NCT00573742

Brief Summary

The purpose of this study is to observe treatment with candesartan cilexetil 16mg for 8 weeks, in uncontrolled hypertensive patients, in improvement of achieving of treatment goals and impact on blood pressure level in patients with uncontrolled hypertension treated with candesartan cilexetil.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,940

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2007

Shorter than P25 for all trials

Geographic Reach
1 country

16 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

Study Start

First participant enrolled

September 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 14, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

August 19, 2010

Status Verified

August 1, 2010

Enrollment Period

5 months

First QC Date

December 13, 2007

Last Update Submit

August 18, 2010

Conditions

Keywords

hypertension

Interventions

Eligibility Criteria

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

hypertensive patients not at BP target (according to ESC Guideline for the management of hypertension, 2003), already treated with candesartan cilexetil 16 mg/day

You may qualify if:

  • diagnosis of essential hypertension (mild or moderate as defined in European Guidelines of Hypertension, 2003), that are treated already with candesartan cilexetil 16mg o.d. within last 2 weeks or more, according to Romanian approved Atacand SPC. Written informed consent to allow access and use(analysis) of data collected

You may not qualify if:

  • Patients not to be included in the programme: patients who have any contraindication to the product as detailed in Romanian approved Atacand SPC. Use of specific concomitant medication known to present a potential safety concern according to Romanian approved SPC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Research Site

Bacau, Romania

Location

Research Site

Brasov, Romania

Location

Research Site

Brăila, Romania

Location

Research Site

Bucharest, Romania

Location

Research Site

Cluj-Napoca, Romania

Location

Research Site

Constanța, Romania

Location

Research Site

Craiova, Romania

Location

Research Site

Galati, Romania

Location

Research Site

Ghiroda, Romania

Location

Research Site

Iași, Romania

Location

Research Site

Lugoj, Romania

Location

Research Site

Oradea, Romania

Location

Research Site

Piteşti, Romania

Location

Research Site

Ploieşti, Romania

Location

Research Site

Sibiu, Romania

Location

Research Site

Timișoara, Romania

Location

MeSH Terms

Conditions

Essential HypertensionHypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Mihai Isvoranu

    AstraZeneca

    STUDY CHAIR
  • Gabriela Teodorescu

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 13, 2007

First Posted

December 14, 2007

Study Start

September 1, 2007

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

August 19, 2010

Record last verified: 2010-08

Locations