Study to Characterize the Long-Term Clinical Experience of Atacand in Hypertensive Children Ages 1 to<11 Years

Condition(s) targeted: Hypertension

Intervention: candesartan cilexetil (Drug)

Phase: Phase 3

Status: Enrolling by invitation

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Franz Schaefer, MD, Principal Investigator, Affiliation: University Children's Hospital, Heidelberg, Germany D69120

The HIP study is designed to follow the clinical experience of young hypertensive children receiving candesartan cilexetil (Atacand) who are between the ages of 1 and less than 11 years old. The study is open label with no concurrent control group. To be eligible for HIP, children must have completed Study 328 without discontinuation due to a study drug-related AE and in the investigator's opinion, have an on-going clinical indication for an orally administered suspension of candesartan cilexetil to control blood pressure. Children will return to clinic every 3 months (more frequently at the investigator's discretion) for safety and efficacy evaluations. Safety will be monitored by serum chemistries, urinalyses, echocardiograms and by physical examinations at specified clinic visits. Blood pressure and heart rate will be measured at each clinic visit. Study drug is administered orally once a day. Investigators determine the efficacious dose ( 0. 05 mg/kg; 0. 2 mg/kg; 0. 4 mg/kg) on a vist-by-vist basis depending on the child's BP response. It is anticipated that study dose will align closely with the effective anti-hypertensive dose determined in Study 328. If the child's hypertension is not well-controlled, dose adjustments up to a maximum of 0. 4mg/kg/day and/or the addition of other antihypertensive medications are permitted, with the exception of other angiotensin receptor blockers. The HIP study offers eligible children up to two additional years of treatment with the liquid formulation of Atacand.

Official title: An Open-Label Extension Study of Candesartan Cilexetil in Hypertensive Pediatric Subjects Ages 1 to <11 Years: a Long Term Study

Study design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study

Primary outcome:

systolic blood pressure (SBP) and diastolic blood pressure (DBP) measurements

Adverse events, including abnormal physical exam findings,laboratory test abnormalities, adverse events that necessitate drug discontinuation, and serious adverse events.

Minimum age: 1 Year. Maximum age: 10 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Must have participated in Protocol 328 (without discontinuation due to a study drug

related AE).

- Must sign an informed consent prior to initiating any stus dy procedures.

- Have, in the opinion of the investigator, an on-going clinical indication for oral

liquid formulation of candesartan cilexetil to control hypertension

- Weight ≥ 10 kg and ≤ 40 kg.

Exclusion Criteria:

- Any situation, clinical condition (such as clinically significant declining renal

function) or laboratory abnormality that, in the opinion of the investigator or sponsor, may interfere with the subject's participation in the study.

- Estimated glomerular filtration rate (GFR) <30 ml/min/1. 73m2 for non-transplant

patients and <40 ml/min/1. 73m2 for transplant patients based on the Schwartz Formula (Schwartz et al 1987) as determined at enrollment into Study 328.

- Impaired liver function defined as either acute liver disease or chronic liver disease

with persistently elevated liver enzyme values judged clinically significant by the investigator.

- Currently using any medications that, in the opinion of the investigator could

negatively affect the subject when given together with candesartan cilexetil.

Research Site, EDEGEM, Belgium

Research Site, GENT, Belgium

Research Site, STRASBOURG CEDEX, France

Research Site, ERLANGEN, Germany

Research Site, HEIDELBERG, Germany

Research Site, MARBURG, Germany

Research Site, ROSTOCK, Germany

Research Site, GENOVA, Italy

Research Site, PADOVA, Italy

Research Site, GDASK, Poland

Research Site, KRAKOW, Poland

Starting date: September 2007
Ending date: November 2009
Last updated: June 2, 2008