Trial Outcomes & Findings for Desvenlafaxine Succinate (Pristiq): Postmarketing Surveillance Study Among Filipino Patients (NCT NCT01353963)
NCT ID: NCT01353963
Last Updated: 2016-01-18
Results Overview
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.
Recruitment status
TERMINATED
Target enrollment
13 participants
Primary outcome timeframe
Week 4 to Week 8
Results posted on
2016-01-18
Participant Flow
Participant milestones
| Measure |
Desvenlafaxine Succinate
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.
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|---|---|
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Overall Study
STARTED
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13
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Overall Study
COMPLETED
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11
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
| Measure |
Desvenlafaxine Succinate
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.
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|---|---|
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Overall Study
Adverse Event
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2
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Baseline Characteristics
Desvenlafaxine Succinate (Pristiq): Postmarketing Surveillance Study Among Filipino Patients
Baseline characteristics by cohort
| Measure |
Desvenlafaxine Succinate
n=13 Participants
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.
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Age, Continuous
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46.5 years
STANDARD_DEVIATION 13.5 • n=5 Participants
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Sex: Female, Male
Female
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5 Participants
n=5 Participants
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Sex: Female, Male
Male
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8 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Week 4 to Week 8Population: Safety population included all participants who received at least 1 dose of study medication during the observation period.
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.
Outcome measures
| Measure |
Desvenlafaxine Succinate
n=13 Participants
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.
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs), or Discontinuation Due to Adverse Events (AEs)
Participants w ith AEs
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5 Participants
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs), or Discontinuation Due to Adverse Events (AEs)
Participants w ith SAEs
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0 Participants
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs), or Discontinuation Due to Adverse Events (AEs)
Participants discontinued due to AEs
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2 Participants
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PRIMARY outcome
Timeframe: Week 4Population: Safety population included all participants who received at least 1 dose of study medication during the observation period.
Outcome measures
| Measure |
Desvenlafaxine Succinate
n=13 Participants
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.
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Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 4.
Change from baseline in systolic BP at Week 4
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-0.5 millimeter of mercury (mmHg)
Standard Deviation 8.69
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Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 4.
Change from baseline in diastolic BP at Week 4
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-0.5 millimeter of mercury (mmHg)
Standard Deviation 9.60
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PRIMARY outcome
Timeframe: Week 8Population: Safety population included all participants who received at least 1 dose of study medication during the observation period.
Outcome measures
| Measure |
Desvenlafaxine Succinate
n=11 Participants
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.
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Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 8.
Change from baseline in systolic BP at Week 8
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-0.7 millimeter of mercury (mmHg)
Standard Deviation 7.06
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Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 8.
Change from baseline in diastolic BP at Week 8
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-1.8 millimeter of mercury (mmHg)
Standard Deviation 13.28
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PRIMARY outcome
Timeframe: Week 4Population: Safety population included all participants who received at least 1 dose of study medication during the observation period.
Outcome measures
| Measure |
Desvenlafaxine Succinate
n=13 Participants
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.
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Change From Baseline in Heart Rate at Week 4.
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1.9 beats per minute (bpm)
Standard Deviation 4.50
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PRIMARY outcome
Timeframe: Week 8Population: Safety population included all participants who received at least 1 dose of study medication during the observation period.
Outcome measures
| Measure |
Desvenlafaxine Succinate
n=11 Participants
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.
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Change From Baseline in Heart Rate at Week 8.
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0.6 bpm
Standard Deviation 5.59
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PRIMARY outcome
Timeframe: Week 4Population: Safety population included all participants who received at least 1 dose of study medication during the observation period.
Outcome measures
| Measure |
Desvenlafaxine Succinate
n=13 Participants
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.
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Change From Baseline in Weight at Week 4.
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0.1 kilogram (kg)
Standard Deviation 1.61 • Interval -4.0 to 3.0
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PRIMARY outcome
Timeframe: Week 8Population: Safety population included all participants who received at least 1 dose of study medication during the observation period.
Outcome measures
| Measure |
Desvenlafaxine Succinate
n=11 Participants
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.
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|---|---|
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Change From Baseline in Weight at Week 8.
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0.5 kg
Standard Deviation 1.69 • Interval -2.0 to 3.0
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Adverse Events
Desvenlafaxine Succinate
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Desvenlafaxine Succinate
n=13 participants at risk
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.
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Psychiatric disorders
Libido decreased
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7.7%
1/13 • Number of events 1 • Week 4 to Week 8
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Reproductive system and breast disorders
Ejaculation delayed
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15.4%
2/13 • Number of events 2 • Week 4 to Week 8
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Skin and subcutaneous tissue disorders
Pruritus
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7.7%
1/13 • Number of events 1 • Week 4 to Week 8
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Reproductive system and breast disorders
Erectile dysfunction
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7.7%
1/13 • Number of events 1 • Week 4 to Week 8
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER