- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01071681
Survey to Assess Why People Are Not Responding to Treatment in Hypertension
November 1, 2011 updated by: Bayer
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.
This study will describe the factors influencing the physician in face of elevated blood pressure in already treated patients
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
1589
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Many Locations, France
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group 1
|
Patients under daily life treatment receiving Pritor according to local drug information.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
on day 1
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Analyses of the factors that had an impact on the therapeutic decision
Time Frame: on day 1
|
on day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (ACTUAL)
September 1, 2010
Study Completion (ACTUAL)
September 1, 2010
Study Registration Dates
First Submitted
October 1, 2009
First Submitted That Met QC Criteria
February 18, 2010
First Posted (ESTIMATE)
February 19, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
November 2, 2011
Last Update Submitted That Met QC Criteria
November 1, 2011
Last Verified
November 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14675
- KL0911FR (OTHER: Company Internal)
- BI INTENS (OTHER: Company Internal)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Arterial Hypertension
-
Vanderbilt University Medical CenterJohns Hopkins UniversityCompletedPulmonary Arterial Hypertension | Idiopathic Pulmonary Arterial Hypertension | Associated Pulmonary Arterial Hypertension | Heritable Pulmonary Arterial HypertensionUnited States
-
National Institute of Cardiology, Laranjeiras,...CompletedArterial Hypertension | Resistant Arterial HypertensionBrazil
-
Klinikum Wels-GrieskirchenEuropean Regional Development Fund; Austrian Society of Hypertension; I.E.M....CompletedSuspected Arterial HypertensionSwitzerland, Austria, Germany, Greece, Italy, Spain, United Kingdom
-
Heart Center Leipzig - University HospitalCompletedTherapy Resistant Arterial HypertensionGermany
-
ActelionRecruitingArterial Hypertension, PulmonaryPoland, Germany
-
University of GiessenPhilipps University Marburg Medical CenterRecruitingPulmonary Arterial Hypertension (PAH)Germany
-
Novartis PharmaceuticalsCompletedSevere Pulmonary Arterial HypertensionJapan
-
Amsterdam UMC, location VUmcZonMw: The Netherlands Organisation for Health Research and DevelopmentUnknown
-
Association de Recherche en Physiopathologie RespiratoireGlaxoSmithKline; Soladis; InterlisUnknownPulmonary Arterial Hypertension (PAH)France
-
Medical University of GrazLudwig Boltzmann Institute for Lung Vascular ResearchCompletedIdiopathic Pulmonary Arterial HypertensionAustria
Clinical Trials on Telmisartan (Kinzal/Pritor, BAY68-9291)
-
BayerCompleted
-
BayerBang & Olufsen MedicomCompletedHypertensionPoland, Slovakia
-
BayerCompleted
-
BayerCompleted
-
BayerCompleted
-
BayerCompletedHypertensionPoland, Slovakia, Croatia, Slovenia
-
DongKoo Bio & PharmaUnknownHyperlipidemia, HypertriglyceridemiaKorea, Republic of
-
BayerCompleted
-
Boehringer IngelheimCompleted