Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2026-02-20 @ 6:48 PM
Study NCT ID:
NCT00819104
Status:
COMPLETED
Last Update Posted:
2009-09-09
First Post:
2009-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Compare the Efficacy, Safety and Tolerability of Selomax With Its Individual Components
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000075222', 'term': 'Essential Hypertension'}], 'ancestors': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017311', 'term': 'Amlodipine'}], 'ancestors': [{'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 402}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-07', 'studyFirstSubmitDate': '2009-01-07', 'studyFirstSubmitQcDate': '2009-01-07', 'lastUpdatePostDateStruct': {'date': '2009-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in BP with Selomax™ 50/5 at the end of the randomisation treatment period.', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in BP (SBP,DBP & mean BP) with SelomaxTM 25/2.5 at the end of the randomisation period.', 'timeFrame': '8 weeks'}, {'measure': 'Change in the heart rate,Number of responders & control rates.', 'timeFrame': '8 weeks'}, {'measure': 'Incidence of adverse events (serious and non-serious) in each arm.Change in hemogram, serum chemistry (Liver function tests (LFT), Renal function tests (RFT), plasma lipids, Blood Glucose, HbA1c), and Ur.albumin', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Primary hypertension', 'Metoprolol XL', 'Amlodipine'], 'conditions': ['Primary Hypertension']}, 'descriptionModule': {'briefSummary': 'This is a randomised, open-label; parallel group, multicentric study comparing the efficacy and safety of fixed-dose-combinations of Metoprolol XL plus Amlodipine with individual components of the combination. SelomaxTM50/5 will also be compared with SelomaxTM 25/2.5 in lowering of BP (SBP and DBP) in Indian patients with essential hypertension.Male and female patients of essential hypertension aged between 18-80 years will be studied. The patients should not have a history of prior cardiovascular disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of hypertension (primary) , as judged by 2 BP measurements before randomisation\n* Those who have given their written consent for the study.\n\nExclusion Criteria:\n\n* Patients of other forms of hypertension (other than primary)\n* Those who have consistently BP \\> /=180/120mmHg\n* Patients with a prior history of chest pain, heart attacks, conduction defects and strokes.\n* Patients of diabetes requiring insulin,asthma and kidney diseases.'}, 'identificationModule': {'nctId': 'NCT00819104', 'acronym': 'MARS', 'briefTitle': 'A Study to Compare the Efficacy, Safety and Tolerability of Selomax With Its Individual Components', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Five-arm, Randomised, Open Label, Multi-centre, Prospective Study to Compare the Efficacy, Safety and Tolerability of Metoprolol XL Plus Amlodipine Combination (Selomax TM) With Metoprolol XL and Amlodipine as Individual Components in Management of Hypertension in Indian Patients.', 'orgStudyIdInfo': {'id': 'D4022L00006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'FDC of Metoprolol XL 50mg + Amlodipine 5mg', 'interventionNames': ['Drug: Metoprolol XL 50mg + Amlodipine 5mg']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'FDC of Metoprolol XL 25mg + Amlodipine 2.5mg', 'interventionNames': ['Drug: Metoprolol XL 25 mg + Amlodipine 2.5mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'Extended release Metoprolol succinate', 'interventionNames': ['Drug: Metoprolol XL 50mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4', 'description': 'Extended release Metoprolol succinate', 'interventionNames': ['Drug: Metoprolol XL 25 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': '5', 'description': 'Amlodipine 5mg in immediate release formulation', 'interventionNames': ['Drug: Amlodipine 5mg']}], 'interventions': [{'name': 'Metoprolol XL 50mg + Amlodipine 5mg', 'type': 'DRUG', 'otherNames': ['Selomax 50/5'], 'description': 'tablet,oral,OD,8 weeks', 'armGroupLabels': ['1']}, {'name': 'Metoprolol XL 25 mg + Amlodipine 2.5mg', 'type': 'DRUG', 'otherNames': ['Selomax 25/2.5'], 'description': 'tablet,oral,OD,8 weeks', 'armGroupLabels': ['2']}, {'name': 'Metoprolol XL 50mg', 'type': 'DRUG', 'otherNames': ['Revelol XL'], 'description': 'tablet,oral,OD,8 weeks', 'armGroupLabels': ['3']}, {'name': 'Metoprolol XL 25 mg', 'type': 'DRUG', 'otherNames': ['Revelol XL'], 'description': 'tablet,oral,OD,8 weeks', 'armGroupLabels': ['4']}, {'name': 'Amlodipine 5mg', 'type': 'DRUG', 'otherNames': ['Amlogard'], 'description': 'tablet,oral,OD,8 weeks', 'armGroupLabels': ['5']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hyderabad', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'Research Site'}, {'city': 'Ahmedabad', 'state': 'Gujarat', 'country': 'India', 'facility': 'Research Site', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Research Site', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'city': 'Calicut', 'state': 'Kerala', 'country': 'India', 'facility': 'Research Site', 'geoPoint': {'lat': 11.24802, 'lon': 75.7804}}, {'city': 'Mumbai', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Research Site', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'city': 'Pune', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Research Site', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'city': 'Delhi', 'state': 'National Capital Territory of Delhi', 'country': 'India', 'facility': 'Research Site', 'geoPoint': {'lat': 28.65195, 'lon': 77.23149}}, {'city': 'Jaipur', 'state': 'Rajasthan', 'country': 'India', 'facility': 'Research Site', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'city': 'Lucknow', 'state': 'Uttar Pradesh', 'country': 'India', 'facility': 'Research Site', 'geoPoint': {'lat': 26.83928, 'lon': 80.92313}}, {'city': 'Kolkata', 'state': 'West Bengal', 'country': 'India', 'facility': 'Research Site', 'geoPoint': {'lat': 22.56263, 'lon': 88.36304}}, {'city': 'Bangalore', 'country': 'India', 'facility': 'Research Site', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'collaborators': [{'name': "St. John's Research Institute", 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Dr. Paurus M Irani; VP Medical & Regulatory', 'oldOrganization': 'AstraZeneca Pharmaceuticals India Ltd.'}}}}