NCT00470886

Brief Summary

The purpose of this study is to asses the efficacy and safety of Telmisartan depending on the use of an electronic therapy monitoring device (HelpingHand) in a real life setting and to asses patients compliance to the therapy with Telmisartan in relation to use of electronic therapy monitoring device.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
3,400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2007

Typical duration for all trials

Geographic Reach
2 countries

2 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

April 1, 2007

Completed
1 month 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
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

November 16, 2012

Status Verified

November 1, 2012

Enrollment Period

2.8 years

First QC Date

May 7, 2007

Last Update Submit

November 14, 2012

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Efficacy and safety of the treatment with telmisartan reported by the physician with regard to usage the HelpingHand device

    At all four planned control visits. (Approx. interval between visits 3 months)

Secondary Outcomes (1)

  • Compliance with the treatment calculated on the basis of by HelpingHand and patients questionnaires

    At all four planned control visits. (Approx. interval between visits 3 months)

Study Arms (1)

Group 1

Drug: Telmisartan (Kinzal/Pritor, BAY68-9291)

Interventions

Telmisartan (Kinzal/Pritor, BAY68-9291)DRUG

Primary care clinic hypertensive patients for whom physician decided to start the treatment with telmisartan

Group 1

Eligibility Criteria

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

Primary care clinic hypertensive patients for whom physician decided to start the treatment with telmisartan

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
  • Unwillingness to participate in the study
  • Inability to use the drug reminder device
  • Unwillingness to use the drug reminder device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Many Locations, Poland

Location

Unknown Facility

Many Locations, Slovakia

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

April 1, 2007

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

November 16, 2012

Record last verified: 2012-11

Locations

PL(1)SL(1)