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

NCT00904371 | Completed Results

• 1 other identifier: 502.585
• Study Type: observational
• Target: 211
• Locations: 1 country
• Sites: 36

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.

Conditions

Hypertension; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (6)

• 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)

  A 10 year risk of fatal cardiovascular disease (CVD) in populations at high risk. Minimum 0 percent risk to Maximum 47 percent risk.

  Baseline to 3rd visit (4-10 months)

• Change From Baseline in Framingham CVD Risk Assessment Score

  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).

  Baseline to 3rd visit (4-10 months)

• Change From Baseline in Framingham Stroke Risk Assessment Score

  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).

  Baseline to 3rd visit (4-10 months)

• Change From Baseline in Risk Assessment According to ESH/ESC Guidelines

  ESH is the European society of hypertension, and ESC is the European society of cardiology.

  Baseline to 3rd visit (4-10 months)

Secondary Outcomes (5)

• Pecentage of Patients That Achieved Target Blood Pressure (BP) Values According to ESH/ESC

  3rd visit (4-10 months)

• Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study)

  3rd visit (4-10 months)

• 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)

Study Arms (1)

Patients with arterial hypertention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with arterial hypertension with moderate to very high cardiovascular risk

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (36)

Boehringer Ingelheim Investigational Site 24

Brežice, Slovenia

Location

Boehringer Ingelheim Investigational Site 2

Brežice, Slovenia

Location

Boehringer Ingelheim Investigational Site 12

Celje, Slovenia

Location

Boehringer Ingelheim Investigational Site 16

Celje, Slovenia

Location

Boehringer Ingelheim Investigational Site 17

Celje, Slovenia

Location

Boehringer Ingelheim Investigational Site 1

Celje, Slovenia

Location

Boehringer Ingelheim Investigational Site 33

Celje, Slovenia

Location

Boehringer Ingelheim Investigational Site 18

Golnik, Slovenia

Location

Boehringer Ingelheim Investigational Site 23

Golnik, Slovenia

Location

Boehringer Ingelheim Investigational Site 29

Golnik, Slovenia

Location

Boehringer Ingelheim Investigational Site 32

Golnik, Slovenia

Location

Boehringer Ingelheim Investigational Site 15

Jesenice, Slovenia

Location

Boehringer Ingelheim Investigational Site 4

Kranj, Slovenia

Location

Boehringer Ingelheim Investigational Site 28

Litija, Slovenia

Location

Boehringer Ingelheim Investigational Site 26

Ljubljana, Slovenia

Location

Boehringer Ingelheim Investigational Site 35

Ljubljana, Slovenia

Location

Boehringer Ingelheim Investigational Site 3

Ljubljana, Slovenia

Location

Boehringer Ingelheim Investigational Site 6

Ljubljana, Slovenia

Location

Boehringer Ingelheim Investigational Site 14

Maribor, Slovenia

Location

Boehringer Ingelheim Investigational Site 22

Maribor, Slovenia

Location

Boehringer Ingelheim Investigational Site 20

Murska Sobota, Slovenia

Location

Boehringer Ingelheim Investigational Site 27

Murska Sobota, Slovenia

Location

Boehringer Ingelheim Investigational Site 31

Murska Sobota, Slovenia

Location

Boehringer Ingelheim Investigational Site 11

Novo Mesto, Slovenia

Location

Boehringer Ingelheim Investigational Site 19

Novo Mesto, Slovenia

Location

Boehringer Ingelheim Investigational Site 21

Novo Mesto, Slovenia

Location

Boehringer Ingelheim Investigational Site 9

Novo Mesto, Slovenia

Location

Boehringer Ingelheim Investigational Site 25

Sempeter, Slovenia

Location

Boehringer Ingelheim Investigational Site 30

Sempeter, Slovenia

Location

Boehringer Ingelheim Investigational Site 34

Sežana, Slovenia

Location

Boehringer Ingelheim Investigational Site 10

Slovenj Gradec, Slovenia

Location

Boehringer Ingelheim Investigational Site 36

Slovenj Gradec, Slovenia

Location

Boehringer Ingelheim Investigational Site 13

Topolšica, Slovenia

Location

Boehringer Ingelheim Investigational Site 5

Trbovlje, Slovenia

Location

Boehringer Ingelheim Investigational Site 8

Trbovlje, Slovenia

Location

Boehringer Ingelheim Investigational Site 7

Velenje, Slovenia

Location

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2009
• First Posted: May 19, 2009
• Study Start: December 1, 2009
• Primary Completion: January 1, 2011
• Last Updated: August 21, 2012
• Results First Posted: August 21, 2012

Record last verified: 2012-08

Locations

SL (36)