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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
International Clinical Trials Association
Information provided by:

Brief Summary:
This study will describe the factors influencing the physician in face of elevated blood pressure in already treated patients

Condition or disease Intervention/treatment
Arterial Hypertension Drug: Telmisartan (Kinzal/Pritor, BAY68-9291)

Study Type : Observational
Actual Enrollment : 1589 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Study Start Date : November 2009
Primary Completion Date : September 2010
Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Telmisartan
U.S. FDA Resources

Group/Cohort Intervention/treatment
Group 1 Drug: Telmisartan (Kinzal/Pritor, BAY68-9291)
Patients under daily life treatment receiving Pritor according to local drug information.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Analyses of the factors that had an impact on the therapeutic decision [ Time Frame: on day 1 ]

Biospecimen Retention:   None Retained

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01071681

Many Locations, France
Sponsors and Collaborators
International Clinical Trials Association
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Medical Director, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT01071681     History of Changes
Other Study ID Numbers: 14675
KL0911FR ( Other Identifier: Company Internal )
BI INTENS ( Other Identifier: Company Internal )
First Posted: February 19, 2010    Key Record Dates
Last Update Posted: November 2, 2011
Last Verified: November 2011

Keywords provided by Bayer:
Arterial hypertension

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action