Atacand Dose Ranging in Hypertensive Pediatric Subjects 1 Year to Less Than 6 Years of Age
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: candesartan cilexetil (Atacand) (Drug); candesartan cilexetil (Atacand) (Drug); candesartan cilexetil (Atacand) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
AstraZeneca Atacand Medical Science Director, MD, Study Director, Affiliation: AstraZeneca
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. 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.
Clinical Details
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.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Mean Change From Baseline to Week 4 in Systolic Blood Pressure (SBP)
Secondary outcome: Mean Change From Baseline to Week 4 in Diastolic Blood Pressure (DBP)Change in Albumin/Creatinine (A/C) Ratio for Each Assigned Dose Level From Baseline to Day 28 Change in Protein/Creatinine (P/C) Ratio for Each Assigned Dose Level From Baseline to Day 28
Eligibility
Minimum age: 1 Year.
Maximum age: 6 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
- 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.
Locations and Contacts
Research Site, Edegem, Belgium
Research Site, Gent, Belgium
Research Site, Arhus, Denmark
Research Site, Strasbourg Cedex, France
Research Site, Berlin, Germany
Research Site, Erlangen, Germany
Research Site, Hamburg, Germany
Research Site, Heidelberg, Germany
Research Site, Marburg, Germany
Research Site, Rostock, Germany
Research Site, Genova, Italy
Research Site, Milano, Italy
Research Site, Padova, Italy
Research Site, Roma, Italy
Research Site, Gdansk, Poland
Research Site, Kraków, Poland
Research Site, Warszawa, Poland
Research Site, San Juan, Puerto Rico
Research Site, Crimea, Ukraine
Research Site, Kyiv, Ukraine
Research Site, London, United Kingdom
Research Site, Manchester, United Kingdom
Research Site, Birmingham, Alabama, United States
Research Site, Little Rock, Arkansas, United States
Research Site, Los Angeles, California, United States
Research Site, San Francisco, California, United States
Research Site, Miami, Florida, United States
Research Site, Orlando, Florida, United States
Research Site, Boise, Idaho, United States
Research Site, Detroit, Michigan, United States
Research Site, Durham, North Carolina, United States
Research Site, Cleveland, Ohio, United States
Research Site, Portland, Oregon, United States
Research Site, Malvern, Pennsylvania, United States
Research Site, Chattanooga, Tennessee, United States
Research Site, Beaumont, Texas, United States
Research Site, Houston, Texas, United States
Research Site, San Antonio, Texas, United States
Additional Information
Starting date: November 2004
Last updated: August 29, 2011
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