At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 321 enrolled
Drug / intervention
Milnacipran hydrochloride +1 moredrug
Likely dose
Milnacipran hydrochloride 200 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.
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
In Brief
A Phase 3 clinical trial evaluating Milnacipran hydrochloride and Placebo for Fibromyalgia. Completed, enrolled 321 participants across 38 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibromyalgia
CountriesUnited States
CollaboratorsCypress Bioscience, Inc.
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2007
First PostedFeb 2008
Primary CompletionJul 2008
TodayJul 2026
First PostedFeb 20, 2008
Enrollment StartOct 1, 2007
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 18.4 years ago
Interventions
Milnacipran hydrochloridedrug
Milnacipran 100 to 200 mg/day tablet (administered in divided doses, twice daily \[BID\]), oral administration.
Placebodrug
Placebo