NCT02262611

Brief Summary

Study to obtain long-term data on effects, safety and tolerability in routine medical practice and to investigate the potential of telmisartan to prevent secondary organ damage

Trial Health

100
On Track

Trial Health Score

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

Enrollment
266

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, 2003

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
8.9 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 13, 2014

Completed
Last Updated

October 13, 2014

Status Verified

October 1, 2014

Enrollment Period

2.9 years

First QC Date

October 10, 2014

Last Update Submit

October 10, 2014

Conditions

Hypertension

Outcome Measures

Primary Outcomes (5)

  • Number of patients with adverse events

    up to 1 year

  • Number of patients with abnormal changes in laboratory parameters

    up to 1 year

  • Number of patients with clinically significant changes in vital signs

    up to 1 year

  • Change in systolic blood pressure

    up to 1 year

  • Change in diastolic blood pressure

    up to 1 year

Secondary Outcomes (2)

  • Global assessment of efficacy by investigator on a 4-point scale

    2 weeks, after 1 year

  • Global assessment of tolerability by investigator on a 4-point scale

    2 weeks, after 1 year

Study Arms (4)

Hypertension patients - Pneumology

Drug: Micardis®Drug: MicardisPlus®

Hypertension patients - Cardiology

Drug: Micardis®Drug: MicardisPlus®

Hypertension patients - Nephrology

Drug: Micardis®Drug: MicardisPlus®

Hypertension patients - Diabetology

Drug: Micardis®Drug: MicardisPlus®

Interventions

Micardis®DRUG
Hypertension patients - CardiologyHypertension patients - DiabetologyHypertension patients - NephrologyHypertension patients - Pneumology
MicardisPlus®DRUG
Hypertension patients - CardiologyHypertension patients - DiabetologyHypertension patients - NephrologyHypertension patients - Pneumology

Eligibility Criteria

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

Patients with hypertension recruited at hospitals in Germany specialized in cardiology, nephrology, diabetology and pneumology

You may qualify if:

  • Adult patients of both gender aged \>=18 admitted to a hospital due to insufficiently controlled essential hypertension.
  • No additional selection criteria have to be considered. Treatment was at the discretion of the physician following the summary of product information for Micardis® and MicardisPlus®

You may not qualify if:

  • not applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Interventions

Telmisartantelmisartan, hydrochlorothiazide drug combination

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

October 10, 2014

First Posted

October 13, 2014

Study Start

January 1, 2003

Primary Completion

December 1, 2005

Last Updated

October 13, 2014

Record last verified: 2014-10