NCT02243566

Brief Summary

The purpose of the study was to examine the effect of six- to eight-week treatment with MicardisPlus® on blood pressure and the effect of patient self-monitoring on blood pressure control. In addition, the post-marketing surveillance study offered the possibility to obtain information about the influence on different laboratory parameters during treatment with MicardisPlus® from an unselected patient group under office conditions

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2,707

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

April 1, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
7.7 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 18, 2014

Completed
Last Updated

September 18, 2014

Status Verified

September 1, 2014

Enrollment Period

9 months

First QC Date

September 16, 2014

Last Update Submit

September 16, 2014

Conditions

Hypertension

Outcome Measures

Primary Outcomes (6)

  • Changes in morning blood pressure (systolic and diastolic)

    Pre-dose, up to 8 weeks after start of treatment

  • Changes from baseline in laboratory values

    Pre-dose, up to 8 weeks after start of treatment

  • Investigator assessment of efficacy on a 5-point scale

    Up to 8 weeks after start of treatment

  • Investigator assessment of influence on metabolism on a 3-point scale

    Up to 8 weeks after start of treatment

  • Investigator assessment of tolerability on a 5-point scale

    Up to 8 weeks after start of treatment

  • Number of patients with adverse events

    Up to 8 weeks

Study Arms (1)

Essential hypertension

Drug: MicardisPlus®

Interventions

MicardisPlus®DRUG
Also known as: Telmisartan in combination with hydrochlorothiazide
Essential hypertension

Eligibility Criteria

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

Outpatients with essential hypertension

You may qualify if:

  • Age \> 18 years
  • Hypertension

You may not qualify if:

  • Age \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Interventions

telmisartan, hydrochlorothiazide drug combinationTelmisartanHydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsThiazides

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 18, 2014

Study Start

April 1, 2006

Primary Completion

January 1, 2007

Last Updated

September 18, 2014

Record last verified: 2014-09