Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 15 of 89 for:    DESVENLAFAXINE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date May 12, 2011
First Posted Date May 16, 2011
Results First Submitted Date December 4, 2015
Results First Posted Date January 18, 2016
Last Update Posted Date January 18, 2016
Study Start Date March 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 4, 2015)
  • 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.
  • Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 4. [ Time Frame: Week 4 ]
  • Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 8. [ Time Frame: Week 8 ]
  • Change From Baseline in Heart Rate at Week 4. [ Time Frame: Week 4 ]
  • Change From Baseline in Heart Rate at Week 8. [ Time Frame: Week 8 ]
  • Change From Baseline in Weight at Week 4. [ Time Frame: Week 4 ]
  • Change From Baseline in Weight at Week 8. [ Time Frame: Week 8 ]
Original Primary Outcome Measures
 (submitted: May 12, 2011)
Safety assessments as measured by evaluating any reported adverse events, scheduled physical examinations and vital signs assessments. [ Time Frame: 30 days ]
Change History Complete list of historical versions of study NCT01353963 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Desvenlafaxine Succinate (Pristiq): Postmarketing Surveillance Study Among Filipino Patients
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
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 Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients diagnosed with major depressive disorder and vasomotor symptoms secondary to menopause prescribed with desvenlafaxine succinate
Condition
  • Major Depressive Disorder
  • Vasomotor Symptoms
Intervention Drug: desvenlafaxine succinate
50 mg tablet once daily
Other Name: Pristiq
Study Groups/Cohorts 1
Intervention: Drug: desvenlafaxine succinate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: January 9, 2015)
13
Original Estimated Enrollment
 (submitted: May 12, 2011)
3000
Actual Study Completion Date August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Philippines
Removed Location Countries  
 
Administrative Information
NCT Number NCT01353963
Other Study ID Numbers B2061038
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date December 2015