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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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 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-label Extension Study of Candesartan Cilexetil in Hypertensive Pediatric Subjects Ages 1 to <11 Years: a Long Term Study |
- Mean Change From Baseline to Final Visit in Systolic Blood Pressure (SBP). [ Time Frame: Every 3 months- baseline to final visit ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
| Enrollment: | 35 |
| Study Start Date: | September 2007 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
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
|
Eligibility| Ages Eligible for Study: | 1 Year to 10 Years |
| Genders Eligible for Study: | Both |
| Accepts 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.
Contacts and Locations| Belgium | |
| Research Site | |
| Edegem, Belgium | |
| Research Site | |
| Gent, Belgium | |
| France | |
| Research Site | |
| Strasbourg Cedex, France | |
| Germany | |
| Research Site | |
| Erlangen, Germany | |
| Research Site | |
| Heidelberg, Germany | |
| Research Site | |
| Marburg, Germany | |
| Research Site | |
| Rostock, Germany | |
| Italy | |
| Research Site | |
| Genova, GE, Italy | |
| Research Site | |
| Padova, PD, Italy | |
| Poland | |
| Research Site | |
| Gda�sk, Poland | |
| Research Site | |
| Krakow, Poland | |
| Ukraine | |
| Research Site | |
| Crimea, Ukraine | |
| Research Site | |
| Kyiv, Ukraine | |
| Principal Investigator: | Franz Schaefer, MD | University Children's Hospital, Heidelberg, Germany D69120 |
More Information
No publications provided
| Responsible Party: | James Hainer, MD, Sr. Director - Medical Research, Study Team Physician, AstraZeneca, LP |
| ClinicalTrials.gov Identifier: | NCT00690612 History of Changes |
| Other Study ID Numbers: | D2451C00006 |
| Study First Received: | June 2, 2008 |
| Results First Received: | August 31, 2010 |
| Last Updated: | July 7, 2011 |
| Health Authority: | United States: Food and Drug Administration Belgium: Federal Agency for Medicinal Products and Health Products France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) 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:
|
Hypertension Vascular Diseases Cardiovascular Diseases Candesartan cilexetil Candesartan Angiotensin II Type 1 Receptor Blockers |
Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antihypertensive Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013