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

This study has been completed.

Sponsor:

Collaborator:

International Clinical Trials Association

Information provided by:

Bayer

ClinicalTrials.gov Identifier:

NCT01071681

First received: October 1, 2009

Last updated: November 1, 2011

Last verified: November 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

October 1, 2009

Last Updated Date

November 1, 2011

Start Date ^ICMJE

November 2009

Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 [ Time Frame: on day 1 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01071681 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Analyses of the factors that had an impact on the therapeutic decision [ Time Frame: on day 1 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: None Retained

Description:

n.a

Sampling Method

Non-Probability Sample

Study Population

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

Condition ^ICMJE

Arterial Hypertension

Intervention ^ICMJE

Drug: Telmisartan (Kinzal/Pritor, BAY68-9291)

Patients under daily life treatment receiving Pritor according to local drug information.

Study Group/Cohort (s)

Group 1

Intervention: Drug: Telmisartan (Kinzal/Pritor, BAY68-9291)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1589

Completion Date

September 2010

Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

France

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01071681

Other Study ID Numbers ^ICMJE

14675, KL0911FR, BI INTENS

Has Data Monitoring Committee

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Medical Director, Bayer Schering Pharma AG

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

International Clinical Trials Association

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

November 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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