NCT02242838

Brief Summary

The primary objective of this survey is to prospectively investigate safety and efficacy in patients with hypertension treated with telmisartan in proper use in medical practice over a long period

Trial Health

100
On Track

Trial Health Score

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

Enrollment
6,336

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
8 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

3 years

First QC Date

September 16, 2014

Last Update Submit

September 16, 2014

Conditions

Hypertension

Outcome Measures

Primary Outcomes (4)

  • Number of patients with adverse drug reactions

    up to 1 year

  • Incidence of adverse drug reactions

    classified by Medical Dictionary for Regulatory Activities (MedDRA) terminology

    up to 1 year

  • Change in Mean systolic blood pressure (SBP)

    up to 1 year

  • Change in Mean diastolic blood pressure (DBP)

    up to 1 year

Secondary Outcomes (2)

  • Overall assessment of efficacy by investigator on 4-point scale

    at 3 month, after 1 year

  • Change in pulse rate

    up to 1 year

Study Arms (1)

Hypertensive patients

Drug: Telmisartan

Interventions

TelmisartanDRUG
Also known as: Micardis®
Hypertensive patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hypertension patients without telmisartan treatment are selected at medical institutions

You may qualify if:

  • Patients with hypertension

You may not qualify if:

  • Patients with the following conditions
  • Patients with a history of hypersensitivity of this product
  • Women in pregnancy (included the possibility of pregnancy)
  • Patients with severe biliary obstructive disorders or severe hepatic insufficiency

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, 2003

Primary Completion

September 1, 2006

Last Updated

September 17, 2014

Record last verified: 2014-09