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

Hypertension Clinical Trial

Official title:

Evaluation of the Effect of Telmisartan on Blood Pressure and Cardiovascular Risk Factor Index in High Risk Hypertensive Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00904371
• Other study ID #: 502.585
• Status: Completed
• Phase: N/A
• First received: May 18, 2009
• Last updated: August 16, 2012
• Start date: December 2009

Study information

• Verified date: August 2012
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovenia: Agency for Medicinal Products - Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hypertension

Locations

Country	Name	City	State
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 12	Celje
Slovenia	Boehringer Ingelheim Investigational Site 16	Celje
Slovenia	Boehringer Ingelheim Investigational Site 17	Celje
Slovenia	Boehringer Ingelheim Investigational Site 33	Celje
Slovenia	Boehringer Ingelheim Investigational Site 18	Golnik
Slovenia	Boehringer Ingelheim Investigational Site 23	Golnik
Slovenia	Boehringer Ingelheim Investigational Site 29	Golnik
Slovenia	Boehringer Ingelheim Investigational Site 32	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 26	Ljubljana
Slovenia	Boehringer Ingelheim Investigational Site 3	Ljubljana
Slovenia	Boehringer Ingelheim Investigational Site 35	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 27	Murska Sobota
Slovenia	Boehringer Ingelheim Investigational Site 31	Murska Sobota
Slovenia	Boehringer Ingelheim Investigational Site 11	Novo mesto
Slovenia	Boehringer Ingelheim Investigational Site 19	Novo mesto
Slovenia	Boehringer Ingelheim Investigational Site 21	Novo mesto
Slovenia	Boehringer Ingelheim Investigational Site 9	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 10	Slovenj Gradec
Slovenia	Boehringer Ingelheim Investigational Site 36	Slovenj Gradec
Slovenia	Boehringer Ingelheim Investigational Site 13	Topolsica
Slovenia	Boehringer Ingelheim Investigational Site 5	Trbovlje
Slovenia	Boehringer Ingelheim Investigational Site 8	Trbovlje
Slovenia	Boehringer Ingelheim Investigational Site 7	Velenje

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Systolic Blood Pressure (SBP)		Baseline to 3rd visit (4-10 months)	No
Primary	Change From Baseline in Diastolic Blood Pressure (DBP)		Baseline to 3rd visit (4-10 months)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Secondary	Pecentage of Patients That Achieved Target Blood Pressure (BP) Values According to ESH/ESC	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	3rd visit (4-10 months)	No
Secondary	Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study)	Participants may have taken more than one antihypertensive treatment, so the percentages will not add to 100 percent.	3rd visit (4-10 months)	No
Secondary	Change in Heart Rate From Baseline to Study End		Baseline to 3rd visit (4-10 months)	No
Secondary	Number of Patients With Adverse Events (AE)		4-10 months	No
Secondary	Number of Participants Not Completing Study	Number of participants discontinuing study early for given reason	3rd visit (4-10 months)	No