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

Major Depressive Disorder Clinical Trial

Official title:

An Open Label, Non-interventional Study Of The Safety Of Desvenlafaxine Succinate (Pristiq) In The Treatment Of Major Depressive Disorder (Mdd) And Vasomotor Symptoms (Vms) Associated With Menopause In Filipino Adult Patients: A Post Marketing Surveillance Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01353963
• Other study ID #: B2061038
• Status: Terminated
• Phase: Phase 4
• First received: May 12, 2011
• Last updated: December 4, 2015
• Start date: March 2012
• Est. completion date: August 2012

Study information

• Verified date: December 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Food and Drug Administration (FDA)
• Study type: Observational

Clinical Trial 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.

Description:

post marketing surveillance none

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Vasomotor Symptoms

Intervention

Drug:
• desvenlafaxine succinate
50 mg tablet once daily

Locations

Country	Name	City	State
Philippines	Private Clinic	Las Pinas
Philippines	Private Clinic	Manila
Philippines	Private Clinic	Pasay City

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs), or Discontinuation Due to Adverse Events (AEs)	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.	Week 4 to Week 8	Yes
Primary	Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 4.		Week 4	Yes
Primary	Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 8.		Week 8	Yes
Primary	Change From Baseline in Heart Rate at Week 4.		Week 4	Yes
Primary	Change From Baseline in Heart Rate at Week 8.		Week 8	Yes
Primary	Change From Baseline in Weight at Week 4.		Week 4	Yes
Primary	Change From Baseline in Weight at Week 8.		Week 8	Yes

External Links

•   To obtain contact information for a study center near you, click here.