An Observational Study to Investigate the Efficacy, Safety, Tolerability and the Effect on Quality of Life of Telmisartan (Micardis) and Telmisartan With HCTZ (Micardis Plus) in Patients With Hypertension

April 3, 2014 updated by: Boehringer Ingelheim

A Post Marketing Observational Study to Investigate the Efficacy, Safety, Tolerability and the Effect on Quality of Life of Telmisartan (Micardis) and Telmisartan With HCTZ (Micardis Plus) in Patients With Hypertension

An observational study to investigate the efficacy, safety, tolerability and the effect on quality of life of Telmisartan (Micardis) and Telmisartan with HCTZ (Micardis Plus) in patients with hypertension

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1095

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

  • Korea, Republic of
      • Daegu, Korea, Republic of
        • Boehringer Ingelheim Investigational Site 1
      • Daegu, Korea, Republic of
        • Boehringer Ingelheim Investigational Site 4
      • Daegu, Korea, Republic of
        • Boehringer Ingelheim Investigational Site 7
      • Daejeon, Korea, Republic of
        • Boehringer Ingelheim Investigational Site 9
      • Koyang, Korea, Republic of
        • Boehringer Ingelheim Investigational Site 10
      • Kwangju, Korea, Republic of
        • Boehringer Ingelheim Investigational Site 11
      • Kwangju, Korea, Republic of
        • Boehringer Ingelheim Investigational Site 3
      • Pusan, Korea, Republic of
        • Boehringer Ingelheim Investigational Site 5
      • Seoul, Korea, Republic of
        • Boehringer Ingelheim Investigational Site 2
      • Suwon, Korea, Republic of
        • Boehringer Ingelheim Investigational Site 6
      • Wonju, Korea, Republic of
        • Boehringer Ingelheim Investigational Site 8

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 to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients from clinics and hospitals in Korea

Description

Inclusion Criteria:

  1. Ability to provide written/verbal informed consent in accordance with GCP (Good Clinical Practice) and local legislation
  2. Patients aged 18 ~ under 80

  3. Hypertension as described below:

    • Newly diagnosed patients with hypertension
    • Patients with current antihypertensive therapy

Exclusion Criteria:

  1. Female subjects who are breastfeeding, pregnant or who plan to be pregnant during the study
  2. Known or suspected secondary hypertension(e.g. pheochromocytoma)
  3. Patients who have been treated with telmisartan prior to the acquisition of informed consent (including verbal informed consent)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in SBP (Systolic Blood Pressure)
Time Frame: between baseline (visit 1) and after 12 weeks of treatment (visit 3)
The change of the mean SBP
between baseline (visit 1) and after 12 weeks of treatment (visit 3)
Change in DBP (Diastolic Blood Pressure)
Time Frame: between baseline (visit 1) and after 12 weeks of treatment (visit 3)
The change of the mean DBP
between baseline (visit 1) and after 12 weeks of treatment (visit 3)
Change in WHO-QOL (WHO-Quality Of Life)
Time Frame: between baseline (visit 1) and after 12 weeks of treatment (visit 3)

World Health Organization-Quality Of Life (WHO-QOL), change in quality of life was assessed.

Best value=130.0 (highest quality of life), worst value=0.0 (lowest quality of life)
between baseline (visit 1) and after 12 weeks of treatment (visit 3)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in VAS (Visual Analog Scale)
Time Frame: between baseline (visit 1) and after 12 weeks of treatment (visit 3)
VAS indicates the health status of the patient. Best value=100.0 (best health status), worst value=0.0 (worst health status)
between baseline (visit 1) and after 12 weeks of treatment (visit 3)

Collaborators and Investigators

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

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

February 1, 2005

Primary Completion (ACTUAL)

May 1, 2007

Study Registration Dates

First Submitted

May 18, 2009

First Submitted That Met QC Criteria

May 18, 2009

First Posted (ESTIMATE)

May 19, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

April 21, 2014

Last Update Submitted That Met QC Criteria

April 3, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 502.487

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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