Tolerability of Asasantin in Healthy Female and Male Subjects

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: Asasantin ER

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Experimental: Asasantin ER; Administered once daily (days 1 to 7), followed by twice daily administration (days 8 to 14)	Drug: Asasantin ER
Experimental: Asasantin ER, administered twice daily from day 1 to day 14	Drug: Asasantin ER

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Proportion of subjects experiencing moderate/severe headache	Day 14 after first drug administration
Proportion of subjects experiencing headache	Day 14 after first drug administration
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 vital signs	Pre-dose and day 17 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
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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: February 1, 2000
• Primary Completion (Actual): April 1, 2000

Study Registration Dates

• First Submitted: October 20, 2014
• First Submitted That Met QC Criteria: October 20, 2014
• First Posted (Estimate): October 21, 2014

Study Record Updates

• Last Update Posted (Estimate): October 21, 2014
• Last Update Submitted That Met QC Criteria: October 20, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Platelet Aggregation Inhibitors; Aspirin, Dipyridamole Drug Combination
• Other Study ID Numbers: 9.131