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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01353963
First received: May 12, 2011
Last updated: December 4, 2015
Last verified: December 2015
  Purpose
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.

Condition Intervention Phase
Major Depressive Disorder
Vasomotor Symptoms
Drug: desvenlafaxine succinate
Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs), or Discontinuation Due to Adverse Events (AEs) [ Time Frame: Week 4 to Week 8 ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 8. [ Time Frame: Week 8 ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Heart Rate at Week 4. [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Heart Rate at Week 8. [ Time Frame: Week 8 ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Weight at Week 4. [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Weight at Week 8. [ Time Frame: Week 8 ] [ Designated as safety issue: Yes ]

Enrollment: 13
Study Start Date: March 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 Drug: desvenlafaxine succinate
50 mg tablet once daily
Other Name: Pristiq

Detailed Description:
post marketing surveillance none
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with major depressive disorder and vasomotor symptoms secondary to menopause prescribed with desvenlafaxine succinate
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Hypersensitivity to desvenlafaxine succinate

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01353963

Locations
Philippines
Private Clinic
Las Pinas, Philippines
Private Clinic
Manila, Philippines
Private Clinic
Pasay City, Philippines
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01353963     History of Changes
Other Study ID Numbers: B2061038 
Study First Received: May 12, 2011
Results First Received: December 4, 2015
Last Updated: December 4, 2015
Health Authority: Philippines: Food and Drug Administration (FDA)

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Desvenlafaxine Succinate
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 28, 2016