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

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01260857

Enrollment

Registered

2010-12-15

Start date

2013-03-31

Completion date

2015-02-28

Last updated

2013-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Spirinolactone, Hydroflumethiazide, Hypertension, Filipinos, Diabetes mellitus, Proteinuria

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

Interventions

DRUGAldazide

Aldazide 25 mg OD

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Report of Adverse Events occurence (Safety)	8 weeks

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026