Observational Non-interventional Study (Anwendungsbeobachtung) With Telmisartan in High-risk Hypertensives

This study has been completed.

Sponsor:

Information provided by:

Boehringer Ingelheim

ClinicalTrials.gov Identifier:

NCT00539487

First received: September 25, 2007

Last updated: November 7, 2013

Last verified: November 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

September 25, 2007

Last Updated Date

November 7, 2013

Start Date ^ICMJE

January 2007

Primary Completion Date

November 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Blood pressure reduction [ Time Frame: 4 month ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00539487 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in metabolic parameters Safety [ Time Frame: n.a. ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Observational Non-interventional Study (Anwendungsbeobachtung) With Telmisartan in High-risk Hypertensives

Official Title ^ICMJE

TOP -Study Telmisartan - Therapy of Hypertension and Life-style Changes in Cardiovascular Risk Patients

Brief Summary

This observational non-interventional study will assess (under conditions of clinical practice in daily routine) the antihypertensive efficacy of telmisartan treatment with or without active promotion of lifestyle changes in hypertensive patients at high cardiovascular risk

Detailed Description

Study Design:

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

hypertensive patients

Condition ^ICMJE

Hypertension
Obesity

Intervention ^ICMJE

Not Provided

Study Groups/Cohorts

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

5827

Completion Date

Not Provided

Primary Completion Date

November 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

patients with essential hypertension aged >/= 18 years with one of the following risk factors: history of coronary artery disease or stroke/TIA or peripheral artery disease or diabetes mellitus.

Exclusion Criteria:

according to SPC

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Germany

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00539487

Other Study ID Numbers ^ICMJE

502.523
n.a.

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Boehringer Ingelheim, Study Chair, Boehringer Ingelheim

Study Sponsor ^ICMJE

Boehringer Ingelheim

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Boehringer Ingelheim

PRS Account

Boehringer Ingelheim

Verification Date

November 2013

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

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