Telmisartan Tab Hypertension

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Boehringer Ingelheim Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00890084

First received: April 28, 2009

Last updated: May 21, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 28, 2009

Last Updated Date

May 21, 2012

Start Date ^ICMJE

April 2009

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Percentage of Patients With Blood Pressure < 140/90 mm Hg [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

% of high risk patients with Blood Pressure < 140/90 mm Hg

Original Primary Outcome Measures ^ICMJE

To assess the overall effect of AHT with telmisartan after approx. 12 wks in GP and SP in uncontrolled hypertensive pnts with high and very high CV risk according ESH/ESC Guidelines 2007. [ Time Frame: approximately 3 months ]

Change History

Complete list of historical versions of study NCT00890084 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Percentage of Patients With Blood Pressure < 130/80 mm Hg [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Absolute Blood Pressure Decrease [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
systolic blood pressure
Change in Concomitant Antihypertensive Drugs Given at Study Entry [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
Percentage of patients who had a change in concomitant antihypertensive drugs prescribed at initiation and after 12 weeks. The antihypertensive drugs were changed (which is stopped, titration of dose and started) or not.
Percentage of Patients in Whom the Prescriber Decide to Further Lower the Blood Pressure to < 130/80 mm Hg [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Percentage of Prescribers Who Adhered to European Society of Hypertension/European Society of Cardiology (ESH/ESC) Guidelines 2007 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Blood pressure should be reduced to at least below 140/90 mm Hg (systolic/diastolic),and to lower values, if tolerated, in all hypertensive patients. Target blood pressure should be lower than 130/80 mmHg in diabetics and in high or very high risk patients

Original Secondary Outcome Measures ^ICMJE

Identify baseline factors, patterns of concomitant medication that can help predict effect of AHT with Telmisartan after approx. 12 weeks. Identify types prescribers who accept/or not deliberate deviation from target BP. [ Time Frame: approximately 3 months ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Telmisartan Tab Hypertension

Official Title ^ICMJE

RESPECT: Observational, Prospective, Open-label, Multi-center Study Evaluating the Antihypertensive Effect of Treatment With Telmisartan (Alone or in Fixed Combination With HCTZ) in General Practitioner and Specialist Practice in Hypertensive Patients With High and Very High Cardiovascular Risk According to the ESH/ESC Guidelines 2007 Who Are Uncontrolled Under Current Treatment.

Brief Summary

To assess the efficacy of telmisartan in hypertensive patients with 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

community sample

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Drug: Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)

Telmisartan 40mg or 80mg +/- HCTZ 12.5mg or 25mg

Study Group/Cohort (s)

Group1

Intervention: Drug: Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)

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

2913

Completion Date

Not Provided

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion criteria:

Hypertensive patients with BP. 140/90mmHgand high and very high cardiovascular risk according to the ESH/ESC Guidelines 2007 and in whom the prescriber has taken the decision to start treatment with telmisartan 40 or 80 mg, with or without HCTZ 12.5 mg or 25 mg, in the usual way and in line with the SmPC and reimbursement criteria

Exclusion criteria:

Contra-indications as in the Summary of Product Characteristics

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00890084

Other Study ID Numbers ^ICMJE

502.581

Has Data Monitoring Committee

Not Provided

Responsible Party

Boehringer Ingelheim Pharmaceuticals

Study Sponsor ^ICMJE

Boehringer Ingelheim Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

Information Provided By

Boehringer Ingelheim Pharmaceuticals

Verification Date

May 2012

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

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