Headache Study to Compare Aggrenox Full Dose and Reduced Dose

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00274586
First received: January 10, 2006
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
Cerebrovascular Accident
Drug: Aggrenox® modified release capsules
Drug: Aggrenox® modified release capsules matching placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

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.

Estimated Enrollment: 100
Study Start Date: September 2002
Estimated Study Completion Date: April 2003
Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 20 years old or above.
  2. History of TIA or completed ischemic stroke
  3. Signed informed consent.
  4. Patient with score < 2 on modified Rankin's Classification of Neurological Status.

Exclusion Criteria:

  1. Patients with known or suspected prior intracranial haemorrhage or history of brain injury or brain tumor.
  2. Disorders related to syncope, drop attacks, congenital vascular malformation, aneurysm, angioma, or epilepsy, psychiatric disorders.
  3. Peptic ulcer or gastrointestinal bleeding within 6 months.
  4. History of hypersensitivity or intolerance to study drugs or aspirin.
  5. Experienced habitual headache (any form) within the past 3 months.
  6. History of dysphasia, dysphagia, dementia, or unconsciousness.
  7. Patients currently taking other medications known to cause headaches (e.g., nitrates).
  8. Patients with deteriorating angina, subvalvular aortic stenosis or hemodynamic liability (e.g., in conjunction with a recent myocardial infarction).
  9. Uncontrolled hypertension (SBP > 220 mmHg, DBP> 120 mmHg) or life-threatening disease.
  10. Any significant disorders, such as chronic renal failure (serum creatinine > 2.0 mg/dl), neoplasia.
  11. SGPT, SGOT value greater than 2 times of the upper normal limit.
  12. Insulin dependent diabetes mellitus or poorly controlled non-insulin dependent diabetes mellitus (AC sugar > 300 mg/dl).
  13. Use of other anticoagulants, such as anti-coagulated agents or NSAIDsS.
  14. History of alcohol and/or drug abuse.
  15. Having participated in other investigational drug study within 3 months prior to study entry.
  16. Pregnant or lactating women or women of childbearing potential whom are not practicing reliable birth control.
  17. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00274586

Locations
Taiwan
Chang Gung Memorial Hospital
Taipei, Taiwan, 105
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator B.I. Taiwan Ltd.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00274586     History of Changes
Other Study ID Numbers: 9.155
Study First Received: January 10, 2006
Last Updated: October 30, 2013
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Aspirin, dipyridamole drug combination
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014