NCT02242331

Brief Summary

This post-marketing surveillance study is designed to supplement under conditions of normal clinical practice data on safety, tolerability and efficacy of Micardis® collected in clinical studies with special emphasis on the control of blood pressure in the morning before intake of the next antihypertensive drug

Trial Health

100
On Track

Trial Health Score

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

Enrollment
19,805

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

June 1, 2001

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2002

Completed
12.4 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

11 months

First QC Date

September 16, 2014

Last Update Submit

September 16, 2014

Conditions

Hypertension

Outcome Measures

Primary Outcomes (3)

  • Change from baseline in blood pressure

    with special emphasis on the morning blood pressure, before intake of the next antihypertensive treatment

    Baseline, after 3 months

  • Number of patients with adverse events

    up to 3 months

  • Changes from baseline in pulse rate

    Baseline, after 3 months

Secondary Outcomes (2)

  • Assessment of efficacy by investigator on 5- point scale

    after 3 months

  • Assessment of tolerability by investigator on a 5-point scale

    after 3 months

Study Arms (1)

essential hypertension patients

Drug: Micardis®

Interventions

Micardis®DRUG
essential hypertension patients

Eligibility Criteria

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

Patients with diagnosis of essential hypertension recruited at general practitioners and specialists in internal medicine in non-hospital practice

You may qualify if:

  • Essential hypertension
  • At least 18 years of age

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

June 1, 2001

Primary Completion

May 1, 2002

Last Updated

September 17, 2014

Record last verified: 2014-09