HypertensionPhase 3NCT00244621
Atacand Dose Ranging in Hypertensive Pediatric Subjects 1 Year to Less Than 6 Years of Age
A Phase 3 study testing candesartan cilexetil (Atacand) in people with Hypertension, run by AstraZeneca at 38 sites in 10 countries.
Trial summary
This is a dose ranging study of candesartan cilexetil in hypertensive pediatric subjects ages 1 to less than 6 years of age. It employs a double blind, randomized, dose ranging design intended for conduct as a multicenter trial. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Hypertension
- What is being tested?
- candesartan cilexetil (Atacand)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 38 sitesin 10 countries
- Study dates
- Nov 2004to Aug 2008
- 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 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Signed informed consent by a parent or a legal guardian.
- Weight > 10 kg and < 40 kg.
- SiSBP and/or SiDBP > 95th percentile and < 20 mm Hg (systolic) and/or 10 mm Hg (diastolic) above the 95th percentile at screening and at randomization based on height-adjusted charts for age and gender.
Who cannot join
- Any situation, clinical condition or laboratory abnormality that, in the opinion of the investigator or sponsor, may interfere with the subject's participation in the study or would pose a significant risk to the subject or interfere with the assessment of safety and efficacy endpoints.
- Weight < 10 kg and > 40 kg.
- Less than 80% compliance with study medication during single-blind placebo screening as assessed by residual medication volume.
- Hypertension secondary to pheochromocytoma, hyperthyroidism, or Cushing's Syndrome.
- Uncorrected coarctation of the aorta, bilateral renal artery renal artery stenosis in a single kidney.
- Estimated glomerular filtration rate (GFR) < 50 mL/min/1.73m 2 based on the Schwartz Formula (Schwartz et al, 1987).
Show all 21Show fewer
- Renal transplant < 6 months prior to study entry. Subjects who have received a renal transplant > 6 months prior to study entry may participate in the study if: 1) renal function is stable, 2) estimated GFR >50 mL/min/1.73m 2, 3) stable doses of immunosuppressive medications are anticipated throughout the 4-week, double-blind period of the study, 4) no episodes of acute allograft rejection have occurred within 30 days of study entry, and 5) the renal allograft has no documented renal artery stenosis.
- Nephrotic syndrome not in remission.
- Unstable insulin dependent diabetes mellitus.
- Known bleeding, coagulation, or platelet disorder that could interfere with blood sampling.
- Clinically significant valvular heart disease.
- Clinical diagnosis of heart failure.
- Clinically significant arrhythmia (eg, any arrhythmia requiring medical therapy or that causes symptoms).
- Second or third degree AV block.
- Impaired liver function defined as either acute liver disease or chronic liver disease with persistent liver enzyme values greater than 1½ times the upper limit of the reference range for aspartate aminotransferase (AST) or alanine aminotransferase (ALT).
- Known hypersensitivity to ARBs.
- Currently receiving an angiotensin receptor blocker or an angiotensin converting enzyme inhibitor that in the investigator's judgment cannot safely be withdrawn during the study.
- Subjects receiving an angiotensin receptor blocker or an angiotensin converting enzyme inhibitor may be eligible if they undergo withdrawal of the antihypertensive medication over a 2-week washout period and subsequently meet BP inclusion/exclusion criteria.
- Subjects currently receiving other classes of antihypertensive medications (eg, diuretics, calcium channel blockers or beta-blockers) and whose BP values meet inclusion/exclusion criteria may participate in the study while continuing their current antihypertensive medication regimen. Up to 2 concomitant antihypertensive medications are permitted. Doses and dose regimens of concomitant antihypertensive medications must remain unchanged during the 4-week double-blind period of the study.
- Currently using, or used within 14 days prior to receiving double-blind medication, any concomitant medications which in the opinion of the investigator could negatively affect the subject.
- Unable or unwilling to comply with the study requirements including blood sampling and swallowing study drug suspension.
Trial locations and contacts
38 sites in 10 countries.
38 sites in 10 countries
United States16 sites
Research Site
Beaumont, Texas
Research Site
Birmingham, Alabama
Research Site
Boise, Idaho
Research Site
Chattanooga, Tennessee
Research Site
Cleveland, Ohio
Research Site
Detroit, Michigan
Research Site
Durham, North Carolina
Research Site
Houston, Texas
Research Site
Little Rock, Arkansas
Research Site
Los Angeles, California
Research Site
Malvern, Pennsylvania
Research Site
Miami, Florida
Research Site
Orlando, Florida
Research Site
Portland, Oregon
Research Site
San Antonio, Texas
Research Site
San Francisco, California
Germany6 sites
Research Site
Berlin
Research Site
Erlangen
Research Site
Hamburg
Research Site
Heidelberg
Research Site
Marburg
Research Site
Rostock
Italy4 sites
Research Site
Genova
Research Site
Milan
Research Site
Padova
Research Site
Roma
About this study
Official title: A Dose-ranging Safety and Pharmacokinetics Study of Candesartan Cilexetil in Hypertensive Pediatric Subjects 1 to Less That 6 Years of Age: A 4-week, Multicenter, Randomized, Double-blind Study With a 1-year, Open-label, Follow-up Period.
This is a dose ranging study of candesartan cilexetil in hypertensive pediatric subjects ages 1 to less than 6 years of age. It employs a double blind, randomized, dose ranging design intended for conduct as a multicenter trial. There are 3 study 'periods': a 1-week placebo run-in, a 4-week double blind treatment, and a 52-week open-label, long-term treatment period. Subjects undergo a screening evaluation, then a 1-week single-blind, placebo run-in, after which eligible subjects are allocated to receive 1 of 3 dose levels of candesartan cilexetil (0.05 mg/kg, or 0.20 mg /kg or 0.40 mg /kg), liquid formulation, in a 1:1:1 ratio for 4-weeks. At the end of randomized dose allocation (Day 28), blood pressure assessment will be performed and subjects may begin the 52-week, open-label treatment period of the study.
- Conditions
- Hypertension
- Being tested
- candesartan cilexetil (Atacand)
- Keywords
- Pediatric hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
candesartan cilexetil (Atacand)Drug
Also called Atacand
0.05 mg/kg once daily oral liquid dose
candesartan cilexetil (Atacand)Drug
Also called ATACAND
0.20 mg/kg once daily oral liquid dose
candesartan cilexetil (Atacand)Drug
Also called ATACAND
0.40 mg/kg once daily oral liquid dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 0.05 mg/kg Atacand oral liquid dose Receives: Drug: candesartan cilexetil (Atacand) |
| 2 | Experimental | 0.20 mg /kg Atacand oral liquid dose Receives: Drug: candesartan cilexetil (Atacand) |
| 3 | Experimental | 0.40 mg /kg Atacand oral liquid dose Receives: Drug: candesartan cilexetil (Atacand) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline to Week 4 in Systolic Blood Pressure (SBP)
Measured: From randomisation to end of double-blind treatment (4 weeks)
Secondary outcomes (3)
Mean Change From Baseline to Week 4 in Diastolic Blood Pressure (DBP)
Measured: From randomisation to end of double-blind treatment (4 weeks)
Change in Albumin/Creatinine (A/C) Ratio for Each Assigned Dose Level From Baseline to Day 28
Measured: From randomisation to day 28
Change in Protein/Creatinine (P/C) Ratio for Each Assigned Dose Level From Baseline to Day 28
Measured: From randomisation to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2005 (estimated)
- Study startNov 2004
- Primary completionAug 2008
- Study completionAug 2008
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AstraZeneca Atacand Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00244621
- Sponsor's protocol ID
- D2451C00002
- Other IDs
- 328
- Status last verified
- Aug 2011
- First submitted
- 25 Oct 2005
- Last updated
- 31 Aug 2011
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Schaefer F, van de Walle J, Zurowska A, Gimpel C, van Hoeck K, Drozdz D, Montini G, Bagdasorova IV, Sorof J, Sugg J, Teng R, Hainer JW; Candesartan in Children with Hypertension Investigators. Efficacy, safety and pharmacokinetics of candesartan cilexetil in hypertensive children from 1 to less than 6 years of age. J Hypertens. 2010 May;28(5):1083-90. doi: 10.1097/HJH.0b013e328336b86b.
PubMed 20160654
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-ranging Safety and Pharmacokinetics Study of Candesartan Cilexetil in Hypertensive Pediatric Subjects 1 to Less That 6 Years of Age: A 4-week, Multicenter, Randomized, Double-blind Study With a 1-year, Open-label, Follow-up Period.
- ClinicalTrials.gov ID
- NCT00244621
- Acronym / sponsor ID
- D2451C00002
- Conditions
- Hypertension
- Keywords
- Pediatric hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 27 Oct 2005 (estimated)
- Results
- Posted 15 Sep 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a dose ranging study of candesartan cilexetil in hypertensive pediatric subjects ages 1 to less than 6 years of age. It employs a double blind, randomized, dose ranging design intended for conduct as a multicenter trial. There are 3 study 'periods': a 1-week placebo run-in, a 4-week double blind treatment, and a 52-week open-label, long-term treatment period. Subjects undergo a screening evaluation, then a 1-week single-blind, placebo run-in, after which eligible subjects are allocated to receive 1 of 3 dose levels of candesartan cilexetil (0.05 mg/kg, or 0.20 mg /kg or 0.40 mg /kg), liquid formulation, in a 1:1:1 ratio for 4-weeks. At the end of randomized dose allocation (Day 28), blood pressure assessment will be performed and subjects may begin the 52-week, open-label treatment period of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: candesartan cilexetil (Atacand)0.05 mg/kg Atacand oral liquid dose |
| 2 | Experimental | Drug: candesartan cilexetil (Atacand)0.20 mg /kg Atacand oral liquid dose |
| 3 | Experimental | Drug: candesartan cilexetil (Atacand)0.40 mg /kg Atacand oral liquid dose |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Signed informed consent by a parent or a legal guardian.
- Weight > 10 kg and < 40 kg.
- SiSBP and/or SiDBP > 95th percentile and < 20 mm Hg (systolic) and/or 10 mm Hg (diastolic) above the 95th percentile at screening and at randomization based on height-adjusted charts for age and gender.
Key exclusion criteria (21 listed)
- Any situation, clinical condition or laboratory abnormality that, in the opinion of the investigator or sponsor, may interfere with the subject's participation in the study or would pose a significant risk to the subject or interfere with the assessment of safety and efficacy endpoints.
- Weight < 10 kg and > 40 kg.
- Less than 80% compliance with study medication during single-blind placebo screening as assessed by residual medication volume.
- Hypertension secondary to pheochromocytoma, hyperthyroidism, or Cushing's Syndrome.
- Uncorrected coarctation of the aorta, bilateral renal artery renal artery stenosis in a single kidney.
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 cilexetil (Atacand)Also: Atacand0.05 mg/kg once daily oral liquid dose | Drug | 1 |
| candesartan cilexetil (Atacand)Also: ATACAND0.20 mg/kg once daily oral liquid dose | Drug | 2 |
| candesartan cilexetil (Atacand)Also: ATACAND0.40 mg/kg once daily oral liquid dose | Drug | 3 |
Primary outcome
Mean Change From Baseline to Week 4 in Systolic Blood Pressure (SBP)
Time frame: From randomisation to end of double-blind treatment (4 weeks)
3 secondary outcomes
Mean Change From Baseline to Week 4 in Diastolic Blood Pressure (DBP)
Time frame: From randomisation to end of double-blind treatment (4 weeks)
Change in Albumin/Creatinine (A/C) Ratio for Each Assigned Dose Level From Baseline to Day 28
Time frame: From randomisation to day 28
Change in Protein/Creatinine (P/C) Ratio for Each Assigned Dose Level From Baseline to Day 28
Time frame: From randomisation to day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20160654Schaefer F, van de Walle J, Zurowska A, Gimpel C, van Hoeck K, Drozdz D, Montini G, Bagdasorova IV, Sorof J, Sugg J, Teng R, Hainer JW; Candesartan in Children with Hypertension Investigators. Efficacy, safety and pharmacokinetics of candesartan cilexetil in hypertensive children from 1 to less than 6 years of age. J Hypertens. 2010 May;28(5):1083-90. doi: 10.1097/HJH.0b013e328336b86b.
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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.
AstraZeneca Atacand Medical Science Director, MD study director
AstraZeneca
38 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing candesartan cilexetil (Atacand) in people with Hypertension, run by AstraZeneca at 38 sites in 10 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 3 inclusion and 21 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 31 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Germany, Italy, Poland, Belgium and 5 more countries. 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 15 Sep 2009). 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 Week 4 in Systolic Blood Pressure (SBP) (time frame: From randomisation to end of double-blind treatment (4 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00244621, which also lists 1 linked publication.
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 31 Aug 2011; AzTrials last refreshed its copy on 26 Oct 2026.