NCT01201980

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2010

Shorter than P25 for all trials

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 15, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 10, 2012

Status Verified

January 1, 2012

Enrollment Period

1 year

First QC Date

September 14, 2010

Last Update Submit

January 9, 2012

Conditions

Hypertension

Keywords

essential arterial hypertensioncalcium antagonist

Outcome Measures

Primary Outcomes (1)

  • To evaluate proportion of patients on antihypertensive pharmacological treatment reaching SBP goals according to the ESC 2007 guidelines (<140 mmHg*).

    24 weeks

Secondary Outcomes (3)

  • To evaluate proportion of patients on antihypertensive pharmacological treatment reaching DBP goals according to the ESC 2007 guidelines (<90 mmHg*).

    24 weeks

  • To collect local epidemiological date on patients with hypertension (demographic data; hypertension management data: treatment, treatment changes and tolerability data).

    24 weeks

  • To evaluate patients quality of life after 12 and 24 weeks by using patients quality of life questionnaire

    24 weeks

Study Arms (1)

1

Subject population with essential arterial hypertension currently receiving treatment with a calcium antagonist

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Speciality care clinics

You may qualify if:

  • Subject population with essential arterial hypertension currently receiving treatment with a calcium antagonist

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Research Site

Belgrade, Serbia

Location

Research Site

Čačak, Serbia

Location

Research Site

Kamenitz, Serbia

Location

Research Site

Kragujevac, Serbia

Location

Research Site

Niš, Serbia

Location

Research Site

Niška Banja, Serbia

Location

Research Site

Pančevo, Serbia

Location

Research Site

Šabac, Serbia

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • prof. dr Zorana Vasiljevic

    Clinical Center of Serbia, Belgrade

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2010

First Posted

September 15, 2010

Study Start

December 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

January 10, 2012

Record last verified: 2012-01

Locations

SE(8)