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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)

NCT00701389 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-10-17

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-20
Primary Completion
2008-04-10
Completion
2008-04-10

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00701389 on ClinicalTrials.gov