The Real-Life Efficacy and Safety of Telmisartan in Patie... | NCT00471003

Studies
The Real-Life Efficacy and Safety of Telmisartan in Patients With Arterial Hypertension

NCT00471003

Sponsor

Bayer

Status

Completed

Last Update Posted

Jan 20, 2010Estimated

Enrollment

5,448Actual

Phase

Not provided

Conditions

Hypertension

Interventions

Pritor (Telmisartan , BAY68-9291)

Countries

Croatia
Poland
Slovakia
Slovenia

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 2010

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

Sep 2006

Primary Completion Date

Nov 2009Actual

Completion Date

Nov 2009Actual

First Submitted Date

May 7, 2007

First Submission Date that Met QC Criteria

May 7, 2007

First Posted Date

May 8, 2007Estimated

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 19, 2010

Last Update Posted Date

Jan 20, 2010Estimated

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

The main purpose of this study is to asses the efficacy and safety of telmisartan, with the special attention on the influence of telmisartan on selected metabolic parameters of patients.

Detailed Description

Not provided

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

5,448Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1			Drug: Pritor (Telmisartan , BAY68-9291)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pritor (Telmisartan , BAY68-9291)	Drug	Primary care hypertensive patients starting the therapy with Telmisartan	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy and safety of the treatment with telmisartan reported by the physician		At the both of planned control visits. (Approx. interval between visits 3 months)

Secondary Outcomes

Measure	Description	Time Frame
Changes in metabolic parameters in telmisartan treated patients		At the both of planned control visits. (Approx. interval between visits 3 months)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age over 18
Untreated or ineffectively treated arterial hypertension

Exclusion Criteria:

Cholestatic disorders and severe hepatic failure
Allergy to telmisartan
Pregnancy and lactation period

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Primary care clinic

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077333	Telmisartan

Ancestor Terms

ID	Term
D001713	Biphenyl Compounds
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
KL0601PL
13929 - KL0601SI
12804 - KL0601SK
14326 - KL0601HR

Facility	Status	City	State	ZIP	Country	Contacts
		Many Locations			Croatia