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

This study has been withdrawn prior to enrollment.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01260857

First Posted: December 15, 2010

Last Update Posted: May 14, 2013

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Pfizer

Purpose

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.

Condition	Intervention	Phase
Hypertension	Drug: Aldazide	Phase 4


Study Type:	Observational
Study Design:	Time Perspective: Prospective
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

Resource links provided by NLM:

Drug Information available for: Hydroflumethiazide

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Report of Adverse Events occurence (Safety) [ Time Frame: 8 weeks ]

Secondary Outcome 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 ]


Enrollment:	0
Study Start Date:	March 2013
Estimated Study Completion Date:	February 2015
Estimated Primary Completion Date:	February 2015 (Final data collection date for primary outcome measure)

Intervention Details:

Aldazide 25 mg OD

Other Name: Spirinolactone + Hydroflumethiazide

Detailed Description:

Prospective, non-interventional non-probability sampling

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

patients ages >/= 18 years old with Stage 1 or 2 hypertension

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01260857

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site


Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01260857 History of Changes
Other Study ID Numbers:	A6821003
First Submitted:	December 14, 2010
First Posted:	December 15, 2010
Last Update Posted:	May 14, 2013
Last Verified:	May 2013

Keywords provided by Pfizer:


Spirinolactone Hydroflumethiazide Hypertension	Filipinos Diabetes mellitus Proteinuria

Additional relevant MeSH terms:


Hypertension Vascular Diseases Cardiovascular Diseases Hydroflumethiazide Antihypertensive Agents Diuretics	Natriuretic Agents Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action

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