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

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ClinicalTrials.gov Identifier: NCT01353963
Recruitment Status : Terminated
First Posted : May 16, 2011
Results First Posted : January 18, 2016
Last Update Posted : January 18, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Major Depressive Disorder Vasomotor Symptoms Drug: desvenlafaxine succinate

Detailed Description:
post marketing surveillance none

Study Type : Observational
Actual Enrollment : 13 participants
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
Study Start Date : March 2012
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
1 Drug: desvenlafaxine succinate
50 mg tablet once daily
Other Name: Pristiq



Primary Outcome Measures :
  1. 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 ]
    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.

  2. Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 4. [ Time Frame: Week 4 ]
  3. Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 8. [ Time Frame: Week 8 ]
  4. Change From Baseline in Heart Rate at Week 4. [ Time Frame: Week 4 ]
  5. Change From Baseline in Heart Rate at Week 8. [ Time Frame: Week 8 ]
  6. Change From Baseline in Weight at Week 4. [ Time Frame: Week 4 ]
  7. Change From Baseline in Weight at Week 8. [ Time Frame: Week 8 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01353963     History of Changes
Other Study ID Numbers: B2061038
First Posted: May 16, 2011    Key Record Dates
Results First Posted: January 18, 2016
Last Update Posted: January 18, 2016
Last Verified: December 2015

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