Pediatric HypertensionPhase 3NCT00244634
Atacand Dose Range Finding Study in Pediatric Subjects 6 to <17 Years of Age
A Phase 3 study testing candsartan cilexetil in people with Pediatric Hypertension, run by AstraZeneca at 44 sites in 4 countries.
Trial summary
Study 261A is a dose-ranging and safety study of candesartan cilexetil. It is a multinational, multicenter, randomized, double-blind, placebo-controlled, parallel-group study with a 4 week treatment period in hypertensive pediatric subjects. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Pediatric Hypertension
- What is being tested?
- candsartan cilexetil
- How many people
- 238 participants
- Where
- 44 sitesin 4 countries
- Study dates
- Sep 2003to Nov 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female ages 6 to < 17 years-of-age after parent or guardian's signing of informed consent.
- Subjects with hypertension that is either:
- Diagnosed and untreated with a mean sitting systolic and/or diastolic blood pressure ≥ 95th percentile and ≤ 20 mm Hg (systolic) and/or 10 mm Hg (diastolic) above the 95th percentile at randomisation based on height-adjusted charts for age and gender; or
- Previously diagnosed and currently treated with mean sitting systolic blood pressure and/or diastolic blood pressure ≥ 95th percentile and ≤ 20 mm Hg (systolic) and/or 10 mm Hg (diastolic) above the 95th percentile at randomisation (off treatment) based on height-adjusted charts for age and gender.
- Females of childbearing potential (post-menarche) must have a negative urine pregnancy test prior to randomization and adhere to a pregnancy prevention method (abstinence, barrier method plus spermicidal foam, oral, or implanted contraceptive).
- A signed informed consent by a parent or a legal guardian and an assent form signed by the subject (if applicable).
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.
- Hypertension secondary to coarctation of the aorta, pheochromocytoma, hyperthyroidism, Cushing's syndrome, or medications (eg: corticosteroids).
- Known history of bilateral renal artery stenosis, unilateral renal artery stenosis or a renal transplant.
- Glomerular filtration rate < 50 mL/min based on an estimated value using the Schwartz Formula.
- Nephrotic syndrome not in remission.
- Insulin dependent diabetes mellitus.
Show all 20Show fewer
- 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.
- Pregnant or breast-feeding an infant.
- 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 AST or ALT.
- Known hypersensitivity to ARBs.
- Unable to be off antihypertensive medication (diuretics, beta blockers, ACE Inhibitors, etc) for 6-weeks.
- Inability to discontinue medications which may contribute to elevated blood pressure e.g. systemic corticosteroids.
- 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 tablets.
- Received an investigational agent within 30 days prior to receiving study medication.
- Alcohol or drug abuse.
Trial locations and contacts
44 sites in 4 countries.
44 sites in 4 countries
United States36 sites
Research Site
Ann Arbor, Michigan
Research Site
Athens, Georgia
Research Site
Augusta, Georgia
Research Site
Beaumont, Texas
Research Site
Beverly Hills, California
Research Site
Brooklyn, New York
Research Site
Charleston, South Carolina
Research Site
Charleston, West Virginia
Research Site
Charlotte, North Carolina
Research Site
Charlottesville, Virginia
Research Site
Chicago, Illinois
Research Site
Cincinnati, Ohio
Research Site
Cleveland, Ohio
Research Site
Columbus, Ohio
Research Site
Houston, Texas
Research Site
Jackson, Mississippi
Research Site
Las Vegas, Nevada
Research Site
Los Angeles, California
Research Site
Louisville, Kentucky
Research Site
Madera, California
Research Site
Miami, Florida
Research Site
New Hyde Park, New York
Research Site
Newark, Delaware
Research Site
Norfolk, Virginia
Research Site
Park Ridge, Illinois
Research Site
Paterson, New Jersey
Research Site
Philadelphia, Pennsylvania
Research Site
Pittsburgh, Pennsylvania
Research Site
Port Gibson, Mississippi
Research Site
Portland, Oregon
Research Site
Salt Lake City, Utah
Research Site
St Louis, Missouri
Research Site
The Bronx, New York
Research Site
Wilmington, Delaware
Research Site
Winston-Salem, North Carolina
Research Site
Yuba City, California
Slovakia4 sites
Research Site
Bratislava
Research Site
Martin
Research Site
Myjava
Research Site
Trnava
Hungary3 sites
Research Site
Budapest
Research Site
Miskolc
Research Site
Szeged
About this study
Official title: A Dose-Ranging and Safety Study of Candesartan Cilexetil in Hypertensive Pediatric Subjects 6 to <17 Years of Age: A 4-Week, Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study
Study 261A is a dose-ranging and safety study of candesartan cilexetil. It is a multinational, multicenter, randomized, double-blind, placebo-controlled, parallel-group study with a 4 week treatment period in hypertensive pediatric subjects.
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 or placebo. The study includes 2 panels based on subject weight.
Read more
The primary efficacy analysis is based on the intent-to-treat population and tests for slope = 0 in a linear regression model with change in sitting systolic blood pressure as the dependent and non-zero dose pooled across weight panels as the independent variable. For subjects without a Double-Blind Week 4 blood pressure determination, carrying the last value forward assigns the value.
Additional analyses will include data pooled from a similar dose ranging study conducted in children 1 to < 6 years of age.
- Conditions
- Pediatric Hypertension
- Being tested
- candsartan cilexetil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
candsartan cilexetilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Trough sitting systolic blood pressure, the measure of effect is change from baseline to double-blind Week 4.
The endpoint (outcome variable) is the slope by linear regression
Secondary outcomes (7)
To further evaluate the antihypertensive effects and the safety of candesartan cilexetil in hypertensive pediatric subjects.
Determine the slope of the change from baseline to double-blind treatment in:
• trough sitting diastolic blood pressure,
• trough standing diastolic blood pressure and standing systolic blood pressure,
• trough sitting pulse pressure.
- Mean change from baseline in SiSBP, SiDBP, pulse pressure, and standing SBP and DBP relative to placebo for each dose group and for all dose groups pooled
- Safety as assessed by adverse events, adverse events that necessitate study drug discontinuation, SAEs, heart rate, electrocardiographic findings, physical exam findings, and laboratory tests.
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 startSep 2003
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric 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
- Double blind
- Enrolment
- 238 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Atacand Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00244634
- Sponsor's protocol ID
- D2451C00261
- Other IDs
- 261A
- Status last verified
- Dec 2007
- First submitted
- 25 Oct 2005
- Last updated
- 19 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-Ranging and Safety Study of Candesartan Cilexetil in Hypertensive Pediatric Subjects 6 to <17 Years of Age: A 4-Week, Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study
- ClinicalTrials.gov ID
- NCT00244634
- Acronym / sponsor ID
- D2451C00261
- Conditions
- Pediatric Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2003
- Study completion
- Nov 2005 (actual)
- First posted
- 27 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study 261A is a dose-ranging and safety study of candesartan cilexetil. It is a multinational, multicenter, randomized, double-blind, placebo-controlled, parallel-group study with a 4 week treatment period in hypertensive pediatric subjects.
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 or placebo. The study includes 2 panels based on subject weight.
The primary efficacy analysis is based on the intent-to-treat population and tests for slope = 0 in a linear regression model with change in sitting systolic blood pressure as the dependent and non-zero dose pooled across weight panels as the independent variable. For subjects without a Double-Blind Week 4 blood pressure determination, carrying the last value forward assigns the value.
Additional analyses will include data pooled from a similar dose ranging study conducted in children 1 to < 6 years of age.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Male or female ages 6 to < 17 years-of-age after parent or guardian's signing of informed consent.
- Diagnosed and untreated with a mean sitting systolic and/or diastolic blood pressure ≥ 95th percentile and ≤ 20 mm Hg (systolic) and/or 10 mm Hg (diastolic) above the 95th percentile at randomisation based on height-adjusted charts for age and gender; or
- Previously diagnosed and currently treated with mean sitting systolic blood pressure and/or diastolic blood pressure ≥ 95th percentile and ≤ 20 mm Hg (systolic) and/or 10 mm Hg (diastolic) above the 95th percentile at randomisation (off treatment) based on height-adjusted charts for age and gender.
- Females of childbearing potential (post-menarche) must have a negative urine pregnancy test prior to randomization and adhere to a pregnancy prevention method (abstinence, barrier method plus spermicidal foam, oral, or implanted contraceptive).
- A signed informed consent by a parent or a legal guardian and an assent form signed by the subject (if applicable).
Key exclusion criteria (20 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.
- Hypertension secondary to coarctation of the aorta, pheochromocytoma, hyperthyroidism, Cushing's syndrome, or medications (eg: corticosteroids).
- Known history of bilateral renal artery stenosis, unilateral renal artery stenosis or a renal transplant.
- Glomerular filtration rate < 50 mL/min based on an estimated value using the Schwartz Formula.
- Nephrotic syndrome not in remission.
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 |
|---|---|---|
| candsartan cilexetil | Drug | – |
Primary outcome
Trough sitting systolic blood pressure, the measure of effect is change from baseline to double-blind Week 4.
The endpoint (outcome variable) is the slope by linear regression
7 secondary outcomes
To further evaluate the antihypertensive effects and the safety of candesartan cilexetil in hypertensive pediatric subjects.
Determine the slope of the change from baseline to double-blind treatment in:
• trough sitting diastolic blood pressure,
• trough standing diastolic blood pressure and standing systolic blood pressure,
• trough sitting pulse pressure.
- Mean change from baseline in SiSBP, SiDBP, pulse pressure, and standing SBP and DBP relative to placebo for each dose group and for all dose groups pooled
- Safety as assessed by adverse events, adverse events that necessitate study drug discontinuation, SAEs, heart rate, electrocardiographic findings, physical exam findings, and laboratory tests.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2007.
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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
44 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing candsartan cilexetil in people with Pediatric Hypertension, run by AstraZeneca at 44 sites in 4 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 6 inclusion and 20 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 19 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States, Slovakia, Hungary, Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Trough sitting systolic blood pressure, the measure of effect is change from baseline to double-blind Week 4.. 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 19 Dec 2007.