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This study has been withdrawn prior to enrollment.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

December 14, 2010
May 13, 2013
March 2013
February 2015   (final data collection date for primary outcome measure)
Report of Adverse Events occurence (Safety) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01260857 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety And Efficacy Of Spirinolactone Plus Hydroflumethiazide In The Treatment Of Filipino Patients With Hypertension
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

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.

Prospective, non-interventional non-probability sampling

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Hypertension
Drug: Aldazide
Aldazide 25 mg OD
Other Name: Spirinolactone + Hydroflumethiazide
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
February 2015
February 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01260857
A6821003
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP