Evaluation of the Effect of Telmisartan on Blood Pressure Control of High Risk Patients

February 28, 2014 updated by: Boehringer Ingelheim

Evaluation of the Effect of Telmisartan (Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg) on Blood Pressure and Cardiovascular Risk Factor Index in High Risk Hypertensive Patients

The study is designed to evaluate the effect of treatment with Micardis/MicardisPlus on blood pressure and its ability to reduce different indicated cardiovascular risk scores. The study will also evaluate the current antihypertensive treatment pattern in the daily practice among the patient population at increased cardiovascular risk.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

295

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

  • Romania
      • Arad, Romania
        • Boehringer Ingelheim Investigational Site 1
      • Bacau, Romania
        • Boehringer Ingelheim Investigational Site 5
      • Baia Mare, Romania
        • Boehringer Ingelheim Investigational Site 6
      • Braila, Romania
        • Boehringer Ingelheim Investigational Site 8
      • Brasov, Romania
        • Boehringer Ingelheim Investigational Site 9
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 10
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 11
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 12
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 13
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 14
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 15
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 16
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 17
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 18
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 19
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 20
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 21
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 22
      • Buzau, Romania
        • Boehringer Ingelheim Investigational Site 23
      • Calarasi, Romania
        • Boehringer Ingelheim Investigational Site 24
      • Campulung, Romania
        • Boehringer Ingelheim Investigational Site 4
      • Carei, Romania
        • Boehringer Ingelheim Investigational Site 42
      • Cluj-Napoca, Romania
        • Boehringer Ingelheim Investigational Site 26
      • Cluj-Napoca, Romania
        • Boehringer Ingelheim Investigational Site 27
      • Cluj-Napoca, Romania
        • Boehringer Ingelheim Investigational Site 28
      • Constanta, Romania
        • Boehringer Ingelheim Investigational Site 29
      • Craiova, Romania
        • Boehringer Ingelheim Investigational Site 31
      • Curtea de Arges, Romania
        • Boehringer Ingelheim Investigational Site 2
      • Drobeta-Turnu Severin, Romania
        • Boehringer Ingelheim Investigational Site 38
      • Galati, Romania
        • Boehringer Ingelheim Investigational Site 32
      • Iasi, Romania
        • Boehringer Ingelheim Investigational Site 34
      • Iasi, Romania
        • Boehringer Ingelheim Investigational Site 35
      • Iasi, Romania
        • Boehringer Ingelheim Investigational Site 36
      • Iasi, Romania
        • Boehringer Ingelheim Investigational Site 37
      • Oradea, Romania
        • Boehringer Ingelheim Investigational Site 7
      • Pitesti, Romania
        • Boehringer Ingelheim Investigational Site 3
      • Ploiesti, Romania
        • Boehringer Ingelheim Investigational Site 40
      • Ploiesti, Romania
        • Boehringer Ingelheim Investigational Site 41
      • Ramnicu-Valcea, Romania
        • Boehringer Ingelheim Investigational Site 49
      • Resita, Romania
        • Boehringer Ingelheim Investigational Site 25
      • Slobozia, Romania
        • Boehringer Ingelheim Investigational Site 33
      • Suceava, Romania
        • Boehringer Ingelheim Investigational Site 43
      • Targoviste, Romania
        • Boehringer Ingelheim Investigational Site 30
      • Targu-Mures, Romania
        • Boehringer Ingelheim Investigational Site 39
      • Timisoara, Romania
        • Boehringer Ingelheim Investigational Site 44
      • Timisoara, Romania
        • Boehringer Ingelheim Investigational Site 45
      • Timisoara, Romania
        • Boehringer Ingelheim Investigational Site 46
      • Timisoara, Romania
        • Boehringer Ingelheim Investigational Site 47
      • Tulcea, Romania
        • Boehringer Ingelheim Investigational Site 48

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

Probability Sample

Study Population

Patients with arterial hypertension

Description

Inclusion criteria:

  • diagnosis of essential arterial hypertension (BP>140/90 mm HG or BP>130/80 mm Hg for diabetic patients)
  • at least one additional cardiovascular risk factor and/or known single or multiple end organ damage and/or previous cardiovascular disease

Exclusion criteria:

  • hypersensitivity to the active substance or to any of the excipients in any ACE inhibitor or angiotensin receptor blocker (ARB) available on the local market, as prescribed in the SPC
  • pregnancy and lactation
  • diseases involving biliary obstruction
  • severe liver impairment
  • severe hypertension
  • malignant hypertension
  • secondary hypertension
  • patients age under 18 years

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with arterial hypertension
Drug: Telmisartan or Telmisartan and Hydrochlorthiazide
Telmisartan 80mg +/- Hydrochlorthiazide 12.5mg or 25mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Systolic Blood Pressure From Baseline to Study End
Time Frame: From baseline to visit 3 (6 months)
From baseline to visit 3 (6 months)
Change in Diastolic Blood Pressure From Baseline to Study End
Time Frame: From baseline to visit 3 (6 months)
From baseline to visit 3 (6 months)
Evolution of the Cardiovascular Risk Factor SCORE From Baseline to Study End
Time Frame: From baseline to visit 3 (6 months)
A 10 year risk of fatal cardiovascular disease (CVD) in populations at high risk. Minimum 0 percent risk to Maximum 47 percent risk. Investigator judgement of evolution of SCORE from baseline to end of study. (Positive = reduction in CV risk; Neutral = no change in CV risk; Negative = deterioration in CV risk; Missing = no data available)
From baseline to visit 3 (6 months)
Evolution of the Cardiovascular Risk Factor Framingham From Baseline to Study End
Time Frame: From baseline to visit 3 (6 months)
10-year risk for hard coronary heart disease (CHD) outcomes (Myocardial Infarction and coronary death), according to Framingham Heart Study, measured in percent. Low risk (10 or less CHD risk at 10 years), intermediate risk (10-20), high risk (20 or more). Investigator judgement of evolution of Framingham risk score from baseline to end of study. (Positive = reduction in CV risk; Neutral = no change in CV risk; Negative = deterioration in CV risk; Missing = no data available)
From baseline to visit 3 (6 months)
Evolution of the European Society of Hypertension / European Society of Cardiology (ESH/ESC) Based Cardiovascular Risk Factor From Baseline to Study End
Time Frame: From baseline to visit 3 (6 months)
ESH is the European society of hypertension, and ESC is the European society of cardiology. Investigator judgement of evolution of CV risk based on ESH/ ESC criteria from baseline to end of study. (Positive = reduction in CV risk; Neutral = no change in CV risk; Negative = deterioration in CV risk; Missing = no data available)
From baseline to visit 3 (6 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients That Achieve Target Blood Pressure Values According to the European Society of Hypertension/European Society of Cardiology (ESH/ESC)
Time Frame: Visit 3 (6 months from baseline)
ESH/ESC a goal of treatment to be below values 130/80 mm/Hg for diabetic patients and below 140/90 mmHg for non-diabetic patients
Visit 3 (6 months from baseline)
Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study)
Time Frame: 6 Months
6 Months
Change in Heart Rate From Baseline to Study End
Time Frame: From baseline to visit 3 (6 months)
From baseline to visit 3 (6 months)
Number of Participants Not Completing Study
Time Frame: 3rd visit (6 months)
Number of participants discontinuing study early for given reason
3rd visit (6 months)
Number of Patients With Adverse Events (AE)
Time Frame: 6 months
6 months

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

April 1, 2010

Primary Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

April 19, 2010

First Submitted That Met QC Criteria

April 21, 2010

First Posted (Estimate)

April 22, 2010

Study Record Updates

Last Update Posted (Estimate)

March 28, 2014

Last Update Submitted That Met QC Criteria

February 28, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 502.592

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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