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

Overview

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

Interventions

  • 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 CT.gov Call Center, Study Director, Pfizer

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