Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2026-06-21 @ 9:29 PM
Study NCT ID:
NCT01625494
Status:
COMPLETED
Last Update Posted:
2013-01-18
First Post:
2012-06-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Efficacy and Safety of Irbesartan/Amlodipine 4 Fixed Combination Therapy in Hypertensive Patients Uncontrolled on Irbesartan or Amlodipine Monotherapy
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'}, {'id': 'D017311', 'term': 'Amlodipine'}], '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'}, {'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 158}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-17', 'studyFirstSubmitDate': '2012-06-19', 'studyFirstSubmitQcDate': '2012-06-19', 'lastUpdatePostDateStruct': {'date': '2013-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with controlled OBPM (SBP<140 mmHg and DBP<90 mmHg) at the end of the study', 'timeFrame': 'up to 16 weeks'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with controlled OBPM by visit and treatment group', 'timeFrame': 'up to 16 weeks', 'description': 'at Visit 3 (Week 8), at Visit 4 (Week 12) and at Visit 5 (Week 16)'}, {'measure': 'Mean change in OBPM between 2 visits', 'timeFrame': 'up to 16 weeks', 'description': 'Visit 2 (Week 4) and Visit 5 (Week 16), Visit 2 (Week 4) and Visit 4 (week 12), Visit 2 (Week 4) and Visit 5 (Week 16), Visit 3 (Week 8) and Visit 4 (Week 12), Visit 3 (Week 8) and Visit 5 (Week 16)'}, {'measure': 'Number of patients with adverse events', 'timeFrame': 'up to 16 weeks'}, {'measure': 'Number of patients who discontinue from the study due to adverse events', 'timeFrame': 'up to 16 weeks'}, {'measure': 'Number of patients with abnormal liver function', 'timeFrame': 'up to 16 weeks', 'description': 'As measured by AST, ALT, total bilirubin and serum creatinine'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\n\\- To assess the proportion of patients with controlled Office Blood Pressure Measurements (OBPM), defined as Systolic blood pressure \\< 140 mmHg and Diastolic blood pressure \\<90mmHg, at the end of the study\n\nSecondary Objectives:\n\n* To examine over time the antihypertensive effect of the 4 doses of the fixed combination therapy irbesartan/amlodipine on OBPM (SBP (systolic blood pressure) and DBP (diastolic blood pressure)\n* To examine the proportion of patients with controlled OBPM (systolic BP\\<140 mm Hg and diastolic BP\\<90 mmHg) of the different dose groups over time\n* To determine the incidence and severity of adverse events.', 'detailedDescription': '16 weeks\n\n* V1 (week 0): Inclusion visit.\n* V2 (Week 4): Irbesartan/amlodipine 150/5 mg fixed combination visit\n* V3 (Week 8): 1st dose escalation for patients in whom OBPM is not controlled (SBP ≥ 140 mmHg or DBP ≥ 90mmHg,\n* V4 (Week 12): 2nd Dose escalation visit for patients in whom OBPM is not controlled (SBP ≥ 140 mmHg or DBP ≥ 90mmHg\n* V5 (Week 16): End of study visit'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria :\n\n* Men and women ≥18 years old\n* Established essential hypertension\n* Treated with irbesartan 150 mg or amlodipine 5 mg as monotherapy for at least 2 weeks\n* With uncontrolled systolic BP (blood pressure) defined as ≥140 mm Hg assessed by OBPM (office blood pressure measurements)\n* Signed written informed consent obtained prior to inclusion to the study\n\nExclusion criteria:\n\n* Mean systolic BP ≥180 mm Hg and/or mean diastolic BP ≥110 mm Hg by OBPM on Visit 1\n* Known or suspected causes of secondary hypertension\n* Patients with bilateral artery stenosis, renal artery stenosis in a solitary kidney, renal transplant or only has one functioning kidney\n* Known contraindications or hypersensitivity to either amlodipine or irbesartan or to the combination\n* History of angioedema related to the administration of an angiotensin II receptor antagonist or any combination of the drugs used\n* Severe hepatic impairment (Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) \\>5 times the upper normal limit (ULN) or history of hepatic encephalopathy, esophageal varices or portocaval shunt)\n* Severe renal impairment (glomerular filtration rate \\<30 ml/min)\n* Concomitant use of any other antihypertensive treatment except of Irbesartan and Amlodipine\n* Administration of any other investigational drug within 30 days before inclusion\n* Presence of any other conditions that would restrict or limit the patient participation for the duration of the study\n* Pregnant or breast feeding women\n* Women of childbearing potential unable or unwilling to use an acceptable method to avoid pregnancy for the entire study period\n* Patient is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT01625494', 'briefTitle': 'Study of Efficacy and Safety of Irbesartan/Amlodipine 4 Fixed Combination Therapy in Hypertensive Patients Uncontrolled on Irbesartan or Amlodipine Monotherapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Prospective Open-label Multicentre Study of Efficacy and Safety of Irbesartan/Amlodipine 4 Fixed Combination Therapy in Hypertensive Patients Uncontrolled on Irbesartan 150 mg or Amlodipine 5 mg Monotherapy', 'orgStudyIdInfo': {'id': 'IRBES_L_05887'}, 'secondaryIdInfos': [{'id': 'U1111-1117-9116', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Irbesartan/Amlodipine 150/5 mg fixed combination', 'description': '1 tablet once daily in the morning for 4 weeks Patient will be first treated with irbesartan 150mg or amlodipine 5mg, 1 tablet /day for 4 weeks.\n\nIf OBPM is controlled on monotherapy at week 4 (SBP \\<140 mmHg and DBP\\<90 mmHg), patient will be withdrawn from the study', 'interventionNames': ['Drug: Irbesartan/Amlodipine (150/5mg)']}, {'type': 'EXPERIMENTAL', 'label': 'Irbesartan/Amlodipine 150/10 mg fixed combination', 'description': '1 tablet once daily in the morning for 4 weeks', 'interventionNames': ['Drug: Irbesartan/Amlodipine (150/10mg)']}, {'type': 'EXPERIMENTAL', 'label': 'Irbesartan/Amlodipine 300/5 mg fixed combination', 'description': '1 tablet once daily in the morning for 4 weeks', 'interventionNames': ['Drug: Irbesartan/Amlodipine (300/5mg)']}, {'type': 'EXPERIMENTAL', 'label': 'Irbesartan/Amlodipine 300/10 mg fixed combination', 'description': '1 tablet once daily in the morning for 4 weeks. If OBPM is controlled at week 12, patients will continue on the same therapy until the end of the study', 'interventionNames': ['Drug: Irbesartan/Amlodipine (300/10mg)']}], 'interventions': [{'name': 'Irbesartan/Amlodipine (150/5mg)', 'type': 'DRUG', 'description': 'Pharmaceutical form: tablet Route of administration: oral', 'armGroupLabels': ['Irbesartan/Amlodipine 150/5 mg fixed combination']}, {'name': 'Irbesartan/Amlodipine (150/10mg)', 'type': 'DRUG', 'description': 'Pharmaceutical form: tablet Route of administration: oral', 'armGroupLabels': ['Irbesartan/Amlodipine 150/10 mg fixed combination']}, {'name': 'Irbesartan/Amlodipine (300/5mg)', 'type': 'DRUG', 'description': 'Pharmaceutical form: tablet Route of administration: oral', 'armGroupLabels': ['Irbesartan/Amlodipine 300/5 mg fixed combination']}, {'name': 'Irbesartan/Amlodipine (300/10mg)', 'type': 'DRUG', 'description': 'Pharmaceutical form:tablet Route of administration: oral', 'armGroupLabels': ['Irbesartan/Amlodipine 300/10 mg fixed combination']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Moscow', 'country': 'Russia', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}