Telmisartan Tab Hypertension

Completed

• Conditions: Hypertension
• Interventions: Drug: Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)

• Registration Number: NCT00890084
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To assess the efficacy of telmisartan in hypertensive patients with high cardiovascular risk

Detailed Description

Study Design:

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-28
• Study First Submitted QC: 2009-04-28
• Study First Posted: 2009-04-29
• Primary Completion: 2009-12
• Results First Submitted: 2011-12-30
• Results First Submitted QC: 2012-04-07
• Results First Posted: 2012-05-02
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-28
• Last Update Posted: 2014-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2913

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group1	Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)	-

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Blood Pressure < 140/90 mm Hg	12 weeks	% of high risk patients with Blood Pressure \< 140/90 mm Hg

Secondary Outcome Measures

Name	Time	Method
Absolute Blood Pressure Decrease	baseline and 12 weeks	systolic blood pressure
Change in Concomitant Antihypertensive Drugs Given at Study Entry	baseline and 12 weeks	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 With Blood Pressure < 130/80 mm Hg	12 weeks
BP Response Rate (Drop of Systolic BP of 10mmHg or More)	12 weeks	BP response rate (drop of systolic BP of ≥ 10mmHg) after approximately 12 weeks of treatment with telmisartan (alone or in fixed combination with HCTZ)
Treatment Patterns	12 weeks	Treatment patterns observed at the end of the study as Micardis monotherapy, Micardis Plus 12.5 and Micardis Plus 25 (with or without changes in concomitant antihypertensive medications).
Percentage of Patients in Whom the Prescriber Decide to Further Lower the Blood Pressure to < 130/80 mm Hg	12 weeks
Percentage of Prescribers Who Adhered to European Society of Hypertension/European Society of Cardiology (ESH/ESC) Guidelines 2007	12 weeks	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