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

Withdrawn

• Conditions: Hypertension

• Registration Number: NCT01260857
• Lead Sponsor: Pfizer

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 Timeline

• Study First Submitted: 2010-12-14
• Study First Submitted QC: 2010-12-14
• Study First Posted: 2010-12-15
• Study Start: 2013-03
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-13
• Last Update Posted: 2013-05-14
• Primary Completion: 2015-02
• Study Completion: 2015-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Report of Adverse Events occurence (Safety)	8 weeks

Secondary Outcome Measures

Name	Time	Method
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