Clinical EvaluatioN of TElmisartan-based Antihypertensive Regimen

Boehringer Ingelheim15,268 enrolled

Overview

To determine the efficacy and safety of telmisartan-based treatment among patients with metabolic syndrome in actual setting in Philippines.

Study Type

OBSERVATIONAL

Enrollment

15,268

Conditions

Hypertension Metabolic Syndrome X

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age \> 45 years * Increased waist circumference (\>88.9cm \[\>35in\] men, \>78.7cm \[\>31in\] for women) * Elevated triglycerides (\>150mg/dl) * Low HDL cholesterol (\<40mg/dl in men, \<50mg/dl in women) * Hypertension (\>130/\>85mmHG) * Impaired fasting glucose (\>110mg/dl) (8) * Hypertensive patient assessed to benefit from telmisartan based treatment Exclusion Criteria: * Hypersensitivity to telmisartan, hydrochlorothiazide (HCTZ) and its excipients * \<3 months myocardial infarction (MI), stroke or severe heart failure

Locations (122)

Outcomes

Primary Outcomes

Response Rate at the End of 30 Day Period

Response rate of Blood Pressure assessed in the following categories: * Sitting SBP \< 130 mmHg and/or a reduction of \> 20 mmHg from baseline * Sitting DBP \< 85 mmHg and/or a reduction of \> 10 mmHg from baseline Sitting BP normalization \< 130 mmHg and DBP \< 85 mmHg

Time frame: End of 30 day Period

Response Rate at the End of 60 Day Period

Response rate on Blood Pressure: 1. Sitting SBP \< 130 mmHg and/or a reduction of \> 20 mmHg from baseline. 2. Sitting DBP \< 85 mmHg and/or a reduction of \> 10 mmHg from baseline. 3. Sitting BP normalization \< 130 mmHg and DBP \< 85 mmHg

Time frame: At the end of 60 day period

Change in Systolic Blood Pressure (SBP) From Baseline

Change in SBP = Value in visit 1(baseline) minus value in visit 3 (at 60-day treatment period)

Time frame: Baseline and 60 days

Change in Diastolic Blood Pressure (DBP) From Baseline

Change in DBP = Value in visit 1(baseline) minus value in visit 3 (at 60-day treatment period)

Time frame: Baseline and 60 days

Secondary Outcomes

Percentage of Patients With Presence of Metabolic Risk Factor

Presence of metabolic risk factor was identified by the existence of 3 out of the 5 risk factors namely: a.) presence of diabetes mellitus; b) presence of dyslipidemia; c) presence of albuminuria; d) presence of ventricular hypertrophy; and e) presence of co-morbidities, based on patients' Medical History

Time frame: At the end of 60 day period

Data from ClinicalTrials.gov

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