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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | investigator determines efficacious dose based on child's BP response. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| candesartan cilexetil | Drug | 0.05, 0.2, 0.4 mg/kg, oral solution, single daily dose |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Every 3 months- baseline to final visit |
| 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. | every 3 months - baseline to final visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Franz Schaefer, MD | University Children's Hospital, Heidelberg, Germany D69120 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Edegem | Belgium | Belgium | |||
| Research Site |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Ghent |
| Belgium |
| Belgium |
| Research Site | Strasbourg | France |
| Research Site | Erlangen | Germany |
| Research Site | Heidelberg | Germany |
| Research Site | Marburg | Germany |
| Research Site | Rostock | Germany |
| Research Site | Genova | GE | Italy |
| Research Site | Padova | PD | Italy |
| Research Site | Gda�sk | Poland |
| Research Site | Krakow | Poland |
| Research Site | Crimea | Ukraine |
| Research Site | Kyiv | Ukraine |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | Millimeters of Mercury (mm Hg) | Every 3 months- baseline to final visit |
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| 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. | Posted | Mean | Standard Deviation | mm Hg | every 3 months - baseline to final visit |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 3 | 35 | 28 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchopneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Lymphoedema | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA (10.0) | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| PHARYNGITIS | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| RHINITIS | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| BRONCHITIS | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| VARICELLA | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| ACUTE TONSILLITIS | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| GASTROENTERITIS | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| INFLUENZA | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| OTITIS MEDIA | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| OTITIS MEDIA ACUTE | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| TONSILLITIS | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| ENURESIS | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFLAMMATION | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C077793 | candesartan cilexetil |
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