Cerebrovascular AccidentPhase 3NCT00274586
Headache Study to Compare Aggrenox Full Dose and Reduced Dose
A Phase 3 study testing Aggrenox® modified release capsules in people with Cerebrovascular Accident, run by Boehringer Ingelheim at 1 site in Taiwan.
Trial summary
Tolerability of a four weeks treatment with Aggrenox® modified release capsules b.i.d, compared to reduced dose during the first two weeks of treatment in a double-blind, randomized controlled parallel group comparison trial among Taiwanese patients with previous TIA's or ischemic stroke.To monitor frequency and… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- Aggrenox® modified release capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2002to Apr 2003
- Phase
- Phase 3
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20 years old or above.
- History of TIA or completed ischemic stroke
- Signed informed consent.
- Patient with score < 2 on modified Rankin's Classification of Neurological Status.
Who cannot join
- Patients with known or suspected prior intracranial haemorrhage or history of brain injury or brain tumor.
- Disorders related to syncope, drop attacks, congenital vascular malformation, aneurysm, angioma, or epilepsy, psychiatric disorders.
- Peptic ulcer or gastrointestinal bleeding within 6 months.
- History of hypersensitivity or intolerance to study drugs or aspirin.
- Experienced habitual headache (any form) within the past 3 months.
- History of dysphasia, dysphagia, dementia, or unconsciousness.
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- Patients currently taking other medications known to cause headaches (e.g., nitrates).
- Patients with deteriorating angina, subvalvular aortic stenosis or hemodynamic liability (e.g., in conjunction with a recent myocardial infarction).
- Uncontrolled hypertension (SBP > 220 mmHg, DBP> 120 mmHg) or life-threatening disease.
- Any significant disorders, such as chronic renal failure (serum creatinine > 2.0 mg/dl), neoplasia.
- SGPT, SGOT value greater than 2 times of the upper normal limit.
- Insulin dependent diabetes mellitus or poorly controlled non-insulin dependent diabetes mellitus (AC sugar > 300 mg/dl).
- Use of other anticoagulants, such as anti-coagulated agents or NSAIDsS.
- History of alcohol and/or drug abuse.
- Having participated in other investigational drug study within 3 months prior to study entry.
- Pregnant or lactating women or women of childbearing potential whom are not practicing reliable birth control.
- The patients who take methylxanthine-containing drinks or foods (coffee, black tea, cola, energy drink, etc.) more than 4 cups of coffee or it's equivalents.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tolerability of a Four Weeks Treatment With Aggrenox® Modified Release Capsules b.i.d, Compared to Reduced Dose During the First Two Weeks of Treatment in a Double-Blind, Randomized Controlled Parallel Group Comparison Trial Among Taiwanese Patients With Previous TIAs or Ischemic Stroke
Tolerability of a four weeks treatment with Aggrenox® modified release capsules b.i.d, compared to reduced dose during the first two weeks of treatment in a double-blind, randomized controlled parallel group comparison trial among Taiwanese patients with previous TIA's or ischemic stroke.To monitor frequency and intensity of headaches and other safety parameters among Taiwanese patients with previous TIA's or ischemic stroke given Aggrenox using a titration scheme or not
Read the detailed description
The major objective of the study is to evaluate the tolerance of headache and safety in Taiwan Taiwanese patients who are receiving two different dosing regimens of Aggrenox and Aggrenox placebo. The first group will start with placebo on days 1-4, daily dose on days 5-14, and following by b.i.d treatment on 15-28 days. This group will also receive a matching placebo in the morning and one Aggrenox capsule in the evening before on days 5-14. It enables to reduce the perception of dipyridamole-associated headache. The second group will receive the placebo twice daily on days 1-4, and medication twice daily for the remaining course. The third group will receive the placebo twice daily for the whole course.
Study Hypothesis:
NULL AND ALTERNATIVE HYPOTHESES
From a subject diary, asking for the most frequent side effects observed in the ESPS2 trial, the cumulative headache (intensity x frequency) per day based on the first three days of treatment period defines the primary endpoint.
I: H0: Median cumulative headache is equal for all treatment groups vs. HA: Median cumulative headache is not equal for all treatment groups
II: H0: Median cumulative headache of low dose regimen?Median cumulative headache of regular dose vs. HA: Median cumulative headache of low dose regimen < Median cumulative headache of regular dose
Comparison(s):
Compare Aggrenox full dose, reduced dose and placebo
- Conditions
- Cerebrovascular Accident
- Being tested
- Aggrenox® modified release capsules, Aggrenox® modified release capsules matching placebo
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aggrenox® modified release capsulesDrug
Aggrenox® modified release capsules matching placeboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulated headache (intensity x frequency) over the first three days of treatment period
Secondary outcomes (1)
Proportion of (1) subjects drop out due to drug related AE and (2) experiencing grade 3 or 4 drug related headache during day 5-14, day 15-21 (reduced dose), day 5-11 (regular dose), day 7, day 28; as well as (3) Number of acetaminophen tablets used.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2006 (estimated)
- Study startSep 2002
- Primary completionApr 2003
- Study completionApr 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular AccidentStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, B.I. Taiwan Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00274586
- Sponsor's protocol ID
- 9.155
- Status last verified
- Oct 2013
- First submitted
- 10 Jan 2006
- Last updated
- 31 Oct 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerability of a Four Weeks Treatment With Aggrenox® Modified Release Capsules b.i.d, Compared to Reduced Dose During the First Two Weeks of Treatment in a Double-Blind, Randomized Controlled Parallel Group Comparison Trial Among Taiwanese Patients With Previous TIAs or Ischemic Stroke
- ClinicalTrials.gov ID
- NCT00274586
- Acronym / sponsor ID
- 9.155
- Conditions
- Cerebrovascular Accident
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Sep 2002
- Primary completion
- Apr 2003 (actual)
- Study completion
- Apr 2003
- First posted
- 11 Jan 2006 (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.
Tolerability of a four weeks treatment with Aggrenox® modified release capsules b.i.d, compared to reduced dose during the first two weeks of treatment in a double-blind, randomized controlled parallel group comparison trial among Taiwanese patients with previous TIA's or ischemic stroke.To monitor frequency and intensity of headaches and other safety parameters among Taiwanese patients with previous TIA's or ischemic stroke given Aggrenox using a titration scheme or not
Detailed description
The major objective of the study is to evaluate the tolerance of headache and safety in Taiwan Taiwanese patients who are receiving two different dosing regimens of Aggrenox and Aggrenox placebo. The first group will start with placebo on days 1-4, daily dose on days 5-14, and following by b.i.d treatment on 15-28 days. This group will also receive a matching placebo in the morning and one Aggrenox capsule in the evening before on days 5-14. It enables to reduce the perception of dipyridamole-associated headache. The second group will receive the placebo twice daily on days 1-4, and medication twice daily for the remaining course. The third group will receive the placebo twice daily for the whole course.
Study Hypothesis:
NULL AND ALTERNATIVE HYPOTHESES
From a subject diary, asking for the most frequent side effects observed in the ESPS2 trial, the cumulative headache (intensity x frequency) per day based on the first three days of treatment period defines the primary endpoint.
I: H0: Median cumulative headache is equal for all treatment groups vs. HA: Median cumulative headache is not equal for all treatment groups
II: H0: Median cumulative headache of low dose regimen?Median cumulative headache of regular dose vs. HA: Median cumulative headache of low dose regimen < Median cumulative headache of regular dose
Comparison(s):
Compare Aggrenox full dose, reduced dose and placebo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 20 years old or above.
- History of TIA or completed ischemic stroke
- Signed informed consent.
- Patient with score < 2 on modified Rankin's Classification of Neurological Status.
Key exclusion criteria (17 listed)
- Patients with known or suspected prior intracranial haemorrhage or history of brain injury or brain tumor.
- Disorders related to syncope, drop attacks, congenital vascular malformation, aneurysm, angioma, or epilepsy, psychiatric disorders.
- Peptic ulcer or gastrointestinal bleeding within 6 months.
- History of hypersensitivity or intolerance to study drugs or aspirin.
- Experienced habitual headache (any form) within the past 3 months.
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 |
|---|---|---|
| Aggrenox® modified release capsules | Drug | – |
| Aggrenox® modified release capsules matching placebo | Drug | – |
Primary outcome
Cumulated headache (intensity x frequency) over the first three days of treatment period
1 secondary outcome
Proportion of (1) subjects drop out due to drug related AE and (2) experiencing grade 3 or 4 drug related headache during day 5-14, day 15-21 (reduced dose), day 5-11 (regular dose), day 7, day 28; as well as (3) Number of acetaminophen tablets used.
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 31 Oct 2013.
- Related InfoLink provided by the sponsor.
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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.
Boehringer Ingelheim Study Coordinator study chair
B.I. Taiwan Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aggrenox® modified release capsules in people with Cerebrovascular Accident, run by Boehringer Ingelheim at 1 site in Taiwan.
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 4 inclusion and 17 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 31 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 frequency) over the first three days of treatment period. 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 31 Oct 2013.