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

Purpose

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

Condition
Hypertension Obesity


Study Type:	Observational
Study Design:	Time Perspective: Prospective
Official Title:	TOP -Study Telmisartan - Therapy of Hypertension and Life-style Changes in Cardiovascular Risk Patients

Resource links provided by NLM:

Drug Information available for: Telmisartan

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:

Blood pressure reduction [ Time Frame: 4 month ]

Secondary Outcome Measures:

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


Enrollment:	5827
Study Start Date:	January 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Detailed Description:

Study Design:

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

hypertensive patients

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00539487

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Sponsors and Collaborators

Boehringer Ingelheim

Investigators


Study Chair:	Boehringer Ingelheim	Boehringer Ingelheim

More Information


Responsible Party:	Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT00539487 History of Changes
Other Study ID Numbers:	502.523 n.a.
Study First Received:	September 25, 2007
Last Updated:	November 7, 2013
Health Authority:	Germany: BfArM (Bundesinstitut für Arzneimittel und Medizinalprodukte)

Additional relevant MeSH terms:


Hypertension Vascular Diseases Cardiovascular Diseases Telmisartan	Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2016

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