Clinical trial NCT00690612: Study to Characterize the Long-term Clinical Experience of Atacand in Hypertensive Children Ages 1 to<11 Years (Hypertension in Pediatrics)
Official title: An Open-label Extension Study of Candesartan Cilexetil in Hypertensive Pediatric Subjects Ages 1 to <11 Years: a Long Term Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: pediatric
renal disease
high blood pressure
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-04
Enrollment: 35
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Mean Change From Baseline to Final Visit in Systolic Blood Pressure (SBP).
timeFrame: Every 3 months- baseline to final visit
measure: Mean Change From Baseline to Final Visit in Diastolic Blood Pressure (DBP).
timeFrame: every 3 months - baseline to final visit
Secondary outcomes:
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Research Site
city: Gent
country: Belgium
facility: Research Site
city: Strasbourg Cedex
country: France
facility: Research Site
city: Erlangen
country: Germany
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
city: Marburg
country: Germany
facility: Research Site
city: Rostock
country: Germany
facility: Research Site
city: Genova
country: Italy
facility: Research Site
state: GE
city: Padova
country: Italy
facility: Research Site
state: PD
city: Gda�sk
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Crimea
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
Study officials:
affiliation: University Children's Hospital, Heidelberg, Germany D69120
name: Franz Schaefer, MD
role: PRINCIPAL_INVESTIGATOR
References: