NCT00701389

Study to Evaluate the Safety, Tolerability, and Blood Pressure Effect of an Oral Dose of Sumatriptan Alone and in Combination With MK-0974 (Telcagepant) in Migraine Patients (0974-026)

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Study to understand the effects of migraine treatments on blood pressure in participants with migraine. The primary hypothesis is that the effect on semi-recumbent mean arterial pressure following the coadministration of telcagepant and sumatriptan is similar to that following administration of sumatriptan alone. That is, the true mean treatment difference (sumatriptan with telcagepant sumatriptan alone) in time-weighted mean arterial pressure for 2.5 hours following dosing is less than 5 mmHg.

Conditions

• Migraine Disorders

Interventions

Type	Name	Description
DRUG	telcagepant potassium	Single oral dose of 2 x 300 mg capsules.
DRUG	sumatriptan	single oral dose of 100 mg sumatriptan
DRUG	sumatriptan placebo	single oral dose
DRUG	telcagepant potassium placebo	single oral dose of 2 MK-0974 placebo capsules

Timeline

• Start date: 2007-11-20
• Primary completion: 2008-04-10
• Completion: 2008-04-10
• First posted: 2008-06-19
• Last updated: 2018-10-17
• Results posted: 2014-09-08