Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-02-23 @ 8:08 PM
Study NCT ID:
NCT02206659
Status:
COMPLETED
Last Update Posted:
2014-08-01
First Post:
2014-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Telmisartan by Ambulatory Blood Pressure Monitoring (ABPM) in Chinese Patients With Mild to Moderate Essential 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': 'D000077333', 'term': 'Telmisartan'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'lastUpdateSubmitDate': '2014-07-31', 'studyFirstSubmitDate': '2014-07-31', 'studyFirstSubmitQcDate': '2014-07-31', 'lastUpdatePostDateStruct': {'date': '2014-08-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2001-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean of trough/peak (T/P) ratio for diastolic blood pressure (DBP) and systolic blood pressure (SBP)', 'timeFrame': '42 days after start of treatment'}, {'measure': 'Median of T/P ratio for DBP and SBP', 'timeFrame': '42 days after start of treatment'}], 'secondaryOutcomes': [{'measure': 'Change in mean 24-hr DBP and SBP', 'timeFrame': 'Day -13, 42 days after start of treatment'}, {'measure': 'Change in daytime mean for SBP and DBP', 'timeFrame': 'Day -13, 42 days after start of treatment'}, {'measure': 'Change in nighttime mean for SBP and DBP', 'timeFrame': 'Day -13, 42 days after start of treatment'}, {'measure': 'Change in mean of DBP and SBP for last 6-hr dosing interval', 'timeFrame': 'Day -13, 42 days after start of treatment'}]}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'To assess the trough/peak ratio of 40 mg Telmisartan tablet by ambulatory blood pressure monitoring in Chinese patients with mild to moderate essential hypertension'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chinese male or female aged 18 to 75 years\n* Mild to moderate hypertension defined as a morning DBP \\_95 and \\<110 mm Hg at visit1 and visit 2. Mean sitting systolic pressure (SBP) must be \\<180 mm Hg\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Women who are pregnant or breast-feeding, or of childbearing potential without an effective method of birth control (effective birth control methods are: uterine device, surgical sterilisation, progestogens alone)\n* Known or suspected secondary hypertension\n* Known history of any chronic hepatic disease\n* Bilateral renal artery stenosis; renal artery stenosis in a solitary kidney; post-renal transplant\n* New York Heart Association (NYHA) functional class congestive heart failure (CHF) III-IV\n* Unstable angina pectoris\n* Myocardial infarction or percutaneous transluminal coronary angiography (PTCA) or cardiac surgery within the preceding three months\n* Clinical relevant cardiac arrhythmias as determined by the clinical investigator\n* Hypertrophic obstructive cardiomyopathy or clinically significant valvular disease\n* Evidence of retinal hemorrhages/exudates\n* Clinical significant hyperkalemia as defined by serum potassium level \\>6.0 milliequivalents (mEq)/L\n* Insulin-dependent diabetes mellitus\n* Non-insulin-dependent diabetes mellitus with poor glucose control as defined by persistent fasting blood sugar \\>200 mg/dl, peripheral neuropathy or autonomic neuropathy\n* Known drug or alcohol dependency\n* Administration of any diuretic, ACE inhibitor or angiotensin II receptor antagonist within two weeks before run-in period\n* Administration of medication known to affect blood pressure during trial period\n* Patients receiving any investigational therapy within one month of signing the informed consent form\n* Known hypersensitivity to any component of the formulation\n* Any other clinical condition which, in the opinion of the principal investigator, would not allow safe completion of the protocol and safe administration of trial medication'}, 'identificationModule': {'nctId': 'NCT02206659', 'briefTitle': 'Effects of Telmisartan by Ambulatory Blood Pressure Monitoring (ABPM) in Chinese Patients With Mild to Moderate Essential Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'An Open-label Evaluation of Trough and Peak Effects of 40 mg Telmisartan Tablet by Ambulatory Blood Pressure Monitoring in Chinese Patients With Mild to Moderate Essential Hypertension', 'orgStudyIdInfo': {'id': '502.367'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telmisartan', 'description': '2-week placebo run-in period followed by 6 weeks of treatment with telmisartan', 'interventionNames': ['Drug: Telmisartan', 'Drug: Placebo']}], 'interventions': [{'name': 'Telmisartan', 'type': 'DRUG', 'armGroupLabels': ['Telmisartan']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Telmisartan']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}