Survey to Assess Why People Are Not Responding to Treatme... | NCT01071681

Studies
Survey to Assess Why People Are Not Responding to Treatment in Hypertension

NCT01071681

Sponsor

Bayer

Status

Completed

Last Update Posted

Nov 2, 2011Estimated

Enrollment

1,589Actual

Phase

Not provided

Conditions

Arterial Hypertension

Interventions

Telmisartan (Kinzal/Pritor, BAY68-9291)

Countries

France

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

ID	Type	Description	Link
KL0911FR	Other Identifier	Company Internal
BI INTENS	Other Identifier	Company Internal

Official Title

Observational Survey Assessing the Factors of Treatment Intensification in Uncontrolled Hypertensive Patients Under a Combination Therapy, Either Fixed or Not, of a Renin-Angiotensin System Blocker (RASB) and Hydrochlorothiazide (HCTZ), According to Their Level of Cardiovascular Risk.

Status Module

Record Verification Date

Nov 2011

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

Nov 2009

Primary Completion Date

Sep 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Oct 1, 2009

First Submission Date that Met QC Criteria

Feb 18, 2010

First Posted Date

Feb 19, 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

Nov 1, 2011

Last Update Posted Date

Nov 2, 2011Estimated

Name	Class
International Clinical Trials Association	OTHER

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 study will describe the factors influencing the physician in face of elevated blood pressure in already treated 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

1,589Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Telmisartan (Kinzal/Pritor, BAY68-9291)	Drug	Patients under daily life treatment receiving Pritor according to local drug information.	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of patients, according to the level of cardiovascular risk, who, at the end of the visit:- do not present any modification of hypertension treatment (therapeutic inertia) - present a change in the hypertension therapeutic		on day 1

Secondary Outcomes

Measure	Description	Time Frame
Analyses of the factors that had an impact on the therapeutic decision		on day 1

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men or women over 18
Hypertensive patients
Uncontrolled hypertension (blood pressure >/=140/90 mmHg on the day of consultation or >/=130/80 mmHg in diabetic patients or in patients suffering from kidney failure, or in elderly patients with a systolic blood pressure >/=150 mmHg (in the absence of orthostatic hypotension)
Patients treated with a combination, fixed or not, of Renin-Angiotensin System Blocker (RASB) + Hydrochlorothiazide (HCTZ)
Patients examined in common medical care practice, whatever the reason for consultation
Patients informed of the study

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

Uncontrolled hypertensive patients under a combination therapy, either fixed or not, of a renin-angiotensin system blocker and hydrochlorothiazide

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