Study to Evaluate the Safety, Tolerability, and Blood Pressure Effect of an Oral Dose of Sumatriptan Alone and in Combination With MK0974 in Migraine Patients
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Migraine Disorders
Intervention: MK0974 (Drug); sumatriptan (Drug); placebo (unspecified) (Drug); placebo (unspecified) (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
Study to understand the effects of blood pressure in patients with migraine.
Clinical Details
Official title: A Double-Blind, Randomized, Placebo-Controlled, 3-Period, Single Dose Crossover Study to Evaluate the Safety, Tolerability, and Blood Pressure Effect of an Oral Dose of Sumatriptan Alone and in Combination With MK0974 in Migraine Patients
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Crossover Assignment, Safety Study
Primary outcome: Assessment of the blood pressure effect of a single dose of comparator alone versus comparator with investigational product in migraineurs.
Secondary outcome: Assessment of the safety and tolerability of a single dose of comparator alone versus comparator with investigational product in migraineurs. Assessment of the blood pressure effect of a single dose of investigational product vs. placebo in migraineurs.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patient has history of migraine for longer than 6 months.
- Patient is free from migraine 24 hours before each dosing.
- Patient is judged to be in good health.
- Nonsmoker
Exclusion Criteria:
- Under age of legal consent.
- Legally or mentally incapacitated or has significant emotional problems.
- Patient is taking any medications from about 2 weeks before the first dose of study
medication.
- Patient has had surgery or donated blood or participated in another investigation
study within 4 weeks prior to screening
- Patient is currently a regular user of any illicit drugs or has a history of
drug/alcohol abuse within about 2 years
- Patient consumes more than 6 caffeinated beverages per day
Locations and Contacts
Additional Information
Starting date: December 2007
Ending date: April 2008
Last updated: June 18, 2008
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