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

NCT00690612 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2011-07-12

Study results available
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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.

Conditions

Interventions

DRUG

candesartan cilexetil

0.05, 0.2, 0.4 mg/kg, oral solution, single daily dose

Sponsors & Collaborators

Principal Investigators

  • Franz Schaefer, MD · University Children's Hospital, Heidelberg, Germany D69120

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • Belgium
  • France
  • Germany
  • Italy
  • Poland
  • Ukraine

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00690612 on ClinicalTrials.gov