Completed

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

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What is being tested

Asasantin ER

+ Placebo

Drug
Who is being recruted

From 18 to 55 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 1
Interventional
Study Start: February 2000
See protocol details

Summary

Principal SponsorBoehringer Ingelheim
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2000

Actual date on which the first participant was enrolled.

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

Official TitleTolerability 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
Principal SponsorBoehringer Ingelheim
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Administered once daily (days 1 to 7), followed by twice daily administration (days 8 to 14)

Group II

Experimental

Group III

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers