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