Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2026-03-04 @ 9:10 AM
Study NCT ID:
NCT02269228
Status:
COMPLETED
Last Update Posted:
2014-10-21
First Post:
2014-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tolerability of Asasantin in Healthy Female and Male Subjects
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': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'lastUpdateSubmitDate': '2014-10-20', 'studyFirstSubmitDate': '2014-10-20', 'studyFirstSubmitQcDate': '2014-10-20', 'lastUpdatePostDateStruct': {'date': '2014-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2000-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulated headache (intensity x duration) per day based on mean severity per waking hours expressed as area under the curve (AUC)', 'timeFrame': 'Day 14 after first drug administration'}], 'secondaryOutcomes': [{'measure': 'Proportion of subjects experiencing moderate/severe headache', 'timeFrame': 'Day 14 after first drug administration'}, {'measure': 'Proportion of subjects experiencing headache', 'timeFrame': 'Day 14 after first drug administration'}, {'measure': 'Cumulated headache (intensity x duration) per day based on maximum severity per day expressed as AUC', 'timeFrame': 'Day 14 after first drug administration'}, {'measure': 'Amount of acetylsalicylic acid (ASA) 500 used to cut headache', 'timeFrame': 'Day 14 after first drug administration'}, {'measure': 'Changes from baseline in vital signs', 'timeFrame': 'Pre-dose and day 17 after first drug administration'}, {'measure': 'Changes from baseline in laboratory tests', 'timeFrame': 'Pre-dose and day 17 after first drug administration'}, {'measure': 'Changes from baseline in 12-lead ECG', 'timeFrame': 'Pre-dose and day 17 after first drug administration'}, {'measure': 'Changes from baseline in physical examination', 'timeFrame': 'Pre-dose and day 17 after first drug administration'}, {'measure': 'Number of patients with adverse events', 'timeFrame': 'Up to day 17 after first drug administration'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'To investigate the occurrence of dipyridamole associated headaches in healthy subjects using a titration scheme or not'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All participants in the study should be healthy females/males, range from 18 to 55 years of age and be within a Broca Index of ≥ - 20 % and ≤ + 20 %\n* Prior to admission to the study all subjects will have given, in accordance with good clinical practice (GCP) and the local legislation, their written informed consent.\n\nExclusion Criteria:\n\n* Subjects will be excluded from the study if the results of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and are of clinical relevance\n* Subjects with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders\n* Subjects with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders or neurological disorders\n* Subjects with known history of orthostatic hypotension, fainting spells or blackouts\n* Subjects with chronic or relevant acute infections\n* Subjects with history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator\n* Subjects who have taken a drug with a long half-life (\\> 24 hours) (≤ 1 month prior to administration or during the trial)\n* Subjects who received any other drugs which might influence the results of the trial (≤ 10 days prior to administration or during the trial)\n* Subjects who have participated in another study with an investigational drug (≤ 1 month prior to administration or during the trial)\n* Subjects who smoke more than 15 cigarettes or 4 cigars or 4 pipes/day\n* Subjects who are not able to refrain from excessive consumption of methylxanthine containing drinks or food\n* Subjects who drink more than 60 g of alcohol per day\n* Subjects who are dependent on drugs\n* Subjects who have donated blood (\\> 400 ml) (≤ 4 weeks prior to administration or during the trial)\n* Subjects who have participated in excessive physical activities (≤ 5 days prior to administration or during the trial)\n\nFor female subjects:\n\n* Pregnancy\n* Positive pregnancy test\n* No adequate contraception (acceptable: e.g. sterilisation, intrauterine devices (IUD), oral contraceptives, condoms)\n* Inability to maintain this adequate contraception during the whole study period\n* Lactation period'}, 'identificationModule': {'nctId': 'NCT02269228', 'briefTitle': 'Tolerability of Asasantin in Healthy Female and Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Tolerability of a Two Week Treatment With Asasantin Extended Release 200/25 mg Capsules b.i.d., Compared to Reduced Dose During the First Week of Treatment in a Double-blind, Randomised, Placebo Controlled Parallel Group Comparison Trial in Healthy Female and Male Subjects', 'orgStudyIdInfo': {'id': '9.131'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Asasantin ER', 'description': 'Administered once daily (days 1 to 7), followed by twice daily administration (days 8 to 14)', 'interventionNames': ['Drug: Asasantin ER']}, {'type': 'EXPERIMENTAL', 'label': 'Asasantin ER, administered twice daily from day 1 to day 14', 'interventionNames': ['Drug: Asasantin ER']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Asasantin ER', 'type': 'DRUG', 'armGroupLabels': ['Asasantin ER', 'Asasantin ER, administered twice daily from day 1 to day 14']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}