NCT00618956

A Study Of Milnacipran In Patients With Fibromyalgia: Effects On 24 Hour Ambulatory Blood Pressure Monitoring

A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of Milnacipran 100 And 200 MG Daily in Patients With Fibromyalgia: Effects On 24 Hour Ambulatory Blood Pressure

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 321 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The study is designed to accurately assess any changes in blood pressure and pulse at 100 and 200 mg daily dose of milnacipran in patients with fibromyalgia syndrome.

Detailed description

This study is double blind (neither you nor the physician will know if you are receiving active study drug or placebo, an inactive compound such as a sugar pill) and it is being conducted at various research centers in the United States. If the study staff determines that you are eligible and you decide to participate, there will be approximately 11 study visits in about 3 months. During these visits, you will undergo routine health exams and complete different kinds of questionnaires. This study requires that you wear a blood pressure cuff continuously for 24 hours on three separate occasions. You will also be required to make multiple same-day visits to the study site on three separate occasions for blood draws.

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
DRUG	Milnacipran hydrochloride	Milnacipran 100 to 200 mg/day tablet (administered in divided doses, twice daily \[BID\]), oral administration.
DRUG	Placebo	Placebo

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-07-01
• First posted: 2008-02-20
• Last updated: 2009-11-20
• Results posted: 2009-09-03

Locations

38 sites across 1 country: United States