Study to Evaluate the Safety of Twice Daily Oral Carvedilol
NCT ID: NCT00129363
Last Updated: 2008-12-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
75 participants
INTERVENTIONAL
2002-01-31
2006-01-31
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Carvedilol
Eligibility Criteria
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Inclusion Criteria
* 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, 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
* 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.
1 Day
17 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Shaddy, Robert, M.D.
INDIV
Responsible Party
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The Children's Hospital of Philadelphia
Principal Investigators
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Robert E Shaddy, MD
Role: PRINCIPAL_INVESTIGATOR
University of Utah
Locations
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Mattel Children's Hospital at UCLA
Los Angeles, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Stanford University
Palo Alto, California, United States
University of Colorado
Denver, Colorado, United States
University of Miami
Miami, Florida, United States
Children's Memorial Hospital
Chicago, Illinois, United States
Children's Hospital, Boston
Boston, Massachusetts, United States
C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
Washington University
St Louis, Missouri, United States
Columbia University
New York, New York, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Vanderbilt Children's Hospital
Nashville, Tennessee, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Seattle Childrens Hospital and Regional Medical Center
Seattle, Washington, United States
Countries
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Other Identifiers
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SB 105517-396
Identifier Type: -
Identifier Source: org_study_id