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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00904371
First received: May 18, 2009
Last updated: August 16, 2012
Last verified: August 2012
  Purpose

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


Condition
Hypertension
Cardiovascular Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Effect of Telmisartan on Blood Pressure and Cardiovascular Risk Factor Index in High Risk Hypertensive Patients

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change From Baseline in Systolic Blood Pressure (SBP) [ Time Frame: Baseline to 3rd visit (4-10 months) ] [ Designated as safety issue: No ]
  • Change From Baseline in Diastolic Blood Pressure (DBP) [ Time Frame: Baseline to 3rd visit (4-10 months) ] [ Designated as safety issue: No ]
  • Change From Baseline in SCORE (10 Year Risk for Fatal Cardiovascular Event) [ Time Frame: Baseline to 3rd visit (4-10 months) ] [ Designated as safety issue: No ]
    A 10 year risk of fatal cardiovascular disease (CVD) in populations at high risk. Minimum 0 percent risk to Maximum 47 percent risk.

  • Change From Baseline in Framingham CVD Risk Assessment Score [ Time Frame: Baseline to 3rd visit (4-10 months) ] [ Designated as safety issue: No ]
    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).

  • Change From Baseline in Framingham Stroke Risk Assessment Score [ Time Frame: Baseline to 3rd visit (4-10 months) ] [ Designated as safety issue: No ]
    The risk assessment tool using data from the Framingham Heart Study to estimate 10-year risk for stroke, measured in percent. Low risk (10 or less stroke risk at 10 years), intermediate risk (10-20), high risk (20 or more).

  • Change From Baseline in Risk Assessment According to ESH/ESC Guidelines [ Time Frame: Baseline to 3rd visit (4-10 months) ] [ Designated as safety issue: No ]
    ESH is the European society of hypertension, and ESC is the European society of cardiology.


Secondary Outcome Measures:
  • Pecentage of Patients That Achieved Target Blood Pressure (BP) Values According to ESH/ESC [ Time Frame: 3rd visit (4-10 months) ] [ Designated as safety issue: No ]
    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

  • Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study) [ Time Frame: 3rd visit (4-10 months) ] [ Designated as safety issue: No ]
    Participants may have taken more than one antihypertensive treatment, so the percentages will not add to 100 percent.

  • Change in Heart Rate From Baseline to Study End [ Time Frame: Baseline to 3rd visit (4-10 months) ] [ Designated as safety issue: No ]
  • Number of Patients With Adverse Events (AE) [ Time Frame: 4-10 months ] [ Designated as safety issue: No ]
  • Number of Participants Not Completing Study [ Time Frame: 3rd visit (4-10 months) ] [ Designated as safety issue: No ]
    Number of participants discontinuing study early for given reason


Enrollment: 211
Study Start Date: December 2009
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with arterial hypertention

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients with arterial hypertension with moderate to very high cardiovascular risk

Criteria

Inclusion criteria:

  • diagnosis of essential arterial hypertension (BP>140/90 mm HG or BP>130/80 mm Hg for diabetic patients)
  • at least an additional cardiovascular risk factor

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
  • pregnancy and lactation
  • diseases involving biliary obstruction
  • severe liver impairment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00904371

Locations
Slovenia
Boehringer Ingelheim Investigational Site 2
Brezice, Slovenia
Boehringer Ingelheim Investigational Site 24
Brezice, Slovenia
Boehringer Ingelheim Investigational Site 1
Celje, Slovenia
Boehringer Ingelheim Investigational Site 17
Celje, Slovenia
Boehringer Ingelheim Investigational Site 16
Celje, Slovenia
Boehringer Ingelheim Investigational Site 12
Celje, Slovenia
Boehringer Ingelheim Investigational Site 33
Celje, Slovenia
Boehringer Ingelheim Investigational Site 32
Golnik, Slovenia
Boehringer Ingelheim Investigational Site 23
Golnik, Slovenia
Boehringer Ingelheim Investigational Site 18
Golnik, Slovenia
Boehringer Ingelheim Investigational Site 29
Golnik, Slovenia
Boehringer Ingelheim Investigational Site 15
Jesenice, Slovenia
Boehringer Ingelheim Investigational Site 4
Kranj, Slovenia
Boehringer Ingelheim Investigational Site 28
Litija, Slovenia
Boehringer Ingelheim Investigational Site 35
Ljubljana, Slovenia
Boehringer Ingelheim Investigational Site 26
Ljubljana, Slovenia
Boehringer Ingelheim Investigational Site 3
Ljubljana, Slovenia
Boehringer Ingelheim Investigational Site 6
Ljubljana, Slovenia
Boehringer Ingelheim Investigational Site 14
Maribor, Slovenia
Boehringer Ingelheim Investigational Site 22
Maribor, Slovenia
Boehringer Ingelheim Investigational Site 20
Murska Sobota, Slovenia
Boehringer Ingelheim Investigational Site 31
Murska Sobota, Slovenia
Boehringer Ingelheim Investigational Site 27
Murska Sobota, Slovenia
Boehringer Ingelheim Investigational Site 11
Novo mesto, Slovenia
Boehringer Ingelheim Investigational Site 9
Novo mesto, Slovenia
Boehringer Ingelheim Investigational Site 21
Novo mesto, Slovenia
Boehringer Ingelheim Investigational Site 19
Novo mesto, Slovenia
Boehringer Ingelheim Investigational Site 25
Sempeter, Slovenia
Boehringer Ingelheim Investigational Site 30
Sempeter, Slovenia
Boehringer Ingelheim Investigational Site 34
Sezana, Slovenia
Boehringer Ingelheim Investigational Site 36
Slovenj Gradec, Slovenia
Boehringer Ingelheim Investigational Site 10
Slovenj Gradec, Slovenia
Boehringer Ingelheim Investigational Site 13
Topolsica, Slovenia
Boehringer Ingelheim Investigational Site 8
Trbovlje, Slovenia
Boehringer Ingelheim Investigational Site 5
Trbovlje, Slovenia
Boehringer Ingelheim Investigational Site 7
Velenje, Slovenia
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00904371     History of Changes
Other Study ID Numbers: 502.585
Study First Received: May 18, 2009
Results First Received: June 27, 2012
Last Updated: August 16, 2012
Health Authority: Slovenia: Agency for Medicinal Products - Ministry of Health

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypertension
Vascular Diseases
Telmisartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 26, 2014