Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT00265967
Status:
COMPLETED
Last Update Posted:
2009-12-07
First Post:
2005-12-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Irbesartan in Hypertension
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': 'D000077405', 'term': 'Irbesartan'}], 'ancestors': [{'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013141', 'term': 'Spiro Compounds'}, {'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'lastUpdateSubmitDate': '2009-12-04', 'studyFirstSubmitDate': '2005-12-14', 'studyFirstSubmitQcDate': '2005-12-14', 'lastUpdatePostDateStruct': {'date': '2009-12-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in 24 hours mean ambulatory blood pressure on the missing dose day. Frequency, severity, seriousness of adverse events emerging during the treatment , and their relation with the study drug.', 'timeFrame': 'at the end of 6th months to 8th'}], 'secondaryOutcomes': [{'measure': "Diastolic blood pressure measurements recorded in patients' diaries, and during visits.", 'timeFrame': '6-8 weeks'}]}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'Study objectives:\n\n* To demonstrate the effect of irbesartan on the regulation of diastolic blood pressure, in case of missing one dose after a period of administration for 6 to 8 weeks\n* To evaluate the safety of irbesartan'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Having an average value of ≥ 95 mmHg and ≤ 109 mmHg in diastolic blood pressure measurement or an average diastolic blood pressure value of ≥ 85 mmHg in 24-hours arterial blood pressure measurement,\n* Received no treatment within the last 3 months.\n\nExclusion Criteria:\n\n* Premenopausal women having at least one of the following conditions,\n\n * Not surgically sterile,\n * Are nursing,\n * Having childbearing potential and not using a reasonable contraception method or not thinking to continue the method throughout the study. Reasonable contraception methods are: intrauterine device, oral or implantable or injectable contraception methods. No methods other than these are accepted.\n* Patients routinely sleeping within the day since she/he works at nightshift and whose working hours continue in a time shift from midnight to 04:00 A.M.\n* Patients with average systolic blood pressure = 180 mmHg in sitting position or average diastolic blood pressure is ≥110 mmHg in sitting position at baseline visit\n* Having known or suspected secondary hypertension\n* Having renal and/or hepatic failure together with the following laboratory criteria:\n\n * Having elevated values of SGPT (ALT) or SGOT (ALT) (at least twice the upper limit of normal range)\n * Having serum creatinine levels of \\> 2.3 mg/dL (or \\> 203 μmol/L)\n* With bilateral renal artery stenosis or single kidney and unilateral renal artery stenosis or those in post-renal transplantation or with single kidney,\n* Having symptomatic sodium insufficiency, hypokalemia or hyperkalemia,\n* With volume deficiency,\n* With primary hyperaldosteronism,\n* With biliary obstructive disorders,\n* Having congestive heart failure (New York Heart Association (NYHA)-functional class CHF III-IV),\n* With unstable angina pectoris occurring within 3 months before he or she signed the informed consent.\n* With stroke occurring within 6 months before he or she signed the informed consent,\n* With myocardial infarction or having cardiac surgery within three months before he or she signed the informed consent,\n* Underwent PTCA (percutaneous transluminal coronary revascularization) within three months before he or she signed the informed consent,\n* Having continuous tachycardia, atrial fibrillation, atrial flutter or other clinical arrythmias defined by the investigator\n* With hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically related aortic or mitral valve stenosis,\n* With insulin-dependant diabetes mellitus whose blood sugar regulation could not be controlled within the last 3 months after a HbA1C measurement in which it is equal to 10%.\n* With a history of drug or alcohol addiction within the last 6 months before she or he signed the informed consent,\n* Receiving a drug other than those defined in protocol for blood pressure regulation,\n* Who have been participated in any investigational study within the prior month before she or he signed the informed consent\n* With a known hypersensitivity against any drug which will be used.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT00265967', 'briefTitle': 'Irbesartan in Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Missed Dose Effect of Irbesartan in Hypertensive Patients and Cardiovascular Risk Profile Monitoring Under Irbesartan Treatment', 'orgStudyIdInfo': {'id': 'L_9917'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Irbesartan', 'interventionNames': ['Drug: Irbesartan']}], 'interventions': [{'name': 'Irbesartan', 'type': 'DRUG', 'description': 'Irbesartan 150-300 mg/d for 8 weeks', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Edibe Taylan', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Medical Affairs Study Director', 'oldOrganization': 'sanofi-aventis'}}}}