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

Completed

• Conditions: Hypertension; Cardiovascular Diseases

• Registration Number: NCT00904371
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2009-05-18
• Study First Submitted QC: 2009-05-18
• Study First Posted: 2009-05-19
• Study Start: 2009-12
• Primary Completion: 2011-01
• Results First Submitted: 2012-06-27
• Status Verified: 2012-08
• Results First Submitted QC: 2012-08-16
• Last Update Submitted: 2012-08-16
• Results First Posted: 2012-08-21
• Last Update Posted: 2012-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 211

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Systolic Blood Pressure (SBP)	Baseline to 3rd visit (4-10 months)
Change From Baseline in Diastolic Blood Pressure (DBP)	Baseline to 3rd visit (4-10 months)
Change From Baseline in SCORE (10 Year Risk for Fatal Cardiovascular Event)	Baseline to 3rd visit (4-10 months)	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	Baseline to 3rd visit (4-10 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).
Change From Baseline in Framingham Stroke Risk Assessment Score	Baseline to 3rd visit (4-10 months)	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	Baseline to 3rd visit (4-10 months)	ESH is the European society of hypertension, and ESC is the European society of cardiology.

Secondary Outcome Measures

Name	Time	Method
Pecentage of Patients That Achieved Target Blood Pressure (BP) Values According to ESH/ESC	3rd visit (4-10 months)	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)	3rd visit (4-10 months)	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	Baseline to 3rd visit (4-10 months)
Number of Patients With Adverse Events (AE)	4-10 months
Number of Participants Not Completing Study	3rd visit (4-10 months)	Number of participants discontinuing study early for given reason

Trial Locations

Locations (36)

Boehringer Ingelheim Investigational Site 23; 🇸🇮 Golnik, Slovenia

Boehringer Ingelheim Investigational Site 24; 🇸🇮 Brezice, Slovenia

Boehringer Ingelheim Investigational Site 32; 🇸🇮 Golnik, Slovenia

Boehringer Ingelheim Investigational Site 4; 🇸🇮 Kranj, Slovenia

Boehringer Ingelheim Investigational Site 28; 🇸🇮 Litija, Slovenia

Boehringer Ingelheim Investigational Site 14; 🇸🇮 Maribor, Slovenia

Boehringer Ingelheim Investigational Site 26; 🇸🇮 Ljubljana, Slovenia

Boehringer Ingelheim Investigational Site 20; 🇸🇮 Murska Sobota, Slovenia

Boehringer Ingelheim Investigational Site 7; 🇸🇮 Velenje, Slovenia

Boehringer Ingelheim Investigational Site 9; 🇸🇮 Novo mesto, Slovenia

Boehringer Ingelheim Investigational Site 30; 🇸🇮 Sempeter, Slovenia

Boehringer Ingelheim Investigational Site 36; 🇸🇮 Slovenj Gradec, Slovenia

Boehringer Ingelheim Investigational Site 16; 🇸🇮 Celje, Slovenia

Boehringer Ingelheim Investigational Site 33; 🇸🇮 Celje, Slovenia

Boehringer Ingelheim Investigational Site 17; 🇸🇮 Celje, Slovenia

Boehringer Ingelheim Investigational Site 2; 🇸🇮 Brezice, Slovenia

Boehringer Ingelheim Investigational Site 1; 🇸🇮 Celje, Slovenia

Boehringer Ingelheim Investigational Site 12; 🇸🇮 Celje, 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 35; 🇸🇮 Ljubljana, Slovenia

Boehringer Ingelheim Investigational Site 22; 🇸🇮 Maribor, Slovenia

Boehringer Ingelheim Investigational Site 6; 🇸🇮 Ljubljana, Slovenia

Boehringer Ingelheim Investigational Site 3; 🇸🇮 Ljubljana, Slovenia

Boehringer Ingelheim Investigational Site 11; 🇸🇮 Novo mesto, Slovenia

Boehringer Ingelheim Investigational Site 31; 🇸🇮 Murska Sobota, Slovenia

Boehringer Ingelheim Investigational Site 27; 🇸🇮 Murska Sobota, Slovenia

Boehringer Ingelheim Investigational Site 19; 🇸🇮 Novo mesto, Slovenia

Boehringer Ingelheim Investigational Site 21; 🇸🇮 Novo mesto, Slovenia

Boehringer Ingelheim Investigational Site 25; 🇸🇮 Sempeter, Slovenia

Boehringer Ingelheim Investigational Site 34; 🇸🇮 Sezana, 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