NCT00927537

Brief Summary

The efficacy and tolerability of an antihypertensive treatment with Telmisartan is followed over 3-4 months

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,052

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

April 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 25, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

September 4, 2013

Status Verified

September 1, 2013

Enrollment Period

3.5 years

First QC Date

June 24, 2009

Last Update Submit

September 1, 2013

Conditions

Hypertension

Keywords

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Blood pressure

    After 1-2 weeks, 1month, 3-4 months

Secondary Outcomes (5)

  • Change in Mean heart rate (bpm)

    Baseline and 3-4 month

  • Change in Mean Weight (kg)

    Baseline and 3-4 month

  • Change in Mean laboratory parameters (total cholesterol, LDL, HDL, triglyceride, fasting blood glucose)

    Baseline and 3-4 month

  • Patient Medical History: Duration of hypertension, Pre-treatment of hypertension, Comorbidities and Concomitant treatment

    Baseline

  • Final evaluation of efficacy (very good, good, sufficient, insufficient) and tolerability (very good, good, sufficient, insufficient) of treatment by the physician.

    After 3-4 month

Study Arms (2)

Group 1

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

Group 2

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

Interventions

Telmisartan (Kinzal/Pritor, BAY68-9291)DRUG

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

Group 1
Telmisartan (Kinzal/Pritor, BAY68-9291) + HydrochlorothiazideDRUG

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

Group 2

Eligibility Criteria

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

Community

You may qualify if:

  • Hypertensive patients seen by the physician requiring antihypertensive treatment

You may not qualify if:

  • According to the local drug information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, Switzerland

Location

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 Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2009

First Posted

June 25, 2009

Study Start

April 1, 2008

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

September 4, 2013

Record last verified: 2013-09

Locations

CH(1)