Study to Characterize the Long-term Clinical Experience of Atacand in Hypertensive Children Ages 1 to<11 Years (Hypertension in Pediatrics) (HIP)
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|ClinicalTrials.gov Identifier: NCT00690612|
Recruitment Status : Completed
First Posted : June 4, 2008
Results First Posted : June 29, 2011
Last Update Posted : July 12, 2011
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Drug: candesartan cilexetil||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label Extension Study of Candesartan Cilexetil in Hypertensive Pediatric Subjects Ages 1 to <11 Years: a Long Term Study|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||September 2009|
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 Name: Atacand
- Mean Change From Baseline to Final Visit in Systolic Blood Pressure (SBP). [ Time Frame: Every 3 months- baseline to final visit ]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.
- Mean Change From Baseline to Final Visit in Diastolic Blood Pressure (DBP). [ Time Frame: every 3 months - baseline to final visit ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00690612
|Strasbourg Cedex, France|
|Genova, GE, Italy|
|Padova, PD, Italy|
|Principal Investigator:||Franz Schaefer, MD||University Children's Hospital, Heidelberg, Germany D69120|