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| Sponsor: | AstraZeneca |
|---|---|
| Information provided by: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00690612 |
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 |
| 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:
Exclusion Criteria:
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
| 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 - French Health Products Safety Agency 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 |
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pediatric renal disease high blood pressure |
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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 |