Headache Study to Compare Aggrenox Full Dose and Reduced Dose

NCT00274586 | Completed Phase 3

• 1 other identifier: 9.155
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Cerebrovascular Accident

Outcome Measures

Primary Outcomes (1)

• 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.

Interventions

Aggrenox® modified release capsules DRUG

Aggrenox® modified release capsules matching placebo DRUG

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taipei, 105, Taiwan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Boehringer Ingelheim Study Coordinator

  B.I. Taiwan Ltd.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 10, 2006
• First Posted: January 11, 2006
• Study Start: September 1, 2002
• Primary Completion: April 1, 2003
• Study Completion: April 1, 2003
• Last Updated: October 31, 2013

Record last verified: 2013-10

Locations

TW (1)