Status:
COMPLETED
Study to Characterize the Long-term Clinical Experience of Atacand in Hypertensive Children Ages 1 to<11 Years (Hypertension in Pediatrics)
Lead Sponsor:
AstraZeneca
Conditions:
Hypertension
Eligibility:
All Genders
1-10 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00690612
Start Date
September 1 2007
End Date
September 1 2009
Last Update
July 12 2011
Active Locations (13)
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1
Research Site
Edegem, Belgium, Belgium
2
Research Site
Ghent, Belgium, Belgium
3
Research Site
Strasbourg, France
4
Research Site
Erlangen, Germany