Safety And Efficacy Of Spirinolactone Plus Hydroflumethiazide In The Treatment Of Filipino Patients With Hypertension
NCT01260857
ABOUT THIS STUDY
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- Patients >/= 18 years old with Stage 1 or 2 hypertension not controlled by monotherapy or by a combination of anti-hypertensives without any diuretic yet.
- Pregnant or lactating women, with hypersensitivity to Aldazide, patients with
resistant hypertension not controlled by a combination therapy with a diuretic in
their regimen
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Descriptive Information | ||||
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Brief Title | Safety And Efficacy Of Spirinolactone Plus Hydroflumethiazide In The Treatment Of Filipino Patients With Hypertension | |||
Official Title | An Open Label, Observational, Post Marketing Surveillance Study To Assess The Safety And Efficacy Of The Spironolactone Plus Hydroflumethiazide (Aldazide) In The Treatment Of Filipino Patients With Stage 1 To 2 Hypertension | |||
Brief Summary | Aldazide 25 mg OD will be given to Filipino hypertensive patients, and there will be 2 follow-up visits on week 4 and week 8 to monitor for safety and efficacy as primary and secondary outcomes, respectively. | |||
Detailed Description | Prospective, non-interventional non-probability sampling | |||
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 ages >/= 18 years old with Stage 1 or 2 hypertension | |||
Condition | Hypertension | |||
Intervention | Drug: Aldazide
Aldazide 25 mg OD Other Name: Spirinolactone + Hydroflumethiazide | |||
Study Groups/Cohorts | Not Provided | |||
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Recruitment Status | Withdrawn | |||
Actual Enrollment | 0 | |||
Original Estimated Enrollment | 3000 | |||
Estimated Study Completion Date | February 2015 | |||
Estimated Primary Completion Date | February 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
| |||
Ages | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01260857 | |||
Other Study ID Numbers | A6821003 | |||
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 | May 2013 |