Desvenlafaxine Succinate (Pristiq): Postmarketing Surveillance Study Among Filipino Patients

Terminated

• Conditions: Vasomotor Symptoms; Major Depressive Disorder
• Interventions: Drug: desvenlafaxine succinate

• Registration Number: NCT01353963
• Lead Sponsor: Pfizer

Brief Summary

This is a non-interventional study to review safety data on administration of desvenlafaxine succinate among Filipino patients with MDD and VMS per usual clinical practice within the first three years post commercial distribution.

Detailed Description

post marketing surveillance none

Study Timeline

• Study First Submitted: 2011-05-12
• Study First Submitted QC: 2011-05-12
• Study First Posted: 2011-05-16
• Study Start: 2012-03
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2015-12
• Results First Submitted: 2015-12-04
• Results First Submitted QC: 2015-12-04
• Last Update Submitted: 2015-12-04
• Results First Posted: 2016-01-18
• Last Update Posted: 2016-01-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Patients diagnosed with major depressive disorder and vasomotor symptoms secondary to menopause prescribed with desvenlafaxine succinate

Exclusion Criteria

Hypersensitivity to desvenlafaxine succinate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	desvenlafaxine succinate	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs), or Discontinuation Due to Adverse Events (AEs)	Week 4 to Week 8	An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug with regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between Week 4 and up to Week 8 that were absent before treatment or that worsened relative to pretreatment state.
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 4.	Week 4
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 8.	Week 8
Change From Baseline in Heart Rate at Week 4.	Week 4
Change From Baseline in Heart Rate at Week 8.	Week 8
Change From Baseline in Weight at Week 4.	Week 4
Change From Baseline in Weight at Week 8.	Week 8

Trial Locations

Locations (1)

Private Clinic; 🇵🇭 Pasay City, Philippines