Study to Evaluate the Safety of Twice Daily Oral Carvedilol

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00129363
• Date of registration: 08/08/2005
• Prospective Registration: No
• Primary sponsor: Shaddy, Robert, M.D.
• Public title: Study to Evaluate the Safety of Twice Daily Oral Carvedilol
• Scientific title: A Multicenter, Open Label Extension Study to Evaluate the Safety of Twice Daily Oral Carvedilol in Pediatric Patients With Chronic Heart Failure
• Date of first enrolment: January 2002
• Target sample size: 75
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00129363
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Robert E Shaddy, MD
• Affiliation: University of Utah

Key inclusion & exclusion 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;

- a- 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.



Age minimum: N/A
Age maximum: 17 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Congestive Heart Failure

Intervention(s)

Drug: Carvedilol

Primary Outcome(s)

an echocardiographic measurement

physical exam (PE) including cardiopulmonary examination

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

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

pregnancy test, if applicable

growth and development

dose tolerability

laboratory safety assessments

Secondary ID(s)

SB 105517-396

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

GlaxoSmithKline