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 - Tabular View

Tracking Information

First Received Date ^ICMJE

May 18, 2009

Last Updated Date

March 2, 2010

Start Date ^ICMJE

December 2009

Estimated Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The primary endpoint is treatment efficacy on reducing blood pressure and its ability to reduce cardiovascular risk. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

The primary endpoint is treatment efficacy on reducing blood pressure and its ability to reduce cardiovascular risk. [ Time Frame: 6 months ]

Change History

Complete list of historical versions of study NCT00904371 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Evaluation of antihypertensive treatment pattern; [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Determine number of patients (percentage) that achieve target blood pressure values according to the ESH/ESC values. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Evaluation of antihypertensive treatment pattern Determine number of patients (percentage) that achieve target blood pressure values according to the ESH/ESC values [ Time Frame: 6 months ]

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Cohort, Prospective

Condition ^ICMJE

Hypertension
Cardiovascular Diseases

Intervention ^ICMJE

Study Arms / Comparison Groups

Patients with arterial hypertention

Patients with essential hypertension (BP>140/90mm Hg or BP>130/80 mm Hg for diabetic patients) and at least one additional cardiovascular risk factor.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

250

Completion Date

Estimated Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Boehringer Ingelheim Call Center

1-800-243-0127

clintriage.rdg@boehringer-ingelheim.com

Location Countries ^ICMJE

Slovenia

Administrative Information

NCT ID ^ICMJE

NCT00904371

Responsible Party

Boehringer Ingelheim, Study Chair, Boehringer Ingelheim

Study ID Numbers ^ICMJE

502.585

Study Sponsor ^ICMJE

Boehringer Ingelheim Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

Information Provided By

Boehringer Ingelheim Pharmaceuticals

Verification Date

March 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP