NCT00792636

A Study to Determine the Effect of Sumatriptan and Naproxen Sodium Combination Tablet, Sumatriptan Tablet, and Naproxen Sodium Tablet on Blood Pressure When Treating Migraine Headaches That Occur During a 6-month Period

Assessment of the Effect of Sumatriptan and Naproxen Sodium Combination Tablet, Sumatriptan Tablet, and Naproxen Sodium Tablet Treatment on Blood Pressure When Administered Intermittently for Six Months for the Acute Treatment of Migraine Attacks, With or Without Aura, in Adults

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 407 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the effect on blood pressure of sumatriptan and naproxen sodium combination tablets, tablets containing only sumatriptan, and tablets containing only naproxen sodium when these drugs are taken to treat migraine headaches that occur during a 6-month period.

Conditions

• Migraine Disorders

Interventions

Type	Name	Description
DRUG	sumatriptan and naproxen sodium combination tablet	sumatriptan 85mg and naproxen sodium 500mg
DRUG	sumatriptan tablet	sumatriptan 85mg
DRUG	naproxen sodium tablet	Naproxen sodium 500mg

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2008-11-18
• Last updated: 2016-11-23
• Results posted: 2010-11-04

Locations

49 sites across 1 country: United States