Epidemiological Study In Hypertensive Patients: Assessmen... | NCT00709787

Studies
Epidemiological Study In Hypertensive Patients: Assessment Of Risk Factors Prevalence And Of Patients' Management

NCT00709787

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Status

Completed

Last Update Posted

Jan 27, 2021Actual

Enrollment

899Actual

Phase

Not provided

Conditions

Hypertension

Interventions

Usual Care

Countries

Croatia
Czechia

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

Jan 2021

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

Jun 2008

Primary Completion Date

Feb 2009Actual

Completion Date

Feb 2009Actual

First Submitted Date

Jul 1, 2008

First Submission Date that Met QC Criteria

Jul 1, 2008

First Posted Date

Jul 3, 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

Jan 26, 2021

Last Update Posted Date

Jan 27, 2021Actual

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

To assess the pattern of hypertension in the population in terms of presence of additional risk factors (ARF) and cardiovascular risk stratification.

Detailed Description

routine physician visits

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

899Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hypertensive Subjects undergoing primary prevention			Other: Usual Care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Usual Care	Other	Normal care for hypertensive patients with risk factors for CHD	Hypertensive Subjects undergoing primary prevention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Description of hypertensive patients in terms of presence of associated cardiovascular (CV) risk factors (number of additional CV risk factors and frequency)

Secondary Outcomes

Measure	Description	Time Frame
Description of pattern of management of HT and CVD prevention, through lifestyle and use of drug therapies,
Estimate adherence to treatment using the Morisky Adherence Scale (MAS)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 to 80 years old
Patients with hypertension: newly diagnosed and /or already diagnosed and treated , whether at goal or not for the blood pressure level;
Patients with no history of CHD/CVD

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Adult Hypertensive Patients managed in primary care

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Varaždin		42000	Croatia
Pfizer Investigational Site

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension
D003327	Coronary Disease

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D017202	Myocardial Ischemia
D006331	Heart Diseases

Browse Leaves

Not provided

Browse Branches

Not provided