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Study to Characterize the Long-term Clinical Experience of Atacand in Hypertensive Children Ages 1 to<11 Years (HIP)
This study has been completed.
First Received: June 2, 2008   Last Updated: December 11, 2009   History of Changes
Sponsor: AstraZeneca
Information provided by: AstraZeneca
ClinicalTrials.gov Identifier: NCT00690612
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: candesartan cilexetil
Phase III

Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: An Open-label Extension Study of Candesartan Cilexetil in Hypertensive Pediatric Subjects Ages 1 to <11 Years: a Long Term Study

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • systolic blood pressure (SBP) and diastolic blood pressure (DBP) measurements [ Time Frame: It is expected that subjects will be examined in accordance with standard medical care of current medical conditions at protocol visits occurring every 3 months ] [ Designated as safety issue: No ]
  • Adverse events, including abnormal physical exam findings,laboratory test abnormalities, adverse events that necessitate drug discontinuation, and serious adverse events. [ Time Frame: It is expected that subjects will be examined in accordance with standard medical care of current medical conditions. Safety events are spontaneously reported or elicited during questioning and examination of the child/parents. ] [ Designated as safety issue: Yes ]

Enrollment: 35
Study Start Date: September 2007
Study Completion Date: September 2009
Arms Assigned Interventions
1: Experimental
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

  Eligibility

Ages Eligible for Study:   1 Year to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00690612

Locations
Belgium
Research Site
Edegem, Belgium
Research Site
Gent, Belgium
France
Research Site
Strasbourg Cedex, France
Germany
Research Site
Marburg, Germany
Research Site
Heidelberg, Germany
Research Site
Erlangen, Germany
Research Site
Rostock, Germany
Italy, GE
Research Site
Genova, GE, Italy
Italy, PD
Research Site
Padova, PD, Italy
Poland
Research Site
Gda�sk, Poland
Research Site
Krakow, Poland
Ukraine
Research Site
Crimea, Ukraine
Research Site
Kyiv, Ukraine
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Franz Schaefer, MD University Children's Hospital, Heidelberg, Germany D69120
  More Information

No publications provided

Responsible Party: AstraZeneca, LP ( James Hainer, MD, Sr. Director - Medical Research, Study Team Physician )
Study ID Numbers: D2451C00006
Study First Received: June 2, 2008
Last Updated: December 11, 2009
ClinicalTrials.gov Identifier: NCT00690612     History of Changes
Health Authority: United States: Food and Drug Administration;   Belgium: Federal Agency for Medicinal Products and Health Products;   France: Afssaps - French Health Products Safety Agency;   Germany: Federal Institute for Drugs and Medical Devices;   Italy: Ministry of Health;   Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products;   Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by AstraZeneca:
pediatric
renal disease
high blood pressure

Additional relevant MeSH terms:
Angiotensin II Type 1 Receptor Blockers
Candesartan cilexetil
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Candesartan
Vascular Diseases
Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010