Clinical trial NCT02269228: Tolerability of Asasantin in Healthy Female and Male Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the occurrence of dipyridamole associated headaches in healthy subjects using a titration scheme or not


Eligibility criteria: Inclusion Criteria:

* 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 %
* 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.

Exclusion Criteria:

* 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
* Subjects with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Subjects with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders or neurological disorders
* Subjects with known history of orthostatic hypotension, fainting spells or blackouts
* Subjects with chronic or relevant acute infections
* Subjects with history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Subjects who have taken a drug with a long half-life (\> 24 hours) (≤ 1 month prior to administration or during the trial)
* Subjects who received any other drugs which might influence the results of the trial (≤ 10 days prior to administration or during the trial)
* Subjects who have participated in another study with an investigational drug (≤ 1 month prior to administration or during the trial)
* Subjects who smoke more than 15 cigarettes or 4 cigars or 4 pipes/day
* Subjects who are not able to refrain from excessive consumption of methylxanthine containing drinks or food
* Subjects who drink more than 60 g of alcohol per day
* Subjects who are dependent on drugs
* Subjects who have donated blood (\> 400 ml) (≤ 4 weeks prior to administration or during the trial)
* Subjects who have participated in excessive physical activities (≤ 5 days prior to administration or during the trial)

For female subjects:

* Pregnancy
* Positive pregnancy test
* No adequate contraception (acceptable: e.g. sterilisation, intrauterine devices (IUD), oral contraceptives, condoms)
* Inability to maintain this adequate contraception during the whole study period
* Lactation period

Primary outcomes:
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
Secondary outcomes:
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
Other outcomes:
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