Ignite Creation Date:
2025-12-25 @ 2:33 AM
Ignite Modification Date:
2025-12-30 @ 10:58 AM
Study NCT ID:
NCT01392534
Status:
COMPLETED
Last Update Posted:
2012-07-04
First Post:
2011-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Telmisartan/Hydrochlorothiazide Treatment in Hypertensive Patients Under Real-life Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000075222', 'term': 'Essential Hypertension'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077333', 'term': 'Telmisartan'}, {'id': 'D006852', 'term': 'Hydrochlorothiazide'}], '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': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002740', 'term': 'Chlorothiazide'}, {'id': 'D001581', 'term': 'Benzothiadiazines'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D049971', 'term': 'Thiazides'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1586}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-03', 'studyFirstSubmitDate': '2011-05-26', 'studyFirstSubmitQcDate': '2011-07-11', 'lastUpdatePostDateStruct': {'date': '2012-07-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in systolic (SBP) and diastolic (DBP) blood pressure between first and final visit', 'timeFrame': 'approx. 3 mths after telmisartan/hydrochlorothiazide treatment initiation'}], 'secondaryOutcomes': [{'measure': 'Change in plasma potassium between initial and final visit', 'timeFrame': 'approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation'}, {'measure': 'Change in fasting plasma glucose between initial and final visit', 'timeFrame': 'approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation'}, {'measure': 'Change in glycated haemoglobin A1C between initial and final visit', 'timeFrame': 'approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation'}, {'measure': 'Change in plasma high density lipoprotein between initial and (continued)', 'timeFrame': 'approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation'}, {'measure': 'Change in plasma low density lipoprotein between initial and final visit', 'timeFrame': 'approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation'}, {'measure': 'Change in plasma cholesterol between initial and final visit', 'timeFrame': 'approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation'}, {'measure': 'Change in plasma triglycerides between initial and final visit', 'timeFrame': 'approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation'}, {'measure': 'Adverse events collection', 'timeFrame': 'approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypertension', 'Telmisartan', 'Hydrochlorothiazide', 'Potassium', 'Glucose metabolism', 'Lipid metabolism'], 'conditions': ['Primary Hypertension']}, 'descriptionModule': {'briefSummary': 'One of the most common adverse effects resulting from the therapy with thiazides, thiazide-like diuretics and loop diuretics is increased potassium secretion. Disregulation of plasma potassium may be a life-threatening condition due to increased risk of arrythmias. Moreover, it has been postulated that decrease in plasma potassium level may negatively affect glucose metabolism resulting in the increased risk of new-onset type 2 diabetes.The main goal of this study is to assess the efficacy and safety of telmisartan/hydrochlorothiazide in a broad population of hypertensive patients, including the effects of the therapy on plasma potassium level and also on selected parameters of glucose and lipid metabolism.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care clinic hypertensive patients not treated with telmisartan/hydrochlorothiazide for approx. 3 mths.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primary hypertension\n* age\\>18 years\n\nExclusion Criteria:\n\n* Cholestatic disorders or severe hepatic/renal failure\n* allergy to telmisartan or hydrochlorothiazide\n* treatment-resistant hypokalemia or hypercalcemia\n* pregnancy and lactation period'}, 'identificationModule': {'nctId': 'NCT01392534', 'acronym': 'POTASSIUM', 'briefTitle': 'Effects of Telmisartan/Hydrochlorothiazide Treatment in Hypertensive Patients Under Real-life Setting', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Evaluation of the Real-life Efficacy and Safety of a Fixed-dose Telmisartan/Hydrochlorothiazide, Including Its Effect on Plasma Potassium and on Glucose and Lipid Metabolism Parameters in Patients With Essential Arterial Hypertension', 'orgStudyIdInfo': {'id': '15297'}, 'secondaryIdInfos': [{'id': 'KL1010PL', 'type': 'OTHER', 'domain': 'Company Internal'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'interventionNames': ['Drug: Telmisartan/hydrochlorothiazide (Pritor Plus, BAY98-7103)']}], 'interventions': [{'name': 'Telmisartan/hydrochlorothiazide (Pritor Plus, BAY98-7103)', 'type': 'DRUG', 'description': 'Patients treated with telmisartan/hydrochlorothiazide tablets under the real-life setting. Dosing regimen customised to the needs of each participating patient according to the investigators assessment', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Many Locations', 'country': 'Poland'}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Medical Director', 'oldOrganization': 'Bayer Sp. z o.o. , Poland'}}}}