Study to Characterize the Long-term Clinical Experience of Atacand in Hypertensive Children Ages 1 to<11 Years (Hypertension in Pediatrics)
Condition: Hypertension
MeSH terms: Hypertension
Intervention: candesartan cilexetil
Intervention description: 0.05, 0.2, 0.4 mg/kg, oral solution, single daily dose
Intervention MeSH terms: Candesartan; Candesartan cilexetil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 1 Year
Maximum age: 10 Years
Healthy volunteers: No
Keywords: pediatric; renal disease; high blood pressure

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.