Hypertension
Conditions
Keywords
pediatric, renal disease, high blood pressure
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 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.
Interventions
DRUGcandesartan cilexetil
0.05, 0.2, 0.4 mg/kg, oral solution, single daily dose
Sponsors
AstraZeneca
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 10 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline to Final Visit in Systolic Blood Pressure (SBP). | 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). | 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. |
Countries
Belgium, France, Germany, Italy, Poland, Ukraine
Participant flow
Recruitment details
Hypertensive children aged 1 to \<11 years who had participated in the 1-year study (Protocol 328, D2451C00002-NCT00244621). First patient enrolled 17 Sep 2007 and last patient completed 9 Sep 2009 at Pediatric clinics in Europe.
Pre-assignment details
Patients who had participated in the 1-year study (Protocol 328, D2451C00002-NCT00244621) and did not discontinue study due to a study drug-related adverse event (AE) and had an ongoing clinical indication for treatment with candesartan.
Participants by arm
| Arm | Count |
|---|---|
| Atacand Candesartan Cilexetil candesartan cilexetil (Atacand) approximately 0.05 mg/kg, 0.2 mg/kg, and 0.4 mg/kg doses administered in oral suspension form. | 35 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Atacand Candesartan Cilexetil |
|---|---|
| Age Continuous <=11 years | 4.4 Years STANDARD_DEVIATION 1.6 |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 28 / 35 |
| serious Total, serious adverse events | 3 / 35 |
Outcome results
Primary
Mean Change From Baseline to Final Visit in Diastolic Blood Pressure (DBP).
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.
Time frame: every 3 months - baseline to final visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atacand Candesartan Cilexetil | Mean Change From Baseline to Final Visit in Diastolic Blood Pressure (DBP). | -0.43 mm Hg | Standard Deviation 12.26 |
Primary
Mean Change From Baseline to Final Visit in Systolic Blood Pressure (SBP).
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.
Time frame: Every 3 months- baseline to final visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atacand Candesartan Cilexetil | Mean Change From Baseline to Final Visit in Systolic Blood Pressure (SBP). | -2.86 Millimeters of Mercury (mm Hg) | Standard Deviation 11.97 |