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.
Patients diagnosed with major depressive disorder and vasomotor symptoms secondary to
menopause prescribed with desvenlafaxine succinate
Hypersensitivity to desvenlafaxine succinate
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| 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 | |||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
