Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-26 @ 12:52 AM
Study NCT ID:
NCT00244634
Status:
COMPLETED
Last Update Posted:
2007-12-19
First Post:
2005-10-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Atacand Dose Range Finding Study in Pediatric Subjects 6 to <17 Years of Age
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 238}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-12-17', 'studyFirstSubmitDate': '2005-10-25', 'studyFirstSubmitQcDate': '2005-10-25', 'lastUpdatePostDateStruct': {'date': '2007-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Trough sitting systolic blood pressure, the measure of effect is change from baseline to double-blind Week 4.'}, {'measure': 'The endpoint (outcome variable) is the slope by linear regression'}], 'secondaryOutcomes': [{'measure': 'To further evaluate the antihypertensive effects and the safety of candesartan cilexetil in hypertensive pediatric subjects.'}, {'measure': 'Determine the slope of the change from baseline to double-blind treatment in:'}, {'measure': '• trough sitting diastolic blood pressure,'}, {'measure': '• trough standing diastolic blood pressure and standing systolic blood pressure,'}, {'measure': '• trough sitting pulse pressure.'}, {'measure': '- 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'}, {'measure': '- Safety as assessed by adverse events, adverse events that necessitate study drug discontinuation, SAEs, heart rate, electrocardiographic findings, physical exam findings, and laboratory tests.'}]}, 'conditionsModule': {'conditions': ['Pediatric Hypertension']}, 'descriptionModule': {'briefSummary': '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.\n\nSubjects 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.\n\nThe 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.\n\nAdditional analyses will include data pooled from a similar dose ranging study conducted in children 1 to \\< 6 years of age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female ages 6 to \\< 17 years-of-age after parent or guardian's signing of informed consent.\n\nSubjects with hypertension that is either:\n\n* 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\n* 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.\n\nFemales 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).\n\nA signed informed consent by a parent or a legal guardian and an assent form signed by the subject (if applicable).\n\nExclusion Criteria:\n\n* 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.\n* Hypertension secondary to coarctation of the aorta, pheochromocytoma, hyperthyroidism, Cushing's syndrome, or medications (eg: corticosteroids).\n* Known history of bilateral renal artery stenosis, unilateral renal artery stenosis or a renal transplant.\n* Glomerular filtration rate \\< 50 mL/min based on an estimated value using the Schwartz Formula.\n* Nephrotic syndrome not in remission.\n* Insulin dependent diabetes mellitus.\n* Known bleeding, coagulation, or platelet disorder that could interfere with blood sampling.\n* Clinically significant valvular heart disease.\n* Clinical diagnosis of heart failure.\n* Clinically significant arrhythmia (eg, any arrhythmia requiring medical therapy or that causes symptoms).\n* Second or third degree AV block.\n* Pregnant or breast-feeding an infant.\n* 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.\n* Known hypersensitivity to ARBs.\n* Unable to be off antihypertensive medication (diuretics, beta blockers, ACE Inhibitors, etc) for 6-weeks.\n* Inability to discontinue medications which may contribute to elevated blood pressure e.g. systemic corticosteroids.\n* 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.\n* Unable or unwilling to comply with the study requirements including blood sampling and swallowing study drug tablets.\n* Received an investigational agent within 30 days prior to receiving study medication.\n* Alcohol or drug abuse."}, 'identificationModule': {'nctId': 'NCT00244634', 'briefTitle': 'Atacand Dose Range Finding Study in Pediatric Subjects 6 to <17 Years of Age', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'D2451C00261'}, 'secondaryIdInfos': [{'id': '261A'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'candsartan cilexetil', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Madera', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 36.96134, 'lon': -120.06072}}, {'city': 'Yuba City', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.14045, 'lon': -121.61691}}, {'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Athens', 'state': 'Georgia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.96095, 'lon': -83.37794}}, {'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Park Ridge', 'state': 'Illinois', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.01114, 'lon': -87.84062}}, {'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 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48.10327, 'lon': 20.77806}}, {'city': 'Szeged', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, {'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'Research Site', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'city': 'Martin', 'country': 'Slovakia', 'facility': 'Research Site', 'geoPoint': {'lat': 49.06651, 'lon': 18.92399}}, {'city': 'Myjava', 'country': 'Slovakia', 'facility': 'Research Site', 'geoPoint': {'lat': 48.75876, 'lon': 17.56866}}, {'city': 'Trnava', 'country': 'Slovakia', 'facility': 'Research Site', 'geoPoint': {'lat': 48.37773, 'lon': 17.58603}}], 'overallOfficials': [{'name': 'AstraZeneca Atacand Medical Science Director, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}}}}