CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
telcagepant potassium +3 moredrug
Likely dose
telcagepant potassium 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00701389
NCT00701389Phase 1Completed

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

Merck Sharp & Dohme LLC·interventional·Posted Jun 19, 2008·Updated Oct 17, 2018

In Brief

A Phase 1 clinical trial evaluating telcagepant potassium, sumatriptan, and 2 other interventions for Migraine Disorders. Completed, enrolled 24 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 19, 2008
Enrollment StartNov 20, 2007
Primary CompletionApr 10, 2008
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 18.0 years ago

Interventions

telcagepant potassiumdrug

Single oral dose of 2 x 300 mg capsules.

sumatriptandrug

single oral dose of 100 mg sumatriptan

sumatriptan placebodrug

single oral dose

telcagepant potassium placebodrug

single oral dose of 2 MK-0974 placebo capsules