Desvenlafaxine Succinate (Pristiq): Postmarketing Surveillance Study Among Filipino Patients
NCT01353963
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Patients diagnosed with major depressive disorder and vasomotor symptoms secondary to menopause prescribed with desvenlafaxine succinate
Hypersensitivity to desvenlafaxine succinate
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Descriptive Information | ||||
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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 |
| |||
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 | 13 | |||
Original Estimated Enrollment | 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 |
| |||
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 |
| |||
PRS Account | Pfizer | |||
Verification Date | December 2015 |