NCT02242383

Brief Summary

To evaluate efficacy and tolerability of Micardis® / MicardisPlus® under usual daily-practice prescribing conditions with a special emphasis on controlling morning blood pressure

Trial Health

100
On Track

Trial Health Score

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

Enrollment
13,248

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

January 1, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
9 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

9 months

First QC Date

September 16, 2014

Last Update Submit

September 16, 2014

Conditions

Hypertension

Outcome Measures

Primary Outcomes (8)

  • Changes in morning blood pressure (BP)

    Pre-dose, up to 6 months after start of treatment

  • Changes in metabolic laboratory parameters

    Pre-dose, up to 6 months after start of treatment

  • Changes in morning blood pressure in patients with or without telemonitoring (TM) of BP

    Pre-dose, up to 6 months after start of treatment

  • Investigator assessment of efficacy in reducing morning hypertension on a 5-point rating scale

    Up to 6 months after start of treatment

  • Investigator assessment of effects on metabolism on a 3-point rating scale

    Up to 6 months after start of treatment

  • Investigator assessment of tolerability on a 5-point rating scale

    Up to 6 months after start of treatment

  • Number of patients with adverse events

    Up to 6 months

  • Changes in morning heart rate

    Pre-dose, up to 6 months after start of treatment

Study Arms (1)

Essential hypertension

Drug: TelmisartanDrug: Telmisartan in combination with hydrochlorothiazide

Interventions

TelmisartanDRUG
Essential hypertension
Telmisartan in combination with hydrochlorothiazideDRUG
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, insufficiently treated hypertension

You may not qualify if:

  • \- Age \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Interventions

TelmisartanHydrochlorothiazide

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 17, 2014

Study Start

January 1, 2005

Primary Completion

October 1, 2005

Last Updated

September 17, 2014

Record last verified: 2014-09