Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT00227318
Status:
COMPLETED
Last Update Posted:
2011-08-30
First Post:
2005-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TROPHY - Candesartan Cilexetil Long-term Hypertension Prevention Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C077793', 'term': 'candesartan cilexetil'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION'}, 'enrollmentInfo': {'count': 1000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2005-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-29', 'studyFirstSubmitDate': '2005-09-26', 'studyFirstSubmitQcDate': '2005-09-26', 'lastUpdatePostDateStruct': {'date': '2011-08-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine whether candesartan cilexetil 16 mg compared to placebo reduces the crude incidence of hypertension in a population with high normal BP evaluated after a 4-year study period consisting of 2 years of double-blind treatment followed by 2 years'}], 'secondaryOutcomes': [{'measure': 'To evaluate the reduction in BP after 2 years treatment with candesartan cilexetil 16 mg vs placebo in patients with high normal BP.'}, {'measure': 'To evaluate the incidence of hypertension after 2 years treatment with candesartan cilexetil 16 mg vs placebo in patients with high normal BP.'}, {'measure': 'To evaluate Health-related Quality of Life yearly during 2 years treatment with candesartan cilexetil 16mg vs placebo and yearly during a 2-year follow up period in patients with high normal BP.'}]}, 'conditionsModule': {'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '16537662', 'type': 'RESULT', 'citation': 'Julius S, Nesbitt SD, Egan BM, Weber MA, Michelson EL, Kaciroti N, Black HR, Grimm RH Jr, Messerli FH, Oparil S, Schork MA; Trial of Preventing Hypertension (TROPHY) Study Investigators. Feasibility of treating prehypertension with an angiotensin-receptor blocker. N Engl J Med. 2006 Apr 20;354(16):1685-97. doi: 10.1056/NEJMoa060838. Epub 2006 Mar 14.'}, {'pmid': '25627429', 'type': 'DERIVED', 'citation': 'Kang S, Little RJ, Kaciroti N. Missing not at random models for masked clinical trials with dropouts. Clin Trials. 2015 Apr;12(2):139-48. doi: 10.1177/1740774514566662. Epub 2015 Jan 27.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effectiveness of candesartan cilexetil in preventing hypertension in people with high normal blood pressure. Patients will be randomized to either Candesartan or placebo for an initial 2-year period followed by a second 2-year period of placebo for all patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects between the ages of 30 and 65 (inclusive) at the time of the informed consent process\n* have an average clinic BP in the high normal range of \\< 139/85-89 mmHg or 130-139/\\< 89 mm Hg (high normal BP range) (mean systolic and/or diastolic pressure based on 3 consecutive measurements) derived from the average of clinic visits 1,2 and 3.\n\nExclusion Criteria:\n\n* Have proteinuria \\>1 + (by dipstick method)\n* have a stroke, myocardial infarction (MI), transient ischemic attack (TIA), the presence of any clinically significant evidence of atherosclerosis or hypertensive target organ involvement or any significant medical condition that may compromise participation in this study.'}, 'identificationModule': {'nctId': 'NCT00227318', 'briefTitle': 'TROPHY - Candesartan Cilexetil Long-term Hypertension Prevention Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Multicenter, Long-term Trial of Preventing Hypertension Using Candesartan Cilexetil 16 mg in Patients With High Normal Blood Pressure (TROPHY)', 'orgStudyIdInfo': {'id': 'SH-AHM-0030'}, 'secondaryIdInfos': [{'id': 'D2455L00010', 'type': 'OTHER', 'domain': 'AstraZeneca'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'ATACAND', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 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'Research Site', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Atacand Medical Science Director, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}