Safety And Efficacy Of Spirinolactone Plus Hydroflumethiazide In The Treatment Of Filipino Patients With Hypertension
NCT01260857
Last updated date
ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- 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.
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- 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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Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| 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:
| |||
| 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 | |||