Tolerability of Asasantin in Healthy Female and Male Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Asasantin ER; Drug: Placebo

• Registration Number: NCT02269228
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2000-02
• Primary Completion: 2000-04
• Status Verified: 2014-10
• Study First Submitted: 2014-10-20
• Study First Submitted QC: 2014-10-20
• Last Update Submitted: 2014-10-20
• Study First Posted: 2014-10-21
• Last Update Posted: 2014-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Asasantin ER, administered twice daily from day 1 to day 14	Asasantin ER	-
Asasantin ER	Asasantin ER	Administered once daily (days 1 to 7), followed by twice daily administration (days 8 to 14)
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Cumulated headache (intensity x duration) per day based on mean severity per waking hours expressed as area under the curve (AUC)	Day 14 after first drug administration

Secondary Outcome Measures

Name	Time	Method
Cumulated headache (intensity x duration) per day based on maximum severity per day expressed as AUC	Day 14 after first drug administration
Amount of acetylsalicylic acid (ASA) 500 used to cut headache	Day 14 after first drug administration
Changes from baseline in laboratory tests	Pre-dose and day 17 after first drug administration
Changes from baseline in 12-lead ECG	Pre-dose and day 17 after first drug administration
Proportion of subjects experiencing moderate/severe headache	Day 14 after first drug administration
Proportion of subjects experiencing headache	Day 14 after first drug administration
Changes from baseline in vital signs	Pre-dose and day 17 after first drug administration
Changes from baseline in physical examination	Pre-dose and day 17 after first drug administration
Number of patients with adverse events	Up to day 17 after first drug administration