Study to Characterize the Long-term Clinical Experience of Atacand in Hypertensive Children Ages 1 to<11 Years (Hypertension in Pediatrics) (HIP)

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: candesartan cilexetil

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Edegem, Belgium
    • Research Site
  • Gent, Belgium
    • Research Site
• France
  • Strasbourg Cedex, France
    • Research Site
• Germany
  • Erlangen, Germany
    • Research Site
  • Heidelberg, Germany
    • Research Site
  • Marburg, Germany
    • Research Site
  • Rostock, Germany
    • Research Site
• Italy
  • GE
    • Genova, GE, Italy
      • Research Site
  • PD
    • Padova, PD, Italy
      • Research Site
• Poland
  • Gda�sk, Poland
    • Research Site
  • Krakow, Poland
    • Research Site
• Ukraine
  • Crimea, Ukraine
    • Research Site
  • Kyiv, Ukraine
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 10 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1; investigator determines efficacious dose based on child's BP response.	Drug: candesartan cilexetil; 0.05, 0.2, 0.4 mg/kg, oral solution, single daily dose; Other Names: Atacand

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline to Final Visit in Systolic Blood Pressure (SBP).	Blood pressure response was defined as Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) less than the 95th percentile based on population height-adjusted charts for age and gender. Response rates were based on the proportion of patients meeting the criteria at each evaluation time point or the last available measure.	Every 3 months- baseline to final visit
Mean Change From Baseline to Final Visit in Diastolic Blood Pressure (DBP).	Blood pressure response was defined as Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) less than the 95th percentile based on population height-adjusted charts for age and gender. Response rates were based on the proportion of patients meeting the criteria at each evaluation time point or the last available measure.	every 3 months - baseline to final visit

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Franz Schaefer, MD, University Children's Hospital, Heidelberg, Germany D69120

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (ACTUAL): September 1, 2009
• Study Completion (ACTUAL): September 1, 2009

Study Registration Dates

• First Submitted: June 2, 2008
• First Submitted That Met QC Criteria: June 2, 2008
• First Posted (ESTIMATE): June 4, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): July 12, 2011
• Last Update Submitted That Met QC Criteria: July 7, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: pediatric; renal disease; high blood pressure
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Candesartan; Candesartan cilexetil
• Other Study ID Numbers: D2451C00006