fowler MB, Krueger SK, Hershberger R, Uretsky BF, Bowers JA, Sackner-Bernstein JD, Young ST, Holcslaw TL, Lukas MA. Carvedilol inhibits clinical progression in patients with mild symptoms of heart failure. US Carvedilol Heart Failure Study Group. Circulation. 1996 Dec 1;94(11):2800-6. doi: 10.1161/01.cir.94.11.2800.

    PubMed 8941105

  • Cohn JN, Fowler MB, Bristow MR, Colucci WS, Gilbert EM, Kinhal V, Krueger SK, Lejemtel T, Narahara KA, Packer M, Young ST, Holcslaw TL, Lukas MA. Safety and efficacy of carvedilol in severe heart failure. The U.S. Carvedilol Heart Failure Study Group. J Card Fail. 1997 Sep;3(3):173-9. doi: 10.1016/s1071-9164(97)90013-0.

    PubMed 9330125

  • Olsen SL, Gilbert EM, Renlund DG, Taylor DO, Yanowitz FD, Bristow MR. Carvedilol improves left ventricular function and symptoms in chronic heart failure: a double-blind randomized study. J Am Coll Cardiol. 1995 May;25(6):1225-31. doi: 10.1016/0735-1097(95)00012-S.

    PubMed 7722114

  • Randomised, placebo-controlled trial of carvedilol in patients with congestive heart failure due to ischaemic heart disease. Australia/New Zealand Heart Failure Research Collaborative Group. Lancet. 1997 Feb 8;349(9049):375-80.

    PubMed 9033462

  • Bristow MR, Gilbert EM, Abraham WT, Adams KF, Fowler MB, Hershberger RE, Kubo SH, Narahara KA, Ingersoll H, Krueger S, Young S, Shusterman N. Carvedilol produces dose-related improvements in left ventricular function and survival in subjects with chronic heart failure. MOCHA Investigators. Circulation. 1996 Dec 1;94(11):2807-16. doi: 10.1161/01.cir.94.11.2807.

    PubMed 8941106

  • Dargie HJ. Effect of carvedilol on outcome after myocardial infarction in patients with left-ventricular dysfunction: the CAPRICORN randomised trial. Lancet. 2001 May 5;357(9266):1385-90. doi: 10.1016/s0140-6736(00)04560-8.

    PubMed 11356434

  • Doughty RN, Whalley GA, Walsh HA, Gamble GD, Lopez-Sendon J, Sharpe N; CAPRICORN Echo Substudy Investigators. Effects of carvedilol on left ventricular remodeling after acute myocardial infarction: the CAPRICORN Echo Substudy. Circulation. 2004 Jan 20;109(2):201-6. doi: 10.1161/01.CIR.0000108928.25690.94. Epub 2004 Jan 5.

    PubMed 14707020

  • Doughty RN, Whalley GA, Gamble G, MacMahon S, Sharpe N. Left ventricular remodeling with carvedilol in patients with congestive heart failure due to ischemic heart disease. Australia-New Zealand Heart Failure Research Collaborative Group. J Am Coll Cardiol. 1997 Apr;29(5):1060-6. doi: 10.1016/s0735-1097(97)00012-0.

    PubMed 9120160

  • Greenberg BH, Mehra M, Teerlink JR, Ordronneau P, McCollum D, Gilbert EM. COMPARE: comparison of the effects of carvedilol CR and carvedilol IR on left ventricular ejection fraction in patients with heart failure. Am J Cardiol. 2006 Oct 2;98(7A):53L-59L. doi: 10.1016/j.amjcard.2006.08.003. Epub 2006 Aug 28.

    PubMed 17023233

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing carvedilol immediate release in people with Congestive Heart Failure, run by CTI-1, LLC at 75 sites in United States.

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 6 inclusion and 25 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: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 75 sites in United States. 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?

Yes. Results are posted in the registry (first posted 13 Mar 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Left Ventricular End Systolic Volume Index (LVESVI) Characterized by 2-D Echocardiography (time frame: 24 weeks after entry into the maintenance period). 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 NCT00323037, which also lists 13 linked publications.

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 28 Mar 2023.

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