Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2026-02-24 @ 1:16 AM
Study NCT ID:
NCT02264158
Status:
COMPLETED
Last Update Posted:
2014-10-15
First Post:
2014-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Telmisartan and Lacidipine, Combined or Alone, on QT Interval in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 149}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'lastUpdateSubmitDate': '2014-10-14', 'studyFirstSubmitDate': '2014-10-14', 'studyFirstSubmitQcDate': '2014-10-14', 'lastUpdatePostDateStruct': {'date': '2014-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average QTcF (QT interval Fridericia correction) change', 'timeFrame': 'baseline, day 1, day 7'}], 'secondaryOutcomes': [{'measure': 'Change in QT interval', 'timeFrame': 'baseline, day 1, day 7'}, {'measure': 'Change in QTcB (QT interval Bazett correction) interval', 'timeFrame': 'baseline, day 1, day 7'}, {'measure': 'Change in PQ interval', 'timeFrame': 'baseline, day 1, day 7'}, {'measure': 'Change in QRS interval', 'timeFrame': 'baseline, day 1, day 7'}, {'measure': 'Change in RR interval', 'timeFrame': 'baseline, day 1, day 7'}, {'measure': 'Change in heart rate (HR)', 'timeFrame': 'baseline, day 1, day 7'}, {'measure': 'Occurrence of ECG abnormalities', 'timeFrame': 'baseline, day 1, day 7'}, {'measure': 'Change in T wave morphology', 'timeFrame': 'baseline, day 1, day 7', 'description': 'normal, flat, inverted, biphasic'}, {'measure': 'Change in U wave morphology', 'timeFrame': 'baseline, day 1, day 7', 'description': 'normal, abnormal'}, {'measure': 'Area under the plasma concentration time curve (AUC)', 'timeFrame': 'day 1, day 7'}, {'measure': 'Maximum plasma concentration (Cmax)', 'timeFrame': 'day 1, day 7'}, {'measure': 'Time to attain maximum plasma concentration (tmax)', 'timeFrame': 'day 1, day 7'}, {'measure': 'Trough plasma concentration at steady state (Cmin,ss)', 'timeFrame': 'day 7'}, {'measure': 'Number of participants with adverse events', 'timeFrame': 'up to 8 days after last treatment'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Assessment of the influence of telmisartan, lacidipine and their combination on the QTC interval of the ECG'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll participants in the study should be healthy males/females, range from 21 to 50 years of age and their body mass index (BMI) be within 18.5 to 29.9 kg/m2.\n\nIn accordance with Good Clinical Practice and local legislation all volunteers will have given their written informed consent prior to admission to the study.\n\nExclusion Criteria:\n\n* Any finding of the medical examination (including blood pressure, heart rate and ECG) deviating from normal and of clinical relevance\n* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders\n* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders\n* History of orthostatic hypotension, fainting spells or blackouts\n* Chronic or relevant acute infections\n* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator\n* Intake of drugs with a long half-life (\\>24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study\n* Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study\n* Participation in another tiral with an investigational drug (\\<= two months prior to administration or during the trial)\n* Smoker (\\> 10 cigarettes or \\> 3 cigars or \\> 3 pipes/day)\n* Inability to refrain from smoking on trial days\n* Alcohol abuse (\\> 60 g/day)\n* Drug abuse\n* Blood donation (\\>= 100 ml within four weeks prior to administration or during the trial)\n* Any laboratory value outside the clinically accepted reference range\n* Excessive physical activities within the last week before the trial or during the trial\n\nFollowing exclusion criteria are of special interest for this study:\n\n* Hypersensitivity to telmisartan, lacidipine and/or related drugs of these classes\n* Supine blood pressure at screening of systolic \\<= 110 mmHg and diastolic \\<= 60 mmHg\n* Any ECG value outside of the reference range of clinical relevance, but not limited to PR interval \\> 240 ms, QRS interval \\> 110 ms, QTcB \\> 470 ms for females and QTcB \\> 450 ms for males\n\nFor female subjects:\n\n* Pregnancy\n* Positive pregnancy test\n* No adequate contraception (adequate contraception e.g. sterilisation, intrauterine pessary (IUP), oral contraceptives)\n* Inability to maintain this adequate contraception during the whole study period\n* Lactation period'}, 'identificationModule': {'nctId': 'NCT02264158', 'briefTitle': 'Influence of Telmisartan and Lacidipine, Combined or Alone, on QT Interval in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Double-blind, Randomised, Placebo Controlled, 6 Parallel Groups Study to Assess the Influence of Telmisartan (40 mg or 160 mg), Lacidipine (4 mg or 6 mg) and Their Combination (Telmisartan 40 mg and Lacidipine 4 mg) p.o. Once Daily for Seven Days on the QT Interval of the ECG in Healthy Male and Female Volunteers', 'orgStudyIdInfo': {'id': '502.378'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telmisartan high', 'interventionNames': ['Drug: Telmisartan high']}, {'type': 'EXPERIMENTAL', 'label': 'Telmisartan low', 'interventionNames': ['Drug: Telmisartan low']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lacidipine high', 'interventionNames': ['Drug: Lacidipine high']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lacidipine low', 'interventionNames': ['Drug: Lacidipine low']}, {'type': 'EXPERIMENTAL', 'label': 'Telmisartan+Lacidipine', 'interventionNames': ['Drug: Telmisartan low', 'Drug: Lacidipine low']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Telmisartan high', 'type': 'DRUG', 'armGroupLabels': ['Telmisartan high']}, {'name': 'Telmisartan low', 'type': 'DRUG', 'armGroupLabels': ['Telmisartan low', 'Telmisartan+Lacidipine']}, {'name': 'Lacidipine high', 'type': 'DRUG', 'armGroupLabels': ['Lacidipine high']}, {'name': 'Lacidipine low', 'type': 'DRUG', 'armGroupLabels': ['Lacidipine low', 'Telmisartan+Lacidipine']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}