NCT02245464

Brief Summary

The objective of this PMS study was to monitor and assess the safety of Micardis tablets in patients with hypertension over a period of 6 years

Trial Health

100
On Track

Trial Health Score

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

Enrollment
13,066

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

November 1, 2000

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
7.9 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 19, 2014

Completed
Last Updated

September 19, 2014

Status Verified

September 1, 2014

Enrollment Period

6 years

First QC Date

September 18, 2014

Last Update Submit

September 18, 2014

Conditions

Hypertension

Outcome Measures

Primary Outcomes (6)

  • Blood pressure reduction

    Up to 6 years

  • Final assessment of efficacy on a 3-point scale

    Up to 6 years

  • Assessment of efficacy based on subject's demographics on a two-point scale

    Up to 6 years

  • Number of patients with adverse events

    Up to 6 years

  • Incidence rate of adverse events

    based on demographic factors

    Up to 6 years

  • Assessment of safety on a 4-point scale

    based on adverse events and changes in abnormality of clinical laboratory tests

    Up to 6 years

Study Arms (1)

Patients with essential hypertension

Drug: Telmisartan

Interventions

TelmisartanDRUG
Patients with essential hypertension

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with essential hypertension and without prior Micardis experience

You may qualify if:

  • Male and female patients diagnosed with essential hypertension
  • Patients without prior experience with Micardis tablet

You may not qualify if:

  • Known hypersensitivity to Micardis tablet
  • Pregnancy or breastfeeding
  • Biliary atresia
  • Severe hepatic failure patients
  • Severe renal failure patients

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 18, 2014

First Posted

September 19, 2014

Study Start

November 1, 2000

Primary Completion

November 1, 2006

Last Updated

September 19, 2014

Record last verified: 2014-09