Text Size

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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01260857
First received: December 14, 2010
Last updated: May 13, 2013
Last verified: May 2013
History of Changes
  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:

U.S. FDA Resources

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

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov 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:
Spirinolactone
Hydroflumethiazide
Hypertension
 Filipinos
Diabetes mellitus
Proteinuria

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydroflumethiazide
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
 Pharmacologic Actions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013