Desvenlafaxine Succinate (Pristiq): Postmarketing Surveillance Study Among Filipino Patients
NCT01353963
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Adult Trials: 18+ Years
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 | ||||
|---|---|---|---|---|
| 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 | |||