HypertensionPhase 3HIPNCT00690612
Study to Characterize the Long-term Clinical Experience of Atacand in Hypertensive Children Ages 1 to<11 Years (Hypertension in Pediatrics)
A Phase 3 study testing candesartan cilexetil in people with Hypertension, run by AstraZeneca at 13 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Hypertension
- What is being tested?
- candesartan cilexetil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 13 sitesin 6 countries
- Study dates
- Sep 2007to Sep 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
13 sites in 6 countries.
13 sites in 6 countries
Germany4 sites
Research Site
Erlangen
Research Site
Heidelberg
Research Site
Marburg
Research Site
Rostock
About this study
Official title: An Open-label Extension Study of Candesartan Cilexetil in Hypertensive Pediatric Subjects Ages 1 to <11 Years: a Long Term Study
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.
- Conditions
- Hypertension
- Being tested
- candesartan cilexetil
- Keywords
- pediatric, renal disease, high blood pressure
- Medical subject headings
- Hypertension, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
candesartan cilexetilDrug
Also called Atacand
0.05, 0.2, 0.4 mg/kg, oral solution, single daily dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | investigator determines efficacious dose based on child's BP response. Receives: Drug: candesartan cilexetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: every 3 months - baseline to final visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2008 (estimated)
- Study startSep 2007
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Franz Schaefer, MD, Principal investigator, University Children's Hospital, Heidelberg, Germany D69120
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00690612
- Sponsor's protocol ID
- D2451C00006
- Acronym
- HIP
- Status last verified
- Jul 2011
- First submitted
- 2 Jun 2008
- Last updated
- 12 Jul 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Extension Study of Candesartan Cilexetil in Hypertensive Pediatric Subjects Ages 1 to <11 Years: a Long Term Study
- ClinicalTrials.gov ID
- NCT00690612
- Acronym / sponsor ID
- HIP / D2451C00006
- Conditions
- Hypertension
- Keywords
- pediatric, renal disease, high blood pressure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 4 Jun 2008 (estimated)
- Results
- Posted 29 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: candesartan cilexetilinvestigator determines efficacious dose based on child's BP response. |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| candesartan cilexetilAlso: Atacand0.05, 0.2, 0.4 mg/kg, oral solution, single daily dose | Drug | 1 |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franz Schaefer, MD principal investigator
University Children's Hospital, Heidelberg, Germany D69120
13 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing candesartan cilexetil in people with Hypertension, run by AstraZeneca at 13 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Germany, Belgium, Italy, Poland, Ukraine and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline to Final Visit in Systolic Blood Pressure (SBP). (time frame: Every 3 months- baseline to final visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2011.