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

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ClinicalTrials.gov Identifier: NCT01260857
Recruitment Status : Withdrawn
First Posted : December 15, 2010
Last Update Posted : May 14, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment
Hypertension Drug: Aldazide

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

Study Design
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Study Type : Observational
Actual Enrollment : 0 participants
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
Study Start Date : March 2013
Estimated Primary Completion Date : February 2015
Estimated Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Intervention Details:
    Drug: Aldazide
    Aldazide 25 mg OD
    Other Name: Spirinolactone + Hydroflumethiazide

Outcome Measures
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Primary Outcome Measures :
  1. Report of Adverse Events occurence (Safety) [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Systolic BP in mmHg [ Time Frame: 8 weeks ]
  2. Diastolic BP in mmHg [ Time Frame: 8 weeks ]
  3. % of patients reaching BP goal of <140/90 mmHg and <130/80 mmHg for DM and proteinuric patients [ Time Frame: 8 weeks ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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 Posted: December 15, 2010    Key Record Dates
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