Post-Marketing Surveillance Of Olmesartan Medoxomil In Co... | NCT00796159

Studies
Post-Marketing Surveillance Of Olmesartan Medoxomil In Combination With Hydrochlorothiazide

NCT00796159

Sponsor

Pfizer

Status

Completed

Last Update Posted

Dec 23, 2009Estimated

Enrollment

1,723Actual

Phase

Not provided

Conditions

Hypertension

Interventions

Olmesartan medoxomil

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

Dec 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2007

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Nov 20, 2008

First Submission Date that Met QC Criteria

Nov 21, 2008

First Posted Date

Nov 24, 2008Estimated

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

Dec 21, 2009

Last Update Posted Date

Dec 23, 2009Estimated

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

This is a Post-Marketing Surveillance study evaluating the Efficacy, Tolerability and Safety of Olmesartan medoxomil 20 mg in combination with 12.5 MG of hydrochlorothiazide in subjects with mild to moderate essential hypertension

Detailed Description

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

1,723Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Olmesartan medoxomil + HCTZ			Drug: Olmesartan medoxomil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Olmesartan medoxomil	Drug	olmesartan medoxomil 20 mg and HCTZ 12.5 mg	Olmesartan medoxomil + HCTZ

Measure	Description	Time Frame
Safety (Adverse Events)		4 weeks

Measure	Description	Time Frame
Blood Pressure		4 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and Female patients 18 to 65 y/old
Patient previously taking low-dose medoxomil or any other ARB alone with uncontrolled BP
Patient with uncontrolled mild to moderate hypertension (SBP>= 140 and <=179 mmHg OR DBP of >=90 and <=109 mmHg)

Exclusion Criteria:

Pregnant of Lactating women
History of secondary hypertension

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

Filipino patients with Uncontrolled Mild to Moderate Essential Hypertension

Sampling Method

Non-Probability Sample

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

References Module

Citations

Not provided

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds