Survey to Assess Why People Are Not Responding to Treatment in Hypertension
This study has been completed.
Sponsor:
Bayer
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
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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:
MedlinePlus related topics:
High Blood Pressure
Drug Information available for:
Telmisartan
U.S. FDA Resources
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 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 May 23, 2013