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Congestive Heart FailurePhase 3NCT00129363

Study to Evaluate the Safety of Twice Daily Oral Carvedilol

A Phase 3 study testing Carvedilol in people with Congestive Heart Failure, run by Shaddy, Robert, M.D. at 17 sites in United States.

Completed

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

Official record
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Trial summary

The objective of this study is to evaluate the long-term safety of carvedilol in pediatric patients with chronic heart failure, who completed the Pediatric Carvedilol Study 321. Carvedilol will be provided as open-label therapy for a period of at least 6 months (or until termination of the study) by SmithKline Beecham… Read more about this study

Who is it for?
Ages 1 day to 17 years
Conditions the study is for
Congestive Heart Failure
What is being tested?
Carvedilol
How many people
75 participants
Where
17 sitesUnited States
Study dates
Jan 2002to Jan 2006
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 1 day to 17 years
  • All sexes
  • Child

Who may be able to join

  • Male or female patients with chronic symptomatic congestive heart failure (CHF) due to systemic ventricular systolic dysfunction, who are receiving standard heart failure therapy and have successfully completed the maintenance phase of the Pediatric Carvedilol Study 321.
  • Parent or guardian of patient able and willing to give written informed consent. The written assent from children > 9 years of age is also required.

Who cannot join

  • A patient who, in the opinion of the investigator, would not benefit from open-label carvedilol.
  • A patient who, in the opinion of the investigator, is incapable of cooperating with the requirements of this study.
  • A patient treated with the following medications at the time of entry in the study:
  • Monoamine oxidase (MAO) inhibitors;
  • Calcium entry blockers;
  • α- blockers, or labetalol;
Show all 24Show fewer
  • Disopyramide, flecainide, encainide, moricizine, propafenone;
  • Intravenous inotropes such as dobutamine or intravenous vasodilator agents such as amrinone or milrinone;
  • Intravenous CHF medications (e.g. diuretics, digoxin);
  • Beta-blockers, other than double-blind carvedilol.
  • Uncorrected primary obstructive or severe regurgitative valvular disease, nondilated (restrictive) or hypertrophic cardiomyopathy, or significant systemic ventricular outflow obstruction.
  • A patient with any of the following contra-indications to beta-blocker therapy:
  • Heart rate < 2nd percentile for age;
  • Unacceptable blood pressure. Sitting (supine in infants) systolic blood pressure must be > 85 mm Hg in teens; >75 mm Hg in school-aged children; and >65 mm Hg in infants;
  • Sick sinus syndrome, second or third degree atrioventricular (AV) block, unless treated with a permanent pacemaker;
  • History or current clinical evidence of moderate-to-severe obstructive pulmonary disease or reactive airway diseases (e.g., asthma) requiring therapy;
  • Unstable insulin-dependent diabetes mellitus.
  • Renovascular hypertension or evidence of pulmonary hypertension (pulmonary vascular resistance index > 6 Wood units m2) unresponsive to vasodilator agents such as oxygen, nitroprusside, or nitric oxide
  • A patient with any one of these general exclusion criteria:
  • Significant renal (serum creatinine > 2.0), hepatic (serum AST and/or ALT > 3 times upper limit of normal), gastrointestinal, or biliary disorders that could impair absorption, metabolism, or excretion of orally administered medications;
  • Endocrine disorders such as pheochromocytoma, active hyperthyroidism and untreated hypothyroidism;
  • Any illness other than heart failure that may limit survival within 1 year (e.g. neoplasm);
  • Girls of childbearing potential who are pregnant or sexually active and not taking adequate contraceptive precautions (e.g., intrauterine device [IUD] or oral contraceptives).
  • A patient who received any investigational drug within the preceding 30 days except blinded medication in Pediatric Carvedilol Study 321. An investigational drug is defined as any agent (placebo or drug) dispensed as part of a research study.

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • C.S. Mott Children's Hospital

    Ann Arbor, Michigan, 48109

  • Children's Hospital, Boston

    Boston, Massachusetts, 02115

  • Children's Memorial Hospital

    Chicago, Illinois, 60614

  • UT Southwestern Medical Center

    Dallas, Texas, 75235-7794

  • University of Colorado

    Denver, Colorado, 80218

  • Children's Hospital of Michigan

    Detroit, Michigan, 48201-2196

  • Texas Children's Hospital

    Houston, Texas, 77030

  • Mattel Children's Hospital at UCLA

    Los Angeles, California, 90025

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027

  • University of Miami

    Miami, Florida, 33101

  • Vanderbilt Children's Hospital

    Nashville, Tennessee, 37332

  • Columbia University

    New York, New York, 10032-1537

  • Stanford University

    Palo Alto, California, 94303

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • University of Utah

    Salt Lake City, Utah, 84132

  • Seattle Childrens Hospital and Regional Medical Center

    Seattle, Washington, 98105

  • Washington University

    St Louis, Missouri, 63110-1014

Other trials in United States

About this study

Official title: A Multicenter, Open Label Extension Study to Evaluate the Safety of Twice Daily Oral Carvedilol in Pediatric Patients With Chronic Heart Failure

The objective of this study is to evaluate the long-term safety of carvedilol in pediatric patients with chronic heart failure, who completed the Pediatric Carvedilol Study 321. Carvedilol will be provided as open-label therapy for a period of at least 6 months (or until termination of the study) by SmithKline Beecham Corporation d/b/a GlaxoSmithKline (GSK) or the University Sponsor.

Read the detailed description

This open-label, uncontrolled, extension study is designed to assess the long-term safety of carvedilol in pediatric patients with heart failure and includes the following phases:

  1. Screening Phase (coincides with the final maintenance Month 6 Visit in the 321 study
  2. Down-/Up-titration Phase
  3. Maintenance Phase
  4. Down-titration
  5. Follow-up
Being tested
Carvedilol
Keywords
Adolescent, Adrenergic alpha-Antagonists/therapeutic use, Adrenergic alpha-Antagonists/pharmacokinetics, Adrenergic alpha-Antagonists/administration & dosage, Adrenergic beta-Antagonists/therapeutic use, Adrenergic beta-Antagonists/pharmacokinetics, Adrenergic beta-Antagonists/administration & dosage, Age Factors, Carbazoles/therapeutic use, Carbazoles/administration & dosage, Child, Child, Preschool, Drug Administration Schedule, Female, Heart Failure, Congestive/etiology, Heart Failure, Congestive/drug therapy, Heart Failure, Congestive/blood, Human, Infant, Infant, Newborn
Medical subject headings
Heart Failure, Ventricular Dysfunction

What participants receive

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

  • CarvedilolDrug

What is being measured

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

  1. dose tolerability

  2. growth and development

  3. physical exam (PE) including cardiopulmonary examination

  4. blood pressure (BP), heart rate (HR), height (Ht) and weight [Wt] (including %)

  5. laboratory safety assessments

  6. pregnancy test, if applicable

  7. an echocardiographic measurement

  8. reporting of all adverse events [AEs] (serious and non-serious)

Timeline

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

  1. First posted11 Aug 2005 (estimated)
  2. Study startJan 2002
  3. Primary completionJan 2006
  4. Study completionJan 2006

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00129363
Sponsor's protocol ID
SB 105517-396
Status last verified
Dec 2008
First submitted
8 Aug 2005
Last updated
25 Dec 2008
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Carvedilol in people with Congestive Heart Failure, run by Shaddy, Robert, M.D. at 17 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 2 inclusion and 24 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 25 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

dose tolerability. The study lists 8 primary outcomes in all. 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 NCT00129363.

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 25 Dec 2008.

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