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

Tracking Information
First Submitted Date	October 1, 2009
First Posted Date	February 19, 2010
Last Update Posted Date	November 2, 2011
Study Start Date	November 2009
Actual Primary Completion Date	September 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: February 18, 2010)	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 ]
Original Primary Outcome Measures	Same as current
Change History	Complete list of historical versions of study NCT01071681 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: February 18, 2010)	Analyses of the factors that had an impact on the therapeutic decision [ Time Frame: on day 1 ]
Original Secondary Outcome Measures	Same as current
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Survey to Assess Why People Are Not Responding to Treatment in Hypertension
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.
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	Observational
Study Design	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	Arterial Hypertension
Intervention	Drug: Telmisartan (Kinzal/Pritor, BAY68-9291); Patients under daily life treatment receiving Pritor according to local drug information.
Study Groups/Cohorts	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	Completed
Actual Enrollment; (submitted: October 11, 2010)	1589
Original Estimated Enrollment; (submitted: February 18, 2010)	3000
Actual Study Completion Date	September 2010
Actual Primary Completion Date	September 2010 (Final data collection date for primary outcome measure)
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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	France
Removed Location Countries
Administrative Information
NCT Number	NCT01071681
Other Study ID Numbers	14675; KL0911FR ( Other Identifier: Company Internal ); BI INTENS ( Other Identifier: Company Internal )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Medical Director, Bayer Schering Pharma AG
Study Sponsor	Bayer
Collaborators	International Clinical Trials Association
Investigators	Study Director: Bayer Study Director Bayer
PRS Account	Bayer
Verification Date	November 2011