NCT02176850

Brief Summary

This post-marketing surveillance study was designed to supplement under conditions of normal clinical practice the data on the safety, tolerability and efficacy of Micardis® collected during the clinical studies.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
19,870

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

January 1, 1999

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2000

Completed
14.2 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2014

Completed
Last Updated

July 8, 2014

Status Verified

July 1, 2014

Enrollment Period

1.3 years

First QC Date

June 25, 2014

Last Update Submit

July 7, 2014

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

  • Indicence of ulcera

    Up to 6 months after start of study

  • Incidence of gastrointestinal (GI) bleedings

    Up to 6 months after start of study

Secondary Outcomes (3)

  • Incidence of adverse events (GI-complaints inclusive)

    Up to 6 months after start of study

  • Change from baseline in office blood pressure

    Up to 6 months after start of study

  • Response rate

    Up to 6 months after start of study

Study Arms (1)

Micardis®

Drug: Micardis®

Interventions

Micardis®DRUG
Micardis®

Eligibility Criteria

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

Patients of general practioners, cardiologists and specialist in internal medicine in non-hospital practice

You may qualify if:

  • Patients of both sexes with essential hypertension and a minimum age of 18 years

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

June 25, 2014

First Posted

June 27, 2014

Study Start

January 1, 1999

Primary Completion

May 1, 2000

Last Updated

July 8, 2014

Record last verified: 2014-07