NCT02238275

Brief Summary

Study to evaluate efficacy and tolerability of Micardis® plus under usual daily-practice prescribing-conditions

Trial Health

100
On Track

Trial Health Score

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

Enrollment
8,135

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, 2002

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2002

Completed
11.8 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2014

Completed
Last Updated

September 12, 2014

Status Verified

September 1, 2014

Enrollment Period

6 months

First QC Date

September 11, 2014

Last Update Submit

September 11, 2014

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in morning blood pressure

    Baseline, after 6 weeks

  • Change from baseline in classification of blood pressure

    according to Word Health Organisation - Isolated systolic hypertension (WHO-ISH) - definition of 'Deutsche Hochdruckliga'

    Baseline, after 6 weeks

Secondary Outcomes (4)

  • Number of patients with adverse drug reactions

    up to 6 weeks

  • Assessment of efficacy by investigator on 5-point scale

    after 6 weeks

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

    after 6 weeks

  • Change from baseline in heart rate

    Baseline, after 6 weeks

Study Arms (1)

Patients with hypertension

Drug: Micardis® plus

Interventions

Micardis® plusDRUG
Patients with hypertension

Eligibility Criteria

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

Outpatients with hypertension

You may qualify if:

  • Adult (Age \>= 18 years) males and females for whom a medical antihypertensive therapy is indicated

You may not qualify if:

  • Age \< 18 years

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 11, 2014

First Posted

September 12, 2014

Study Start

June 1, 2002

Primary Completion

December 1, 2002

Last Updated

September 12, 2014

Record last verified: 2014-09