Safety And Efficacy Of Spirinolactone Plus Hydroflumethia... | NCT01260857

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

NCT01260857

Sponsor

Pfizer

Status

Withdrawn

Last Update Posted

May 14, 2013Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Hypertension

Interventions

Aldazide

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Feb 2015Estimated

Completion Date

Feb 2015Estimated

First Submitted Date

Dec 14, 2010

First Submission Date that Met QC Criteria

Dec 14, 2010

First Posted Date

Dec 15, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 13, 2013

Last Update Posted Date

May 14, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Prospective, non-interventional non-probability sampling

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aldazide	Drug	Aldazide 25 mg OD		Spirinolactone + Hydroflumethiazide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Report of Adverse Events occurence (Safety)		8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Systolic BP in mmHg		8 weeks
Diastolic BP in mmHg		8 weeks
% of patients reaching BP goal of <140/90 mmHg and <130/80 mmHg for DM and proteinuric patients

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

References Module

Citations

Not provided

ID	Term
D006973	Hypertension
D003920	Diabetes Mellitus
D011507	Proteinuria

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases

ID	Term
D001581	Benzothiadiazines
D013449	Sulfonamides
D013450	Sulfones
D013457	Sulfur Compounds