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Study to Evaluate the Safety of Twice Daily Oral Carvedilol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00129363
Recruitment Status : Completed
First Posted : August 11, 2005
Last Update Posted : December 25, 2008
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Shaddy, Robert, M.D.

Brief 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 Corporation d/b/a GlaxoSmithKline (GSK) or the University Sponsor.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Drug: Carvedilol Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open Label Extension Study to Evaluate the Safety of Twice Daily Oral Carvedilol in Pediatric Patients With Chronic Heart Failure
Study Start Date : January 2002
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Carvedilol




Primary Outcome Measures :
  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)


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
    • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00129363


Locations
Show Show 17 study locations
Sponsors and Collaborators
Shaddy, Robert, M.D.
GlaxoSmithKline
Investigators
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Principal Investigator: Robert E Shaddy, MD University of Utah

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Responsible Party: Robert E Shaddy, MD, The Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00129363    
Other Study ID Numbers: SB 105517-396
First Posted: August 11, 2005    Key Record Dates
Last Update Posted: December 25, 2008
Last Verified: December 2008
Keywords provided by Shaddy, Robert, M.D.:
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
Male
Natriuretic Peptide, Brain/blood
Placebos
Propanolamines/therapeutic use
Propanolamines/administration & dosage
Prospective Studies
Support, Non-U.S. Gov't
Treatment Outcome
Ventricular Dysfunction/drug therapy
Ventricular Dysfunction/complications
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Carvedilol
Adrenergic beta-Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Antioxidants
Protective Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists