HealthyPhase 1NCT02269228
Tolerability of Asasantin in Healthy Female and Male Subjects
A Phase 1 study testing Asasantin ER in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To investigate the occurrence of dipyridamole associated headaches in healthy subjects using a titration scheme or not Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Asasantin ER
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Feb 2000to Apr 2000
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 21Show fewer
- 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
About this study
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
To investigate the occurrence of dipyridamole associated headaches in healthy subjects using a titration scheme or not
- Conditions
- Healthy
- Being tested
- Asasantin ER, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asasantin ERDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Asasantin ER | Experimental | Administered once daily (days 1 to 7), followed by twice daily administration (days 8 to 14) Receives: Drug: Asasantin ER |
| Asasantin ER, administered twice daily from day 1 to day 14 | Experimental | Not described Receives: Drug: Asasantin ER |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulated headache (intensity x duration) per day based on mean severity per waking hours expressed as area under the curve (AUC)
Measured: Day 14 after first drug administration
Secondary outcomes (9)
Proportion of subjects experiencing moderate/severe headache
Measured: Day 14 after first drug administration
Proportion of subjects experiencing headache
Measured: Day 14 after first drug administration
Cumulated headache (intensity x duration) per day based on maximum severity per day expressed as AUC
Measured: Day 14 after first drug administration
Amount of acetylsalicylic acid (ASA) 500 used to cut headache
Measured: Day 14 after first drug administration
Changes from baseline in vital signs
Measured: Pre-dose and day 17 after first drug administration
Changes from baseline in laboratory tests
Measured: Pre-dose and day 17 after first drug administration
Changes from baseline in 12-lead ECG
Measured: Pre-dose and day 17 after first drug administration
Changes from baseline in physical examination
Measured: Pre-dose and day 17 after first drug administration
Number of patients with adverse events
Measured: Up to day 17 after first drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startFeb 2000
- Primary completionApr 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02269228
- Sponsor's protocol ID
- 9.131
- Status last verified
- Oct 2014
- First submitted
- 20 Oct 2014
- Last updated
- 21 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02269228
- Acronym / sponsor ID
- 9.131
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Feb 2000
- Primary completion
- Apr 2000 (actual)
- First posted
- 21 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the occurrence of dipyridamole associated headaches in healthy subjects using a titration scheme or not
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Asasantin ER | Experimental | Drug: Asasantin ERAdministered once daily (days 1 to 7), followed by twice daily administration (days 8 to 14) |
| Asasantin ER, administered twice daily from day 1 to day 14 | Experimental | Drug: Asasantin ER |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Asasantin ER | Drug | Asasantin ER, Asasantin ER, administered twice daily from day 1 to day 14 |
| Placebo | Drug | Placebo |
Primary outcome
Cumulated headache (intensity x duration) per day based on mean severity per waking hours expressed as area under the curve (AUC)
Time frame: Day 14 after first drug administration
9 secondary outcomes
Proportion of subjects experiencing moderate/severe headache
Time frame: Day 14 after first drug administration
Proportion of subjects experiencing headache
Time frame: Day 14 after first drug administration
Cumulated headache (intensity x duration) per day based on maximum severity per day expressed as AUC
Time frame: Day 14 after first drug administration
Amount of acetylsalicylic acid (ASA) 500 used to cut headache
Time frame: Day 14 after first drug administration
Changes from baseline in vital signs
Time frame: Pre-dose and day 17 after first drug administration
Changes from baseline in laboratory tests
Time frame: Pre-dose and day 17 after first drug administration
Changes from baseline in 12-lead ECG
Time frame: Pre-dose and day 17 after first drug administration
Changes from baseline in physical examination
Time frame: Pre-dose and day 17 after first drug administration
Number of patients with adverse events
Time frame: Up to day 17 after first drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2014.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Asasantin ER in people with Healthy, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulated headache (intensity x duration) per day based on mean severity per waking hours expressed as area under the curve (AUC) (time frame: Day 14 after first drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2014.