NCT00932867

Brief Summary

Surveillance of efficacy and safety of drug PRITOR in patieNts with arterial hypertension, who do not tolerate ACE inhibitoR treatment

Trial Health

90
On Track

Trial Health Score

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

Enrollment
3,114

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2007

Geographic Reach
2 countries

2 active sites

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

December 1, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 3, 2009

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

April 20, 2010

Status Verified

April 1, 2010

Enrollment Period

6 months

First QC Date

July 2, 2009

Last Update Submit

April 19, 2010

Conditions

Hypertension

Keywords

Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

  • To evaluate efficacy and safety of telmisartan in patients with arterial hypertension, who do not tolerate ACEI treatment

    1 year

Study Arms (1)

Group 1

Drug: Kinzal/Pritor (Telmisartan, BAY68-9291)

Interventions

Kinzal/Pritor (Telmisartan, BAY68-9291)DRUG

Patients under daily life treatment receiving Pritor according to local drug information.

Group 1

Eligibility Criteria

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

* Any patient with a diagnosis of arterial hypertension, who do not tolerated ACE inhibitor treatment treated by the drug PRITOR * Exclusion criteria for the patients treated by the drug PRITOR must be read in conjunction with the local product information

You may qualify if:

  • Patients over 18 years of age
  • Arterial hypertension (SBP \< 160 mmHg and DBP \< 100 mmHg)
  • Patients, who do not tolerate ACE inhibitors (must be documented in the official ambulant documentation)
  • Patients over 18 years of age
  • Arterial hypertension (SBP \< 160 mmHg and DBP \< 100 mmHg)
  • Patients, who tolerate ACEi treatment

You may not qualify if:

  • Cholestasis, severe hepatic insufficiency
  • Allergy to telmisartan
  • Gravidity or lactation
  • Cholestasis, severe hepatic insufficiency
  • Allergy to ACEi
  • Gravidity or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Many Locations, Romania

Location

Unknown Facility

Many Location, Slovakia

Location

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 Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 2, 2009

First Posted

July 3, 2009

Study Start

December 1, 2007

Primary Completion

June 1, 2008

Study Completion

August 1, 2009

Last Updated

April 20, 2010

Record last verified: 2010-04

Locations

SL(1)RO(1)