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

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ClinicalTrials.gov Identifier: NCT00539487

Recruitment Status : Completed

First Posted : October 4, 2007

Last Update Posted : November 8, 2013

Sponsor:

Information provided by:

Boehringer Ingelheim

Tracking Information

First Submitted Date

September 25, 2007

First Posted Date

October 4, 2007

Last Update Posted Date

November 8, 2013

Study Start Date

January 2007

Actual Primary Completion Date

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

Current Primary Outcome Measures

Blood pressure reduction [ Time Frame: 4 month ]

Original Primary Outcome Measures

Not Provided

Change History

Current Secondary Outcome Measures

Change in metabolic parameters Safety

Original Secondary Outcome Measures

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title

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

Official Title

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

Observational

Study Design

Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

hypertensive patients

Condition

Hypertension
Obesity

Intervention

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

Completed

Actual Enrollment

5827

Original Enrollment

10000

Study Completion Date

Not Provided

Actual Primary Completion Date

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

Eligibility Criteria

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, Older Adult)

Accepts Healthy Volunteers

Contacts

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries

Germany

Removed Location Countries

Administrative Information

NCT Number

NCT00539487

Other Study ID Numbers

502.523

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Current Responsible Party

Boehringer Ingelheim, Study Chair, Boehringer Ingelheim

Original Responsible Party

Not Provided

Current Study Sponsor

Boehringer Ingelheim

Original Study Sponsor

Same as current

Collaborators

Not Provided

Investigators

Study Chair:

Boehringer Ingelheim

PRS Account

Boehringer Ingelheim

Verification Date

November 2013

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