Survey to Assess Why People Are Not Responding to Treatment in Hypertension
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ClinicalTrials.gov Identifier: NCT01071681 |
Recruitment Status
:
Completed
First Posted
: February 19, 2010
Last Update Posted
: November 2, 2011
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Sponsor:
Bayer
Collaborator:
International Clinical Trials Association
Information provided by:
Bayer
Tracking Information | ||||
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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 |
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 |
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 |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Retention: None Retained Description: n.a |
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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. |
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Study Groups/Cohorts | Group 1
Intervention: Drug: Telmisartan (Kinzal/Pritor, BAY68-9291) |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
1589 | |||
Original Estimated Enrollment |
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:
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Sex/Gender |
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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 ) |
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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 |
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PRS Account | Bayer | |||
Verification Date | November 2011 |