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:
Boehringer Ingelheim Pharmaceuticals
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00904371
First received: May 18, 2009
Last updated: August 16, 2012
Last verified: August 2012
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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:
MedlinePlus related topics:
High Blood Pressure
Drug Information available for:
Telmisartan
U.S. FDA Resources
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
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
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 Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Boehringer Ingelheim Pharmaceuticals |
| 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 May 19, 2013