Headache Study to Compare Aggrenox Full Dose and Reduced Dose
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
Drug: Aggrenox® modified release capsules
Drug: Aggrenox® modified release capsules matching placebo
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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|
- Cumulated headache (intensity x frequency) over the first three days of treatment period
- 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.
|Study Start Date:||September 2002|
|Estimated Study Completion Date:||April 2003|
|Primary Completion Date:||April 2003 (Final data collection date for primary outcome measure)|
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.
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
Compare Aggrenox full dose, reduced dose and placebo