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

This study has been withdrawn prior to enrollment.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: December 14, 2010
Last updated: May 13, 2013
Last verified: May 2013
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
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:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Report of Adverse Events occurence (Safety) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Systolic BP in mmHg [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Diastolic BP in mmHg [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • % of patients reaching BP goal of <140/90 mmHg and <130/80 mmHg for DM and proteinuric patients [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

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:
    Drug: Aldazide
    Aldazide 25 mg OD
    Other Name: Spirinolactone + Hydroflumethiazide
Detailed Description:
Prospective, non-interventional non-probability sampling

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients ages >/= 18 years old with Stage 1 or 2 hypertension

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01260857

Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer Identifier: NCT01260857     History of Changes
Other Study ID Numbers: A6821003 
Study First Received: December 14, 2010
Last Updated: May 13, 2013
Health Authority: Philippines: Bureau of Food and Drugs

Keywords provided by Pfizer:
Diabetes mellitus

Additional relevant MeSH terms:
Cardiovascular Diseases
Vascular Diseases
Antihypertensive Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors processed this record on May 24, 2016