NCT00471003

Brief Summary

The main purpose of this study is to asses the efficacy and safety of telmisartan, with the special attention on the influence of telmisartan on selected metabolic parameters of patients.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
5,448

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2006

Typical duration for all trials

Geographic Reach
3 countries

3 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, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 8, 2007

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

January 20, 2010

Status Verified

January 1, 2010

Enrollment Period

3.2 years

First QC Date

May 7, 2007

Last Update Submit

January 19, 2010

Conditions

Hypertension

Keywords

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Efficacy and safety of the treatment with telmisartan reported by the physician

    At the both of planned control visits. (Approx. interval between visits 3 months)

Secondary Outcomes (1)

  • Changes in metabolic parameters in telmisartan treated patients

    At the both of planned control visits. (Approx. interval between visits 3 months)

Study Arms (1)

Arm 1

Drug: Pritor (Telmisartan , BAY68-9291)

Interventions

Pritor (Telmisartan , BAY68-9291)DRUG

Primary care hypertensive patients starting the therapy with Telmisartan

Arm 1

Eligibility Criteria

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

Primary care clinic

You may qualify if:

  • Age over 18
  • Untreated or ineffectively treated arterial hypertension

You may not qualify if:

  • Cholestatic disorders and severe hepatic failure
  • Allergy to telmisartan
  • Pregnancy and lactation period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Many Locations, Croatia

Location

Unknown Facility

Many Locations, Poland

Location

Unknown Facility

Many Locations, Slovakia

Location

Unknown Facility

Many Locations, Slovenia

Location

MeSH Terms

Conditions

Hypertension

Interventions

Telmisartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 7, 2007

First Posted

May 8, 2007

Study Start

September 1, 2006

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

January 20, 2010

Record last verified: 2010-01

Locations

CR(1)SL(1)PL(1)