Therapy of Essential Hypertension With Kinzal®/ Kinzalplus®

September 1, 2013 updated by: Bayer

Data Collection on Hypertension and Its Treatment With Kinzal®/ Kinzalplus®

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2052

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Community

Description

Inclusion Criteria:

  • Hypertensive patients seen by the physician requiring antihypertensive treatment

Exclusion Criteria:

  • According to the local drug information

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: Telmisartan (Kinzal/Pritor, BAY68-9291)
Patients under daily life treatment receiving Kinzal according to local drug information.
Group 2
Drug: Telmisartan (Kinzal/Pritor, BAY68-9291) + Hydrochlorothiazide
Patients under daily life treatment receiving Kinzalplus according to local drug information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood pressure
Time Frame: After 1-2 weeks, 1month, 3-4 months
After 1-2 weeks, 1month, 3-4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Mean heart rate (bpm)
Time Frame: Baseline and 3-4 month
Baseline and 3-4 month
Change in Mean Weight (kg)
Time Frame: Baseline and 3-4 month
Baseline and 3-4 month
Change in Mean laboratory parameters (total cholesterol, LDL, HDL, triglyceride, fasting blood glucose)
Time Frame: Baseline and 3-4 month
Baseline and 3-4 month
Patient Medical History: Duration of hypertension, Pre-treatment of hypertension, Comorbidities and Concomitant treatment
Time Frame: Baseline
Baseline
Final evaluation of efficacy (very good, good, sufficient, insufficient) and tolerability (very good, good, sufficient, insufficient) of treatment by the physician.
Time Frame: After 3-4 month
After 3-4 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

June 24, 2009

First Submitted That Met QC Criteria

June 24, 2009

First Posted (Estimate)

June 25, 2009

Study Record Updates

Last Update Posted (Estimate)

September 4, 2013

Last Update Submitted That Met QC Criteria

September 1, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13599
  • KL0810CH (Other Identifier: company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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