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Trial record 15 of 89 for:    DESVENLAFAXINE

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

Study Type Observational
Study Design Time Perspective: Prospective
Conditions Major Depressive Disorder
Vasomotor Symptoms
Intervention Drug: desvenlafaxine succinate
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Desvenlafaxine Succinate
Hide Arm/Group Description Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
Period Title: Overall Study
Started 13
Completed 11
Not Completed 2
Reason Not Completed
Adverse Event             2
Arm/Group Title Desvenlafaxine Succinate
Hide Arm/Group Description Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
Safety population included all participants who received at least 1 dose of study medication during the observation period.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants
46.5  (13.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
5
  38.5%
Male
8
  61.5%
1.Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs), or Discontinuation Due to Adverse Events (AEs)
Hide Description 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.
Time Frame Week 4 to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study medication during the observation period.
Arm/Group Title Desvenlafaxine Succinate
Hide Arm/Group Description:
Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: Participants
Participants w ith AEs 5
Participants w ith SAEs 0
Participants discontinued due to AEs 2
2.Primary Outcome
Title Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 4.
Hide Description [Not Specified]
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study medication during the observation period.
Arm/Group Title Desvenlafaxine Succinate
Hide Arm/Group Description:
Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: millimeter of mercury (mmHg)
Change from baseline in systolic BP at Week 4 -0.5  (8.69)
Change from baseline in diastolic BP at Week 4 -0.5  (9.60)
3.Primary Outcome
Title Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 8.
Hide Description [Not Specified]
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study medication during the observation period.
Arm/Group Title Desvenlafaxine Succinate
Hide Arm/Group Description:
Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: millimeter of mercury (mmHg)
Change from baseline in systolic BP at Week 8 -0.7  (7.06)
Change from baseline in diastolic BP at Week 8 -1.8  (13.28)
4.Primary Outcome
Title Change From Baseline in Heart Rate at Week 4.
Hide Description [Not Specified]
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study medication during the observation period.
Arm/Group Title Desvenlafaxine Succinate
Hide Arm/Group Description:
Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: beats per minute (bpm)
1.9  (4.50)
5.Primary Outcome
Title Change From Baseline in Heart Rate at Week 8.
Hide Description [Not Specified]
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study medication during the observation period.
Arm/Group Title Desvenlafaxine Succinate
Hide Arm/Group Description:
Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: bpm
0.6  (5.59)
6.Primary Outcome
Title Change From Baseline in Weight at Week 4.
Hide Description [Not Specified]
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study medication during the observation period.
Arm/Group Title Desvenlafaxine Succinate
Hide Arm/Group Description:
Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: kilogram (kg)
0.1  (1.61)
7.Primary Outcome
Title Change From Baseline in Weight at Week 8.
Hide Description [Not Specified]
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study medication during the observation period.
Arm/Group Title Desvenlafaxine Succinate
Hide Arm/Group Description:
Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: kg
0.5  (1.69)
Time Frame Week 4 to Week 8
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Desvenlafaxine Succinate
Hide Arm/Group Description Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
All-Cause Mortality
Desvenlafaxine Succinate
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Desvenlafaxine Succinate
Affected / at Risk (%) # Events
Total   0/13 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Desvenlafaxine Succinate
Affected / at Risk (%) # Events
Total   5/13 (38.46%)    
Psychiatric disorders   
Libido decreased * 1  1/13 (7.69%)  1
Reproductive system and breast disorders   
Ejaculation delayed * 1  2/13 (15.38%)  2
Erectile dysfunction * 1  1/13 (7.69%)  1
Skin and subcutaneous tissue disorders   
Pruritus * 1  1/13 (7.69%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.0
Due to the low number of subjects with data available, only descriptive summaries have been presented. The outcomes measures were prioritized as per study team's discretion.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 18007181021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01353963     History of Changes
Other Study ID Numbers: B2061038
First Submitted: May 12, 2011
First Posted: May 16, 2011
Results First Submitted: December 4, 2015
Results First Posted: January 18, 2016
Last Update Posted: January 18, 2016