NCT02242851

Brief Summary

Primary objective: to characterize hypertensive patients treated for at least 1 month with Telmisartan (alone or in combination with other drugs) in order to define the beneficiary population (those actually receiving the treatment). Secondary objectives:

  • to describe the patients' blood pressure values (when self-monitored) and satisfaction with the treatment (ease of use, efficacy, safety) on the basis of a patient self-questionnaire, filled out 4 weeks after consultation.
  • to compare the characteristics of the beneficiary population to those of the initial target population defined in the SPC (summary of product characteristics) for Telmisartan

Trial Health

100
On Track

Trial Health Score

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

Enrollment
5,018

participants targeted

Target at P75+ for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
9.4 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 17, 2014

Completed
Last Updated

September 17, 2014

Status Verified

September 1, 2014

Enrollment Period

8 months

First QC Date

September 16, 2014

Last Update Submit

September 16, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Characteristics of hypertensive patients

    Questionnaire to determine the beneficiary population

    Baseline, after 1 month of treatment

Secondary Outcomes (2)

  • Changes in blood pressure

    Up to 1 month

  • Evaluation of patients satisfaction with treatment

    Up to 1 month

Study Arms (1)

Hypertensive patients

Drug: Telmisartan

Interventions

Hypertensive patients

Eligibility Criteria

Age21 Years - 94 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hypertensive patients treated with Telmisartan for at least one month recruited by ceneral practitioners and cardiologists

You may qualify if:

  • Hypertensive patients treated with Telmisartan for at least one month, consulting a medical practitioner (for whatever reason)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2014

First Posted

September 17, 2014

Study Start

September 1, 2004

Primary Completion

May 1, 2005

Last Updated

September 17, 2014

Record last verified: 2014-09