Telmisartan Tab Hypertension

N/ACompletedNCT00890084

Boehringer Ingelheim2,913 enrolled

Overview

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

Study Design:

Study Type

OBSERVATIONAL

Enrollment

2,913

Conditions

Hypertension

Interventions

Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Percentage of Patients With Blood Pressure < 140/90 mm Hg

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

Time frame: 12 weeks

Secondary Outcomes

Percentage of Patients With Blood Pressure < 130/80 mm Hg

Time frame: 12 weeks

Absolute Blood Pressure Decrease

systolic blood pressure

Time frame: baseline and 12 weeks

BP Response Rate (Drop of Systolic BP of 10mmHg or More)

BP response rate (drop of systolic BP of ≥ 10mmHg) after approximately 12 weeks of treatment with telmisartan (alone or in fixed combination with HCTZ)

Time frame: 12 weeks

Treatment Patterns

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).

Time frame: 12 weeks

Change in Concomitant Antihypertensive Drugs Given at Study Entry

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.

Time frame: baseline and 12 weeks

Percentage of Patients in Whom the Prescriber Decide to Further Lower the Blood Pressure to < 130/80 mm Hg

Time frame: 12 weeks

Percentage of Prescribers Who Adhered to European Society of Hypertension/European Society of Cardiology (ESH/ESC) Guidelines 2007

Data from ClinicalTrials.gov

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