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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01071681
First Posted: February 19, 2010
Last Update Posted: November 2, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
International Clinical Trials Association
Information provided by:
Bayer
  Purpose
This study will describe the factors influencing the physician in face of elevated blood pressure in already treated patients

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

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Bayer:

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 ]

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

Biospecimen Retention:   None Retained
n.a

Enrollment: 1589
Study Start Date: November 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Telmisartan (Kinzal/Pritor, BAY68-9291)
Patients under daily life treatment receiving Pritor according to local drug information.

  Eligibility

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
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
  Contacts and Locations
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


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

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 Submitted: October 1, 2009
First Posted: February 19, 2010
Last Update Posted: November 2, 2011
Last Verified: November 2011

Keywords provided by Bayer:
Arterial hypertension

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