Safety And Efficacy Of Spirinolactone Plus Hydroflumethiazide In The Treatment Of Filipino Patients With Hypertension


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.

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: February 2015

Detailed Description

Prospective, non-interventional non-probability sampling


  • Drug: Aldazide
    • Aldazide 25 mg OD

Clinical Trial Outcome Measures

Primary Measures

  • Report of Adverse Events occurence (Safety)
    • Time Frame: 8 weeks

Secondary Measures

  • Systolic BP in mmHg
    • Time Frame: 8 weeks
  • Diastolic BP in mmHg
    • Time Frame: 8 weeks
  • % of patients reaching BP goal of <140/90 mmHg and <130/80 mmHg for DM and proteinuric patients
    • Time Frame: 8 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • 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:
  • Pregnant or lactating women, with hypersensitivity to Aldazide, patients with resistant hypertension not controlled by a combination therapy with a diuretic in their regimen
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: 65 Years

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Pfizer
    • Provider of Information About this Clinical Study
      • Sponsor
    • Overall Official(s)
      • Pfizer Call Center, Study Director, Pfizer

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