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Withdrawn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
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Condition or disease | Intervention/treatment |
---|---|
Hypertension | Drug: Aldazide |
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 |

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

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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 |
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

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
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
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 |