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Headache Study to Compare Aggrenox Full Dose and Reduced Dose

Primary Purpose

Cerebrovascular Accident

Status
Completed
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
Aggrenox® modified release capsules
Aggrenox® modified release capsules matching placebo
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Accident

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Sites / Locations

  • Chang Gung Memorial Hospital

Outcomes

Primary Outcome Measures

Cumulated headache (intensity x frequency) over the first three days of treatment period

Secondary Outcome Measures

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.

Full Information

First Posted
January 10, 2006
Last Updated
October 30, 2013
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00274586
Brief Title
Headache Study to Compare Aggrenox Full Dose and Reduced Dose
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
April 2003 (Actual)
Study Completion Date
April 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief 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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Aggrenox® modified release capsules
Intervention Type
Drug
Intervention Name(s)
Aggrenox® modified release capsules matching placebo
Primary Outcome Measure Information:
Title
Cumulated headache (intensity x frequency) over the first three days of treatment period
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim Study Coordinator
Organizational Affiliation
B.I. Taiwan Ltd.
Official's Role
Study Chair
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taipei
ZIP/Postal Code
105
Country
Taiwan

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/9/9.155.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/9/9.155_literature.pdf
Description
Related Info

Learn more about this trial

Headache Study to Compare Aggrenox Full Dose and Reduced Dose

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