An Epidemiological Study to Evaluate Standard Daily Practice in Managing Patients With Arterial Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01201980
First received: September 14, 2010
Last updated: January 9, 2012
Last verified: January 2012
  Purpose

This study is aimed to evaluate response rate of the antihypertensive treatment with a calcium antagonist in real life practice, to evaluate patients' quality of life and to collect the following Serbia-specific epidemiology data on hypertension: demographic data, patents characteristics, and patients' management/treatment.


Condition
Hypertension

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: An Epidemiological Study to Evaluate Standard Daily Practice in Managing Patients With Arterial Hypertension and to Evaluate Patients' Quality of Life

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To evaluate proportion of patients on antihypertensive pharmacological treatment reaching SBP goals according to the ESC 2007 guidelines (<140 mmHg*). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate proportion of patients on antihypertensive pharmacological treatment reaching DBP goals according to the ESC 2007 guidelines (<90 mmHg*). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • To collect local epidemiological date on patients with hypertension (demographic data; hypertension management data: treatment, treatment changes and tolerability data). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • To evaluate patients quality of life after 12 and 24 weeks by using patients quality of life questionnaire [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 300
Study Start Date: December 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Subject population with essential arterial hypertension currently receiving treatment with a calcium antagonist

  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

Speciality care clinics

Criteria

Inclusion Criteria:

  • Subject population with essential arterial hypertension currently receiving treatment with a calcium antagonist
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01201980

Locations
Serbia
Research Site
Belgrade, Serbia
Research Site
Cacak, Serbia
Research Site
Kragujevac, Serbia
Research Site
Nis, Serbia
Research Site
Niska Banja, Serbia
Research Site
Pancevo, Serbia
Research Site
Sabac, Serbia
Research Site
Sremska Kamenica, Serbia
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: prof. dr Zorana Vasiljevic Clinical Center of Serbia, Belgrade
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01201980     History of Changes
Other Study ID Numbers: NIS-CRS-DUM-2010/2
Study First Received: September 14, 2010
Last Updated: January 9, 2012
Health Authority: Serbia: Ethics Committee

Keywords provided by AstraZeneca:
essential arterial hypertension
calcium antagonist

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Calcium Channel Blockers
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014