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

This study has been completed.
Sponsor:
Collaborator:
ICTA PM
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01071681
First received: October 1, 2009
Last updated: November 1, 2011
Last verified: November 2011
  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 ] [ Designated as safety issue: No ]

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01071681

Locations
France
Many Locations, France
Sponsors and Collaborators
Bayer
ICTA PM
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Medical Director, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT01071681     History of Changes
Other Study ID Numbers: 14675, KL0911FR, BI INTENS
Study First Received: October 1, 2009
Last Updated: November 1, 2011
Health Authority: France: French Data Protection Authority

Keywords provided by Bayer:
Arterial hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Telmisartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 15, 2014