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

Information source: Pfizer
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Aldazide (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021


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.

Clinical Details

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

Study design: Time Perspective: Prospective

Primary outcome: Report of Adverse Events occurence (Safety)

Secondary outcome:

Systolic BP in mmHg

Diastolic BP in mmHg

% of patients reaching BP goal of <140/90 mmHg and <130/80 mmHg for DM and proteinuric patients

Detailed description: Prospective, non-interventional non-probability sampling


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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

Locations and Contacts

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: March 2013
Last updated: January 10, 2013

Page last updated: February 07, 2013

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