NCT02200575

Brief Summary

Study to confirm the safety profile of telmisartan (benefit-risk ratio) under normal conditions of use after market launch and to supplement the present data on the safety of telmisartan. Furthermore to assess effectiveness of a single dose of telmisartan per day to control blood pressure for 24 hours, especially during the last few hours of the dosage interval. Additionally to evaluate compliance with treatment, as an indirect measurement, and to confirm the efficacy and possible risks associated with treatment.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
10,333

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

May 1, 1999

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2000

Completed
13.7 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 25, 2014

Completed
Last Updated

July 25, 2014

Status Verified

July 1, 2014

Enrollment Period

1.6 years

First QC Date

July 24, 2014

Last Update Submit

July 24, 2014

Conditions

Hypertension

Outcome Measures

Primary Outcomes (3)

  • Assessment of changes in heart rate

    Baseline, up to 8 weeks after start of treatment

  • Assessment for patients with changes in laboratory values

    Baseline, up to 8 weeks after start of treatment

  • Number of patients with adverse events

    Up to 8 weeks after start of treatment

Secondary Outcomes (3)

  • Changes in mean systolic and diastolic blood pressure values

    Baseline, up to 8 weeks after start of treatment

  • Changes in mean systolic and diastolic blood pressure values

    Baseline, up to 8 weeks after start of treatment

  • Evaluation of treatment compliance as percentage of tablets planned

    Up to 8 weeks after start of treatment

Study Arms (1)

Patients with non-secondary, essential hypertension

Drug: Telmisartan

Interventions

TelmisartanDRUG
Also known as: Micardis®
Patients with non-secondary, essential hypertension

Eligibility Criteria

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

Outpatients over 18 years of age suffering non-secondary, essential hypertension, treated by general practitioners and/or specialists

You may qualify if:

  • \- Patients of either sex over the age of 18 years suffering from non-secondary essential hypertension with values of at least 90 mmHg (diastolic) and 140 mmHg (systolic)

You may not qualify if:

  • \- corresponding to the contraindications listed in the summary of product characteristics of the drug

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

July 24, 2014

First Posted

July 25, 2014

Study Start

May 1, 1999

Primary Completion

December 1, 2000

Last Updated

July 25, 2014

Record last verified: 2014-07